The Department of Pharmaceuticals (DoP) has released the operational guidelines for the newly announced central sector scheme for Strengthening of Medical Device Industry (SMDI), aiming at providing

The Directorate General of Trade Remedies (DGTR), under the Ministry of Commerce and Industry, has issued a notice to all interested parties involved in the sunset review of the anti─dumping investigation

An inter─ministerial committee formed by the Union health ministry has recommended amendments to the Food Safety and Standards Act, 2006 and regulations on nutraceuticals and health supplements, to shift regulation of

The centrally sponsored scheme for strengthening of medical devices industry (SMDI), launched by the Central government last week, was widely welcomed by the medical devices industry in the country.

The National Accreditation Board for Testing and Calibration Laboratories (NABL), under the Quality Council of India (QCI), has announced a collaborative effort with Man─Made Textile Research Association (MANTRA) in Surat to deliver a specialized technical training programme on medical textiles testing.

TekniPlex Healthcare is set to unveil its strongest-ever reinforced paper for medical device packaging applications at Pack Expo 2024, 3-6 November in Chicago.

Rob Pitts, sales manager at Tri-Tech 3D, UK provider of Stratasys 3D printing solutions, explores how additive manufacturing (AM) can help speed up surgical workflows and reduce costs by transforming anatomical modelling.

A science photo book probes the colors we can see—and even “forbidden” colors we can’t

The new Trump administration is likely to reduce subsidies for Affordable Care Act insurance plans and roll back Medicaid coverage. Public health authorities worry that antivaccine activist Robert F. Kennedy, Jr., will be empowered

Outside groups often offer their solutions for climate adaptation in Africa. But the best people to manage the climate crisis are the people in those communities themselves. For climate adaptation to succeed in Africa, let communities and local leaders show the way

A fee created to push oil and gas companies to plug methane leaks could be axed by the incoming Trump administration, hampering efforts to curb the potent greenhouse gas

Researchers at Rice University have developed a magnetoelectric material that converts a magnetic field into an electric field. The material can be formulated such that it can be injected into the body, near a neuron, and then an alternating magnetic field can be applied to the area from outside the body. Magnetic fields are very […]

Today’s guest post comes from Josh Marsh, Vice President and General Manager, Sonexus™ Access and Patient Support at Cardinal Health

Josh discusses challenges manufacturers may face when outsourcing patient support programs. He outlines a process that smoothly transitions hubs and minimizes disruptions for patients and healthcare providers.

To learn more, download the 3-step guide to patient hub transitions.

Read on for Josh’s insights.
Read more »

Bonus Episode: Fast Facts on the ACRO D&I Grants Program ACRO’s Good Clinical Podcast is back with bonus episode! Host Sophia McLeod sat down with Tafoya Hubbard (ACRO Site Resource Grants Program Manager) and Kristen Surdam (ACRO D&I Steering Committee Member) to discuss ACRO’s new D&I Site Resource Grants Program. They provide background on the […]

The post Bonus Episode: ACRO’s Good Clinical Podcast first appeared on ACRO.

Today, ACRO is thrilled to announce the Good Clinical Podcast, where we take a look at the current state of clinical research and what direction the industry must head in to continue improving trials for patients. Host Sophia McLeod is joined by industry leaders to discuss the latest industry trends, cutting-edge innovation, and reflect on […]

The post Listen Now: ACRO’s Good Clinical Podcast Episode 1 first appeared on ACRO.

On the latest episode of ACRO’s Good Clinical Podcast, Dr. Tala Fakhouri (Associate Director for Data Science and Artificial Intelligence Policy, FDA) and Stephen Pyke (Chief Clinical Data & Digital Officer, Parexel) join the podcast to discuss how the FDA and regulators around the world are thinking about the use of AI in clinical research. […]

The post Listen Now: ACRO’s Good Clinical Podcast Episode 2 first appeared on ACRO.

On the latest episode of ACRO’s Good Clinical Podcast, Nicole Stansbury (SVP, Global Clinical Operations, Premier Research) and Madeleine Whitehead (RBQM Product & People Lead, Roche) join the podcast to discuss ACRO’s collaboration with TransCelerate BioPharma, Inc., the impact that ICH E6(R3) will have on Good Clinical Practice, and implications for innovation. They dive deeper […]

The post Listen Now: ACRO’s Good Clinical Podcast Episode 3 first appeared on ACRO.

RBQM: Moving Beyond a Belt & Suspenders Approach to Data Quality On the latest episode of ACRO’s Good Clinical Podcast, Danilo Branco (Director, Central Monitoring Operations, Fortrea), Cris McDavid (Director, Global Clinical Operations, RBQM, Parexel), and Valarie McGee (Senior Director, Clinical Systems Optimization, the PPD Clinical Research Business of Thermo Fisher Scientific) join the podcast […]

The post Listen Now: ACRO’s Good Clinical Podcast Episode 5 first appeared on ACRO.

The State of Clinical Trials in the UK: 2024 Update On the season 2 finale of ACRO’s Good Clinical Podcast, Steve Cutler (CEO, ICON plc) and Professor Lucy Chappell (CEO, NIHR) join the podcast to discuss the current clinical research landscape in the UK. They dive deeper into the competitive nature of bringing clinical research to a country, process-related challenges that need to […]

The post Listen Now: ACRO’s Good Clinical Podcast Episode 6 first appeared on ACRO.

I am pleased to announce the availability of on-demand training about FDA's regulation of advertising and promotion. So, you are now able to learn about the wonderful world of FDA ad-promo from the comfort of your home, office, or campsite. 

Effective on October 21st of this year, the Federal Trade Commission (FTC) issued a new final rule that is intended to better combat ​“fake” reviews and testimonials by prohibiting the sale or purchase of “fake reviews” as well as granting the agency the opportunity to seek civil penalties against ​willful violators. The FTC made only […]

Two former board chairs of the Coalition for Healthcare Communication (CHC) were named as the Medical Advertising Hall of Fame (MAHF) 2025 inductees – Sharon Callahan, former Chief Client Officer at Omnicom Health Group (OHG), and Nick Colucci, former Chairman and CEO of Publicis Health/COO of Publicis Groupe North America. The inductees will be honored […]

<p>The global biologicals market surged to an impressive US$419.07 billion in 2023. Blood and blood products led the market, commanding a dominant 66% share. Oncology stood out as the leading application segment, accounting for 36% of the market. North America held the largest revenue share, at 46%, while the Asia-Pacific region emerged as a rising star, poised to be the fastest-growing region over the next decade.</p>

The government implied wholesalers had more personal protective equipment in stock than was the case during the first wave of the COVID-19 pandemic, the Healthcare Distribution Association has said.

Community pharmacies should be reimbursed for their additional costs during the COVID-19 pandemic “as soon as possible”, the prime minister has told The Pharmaceutical Journal.

Pharmacy negotiators have discussed proposals to take “a patient registration-based approach” to the community pharmacy contractual framework.

By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drug development process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets. Identifying

The post Looking for Opportunities to Accelerate Clinical Research in Rare Diseases appeared first on LifeSciVC.

The UK body that oversees health research is writing a new strategy on clinical trial transparency and it wants to hear opinions on it. The Health Research Authority (HRA) says its strategy aims to “make transparency easy, make compliance clear and make information public.” It has opened a public consultation on the strategy and some […]

An AllTrials report for the House of Commons Science and Technology Select Committee this week has found that 33 NHS trust sponsors and six UK universities are reporting none of their clinical trial results, while others have gone from 0% to 100% following an announcement from the Select Committee in January that universities and NHS […]

New research has shown that the majority of clinical trials which should be following the US law on reporting results aren’t. Less than half (41%) of clinical trial results were reported on time and 1 in 3 trials (36%) remain unreported. The research also found that clinical trials sponsored by companies are the most likely […]

A judge in New York has ruled that hundreds of clinical trials registered on ClinicalTrials.gov are breaking the law by not reporting results. The ruling came in a court case launched against the US Department of Health and Human Services by two plaintiffs, a family doctor and a professor of journalism. The case focused on […]

Even by the already-painfully-embarrassingly-low standards of clinical trial enrollment in general, patient enrollment in cancer clinical trials is slow. Horribly slow. In many cancer trials, randomizing one patient every three or four months isn't bad at all – in fact, it's par for the course. The most
commonly-cited number is that only 3% of cancer patients participate in a trial – and although exact details of how that number is measured are remarkably difficult to pin down, it certainly can't be too far from reality.

Ultimately, the cost of slow enrollment is borne almost entirely by patients; their payment takes the form of fewer new therapies and less evidence to support their treatment decisions.

So when a couple dozen thousand of the world's top oncologists fly into Chicago to meet, you'd figure that improving accrual would be high on everyone’s agenda. You can't run your trial without patients, after all.

But every year, the annual ASCO meeting underdelivers in new ideas for getting more patients into trials. I suppose this a consequence of ASCO's members-only focus: getting the oncologists themselves to address patient accrual is a bit like asking NASCAR drivers to tackle the problems of aerodynamics, engine design, and fuel chemistry.

Nonetheless, every year, a few brave souls do try. Here is a quick rundown of accrual-related abstracts at this year’s meeting, conveniently sorted into 3 logical categories:

1. As Lord Kelvin may or may not have said, “If you cannot measure it, you cannot improve it.”

• Abstract e15572: Inadequate data availability on clinical trial accrual and its effect on progress in cancer research

Probably the most sensible of this year's crop, because rather than trying to make something out of nothing, the authors measure exactly how pervasive the nothing is. Specifically, they attempt to obtain fairly basic patient accrual data for the last three years' worth of clinical trials in kidney cancer. Out of 108 trials identified, they managed to get – via search and direct inquiries with the trial sponsors – basic accrual data for only 43 (40%).

That certainly qualifies as “terrible”, though the authors content themselves with “poor”.

Interestingly, exactly zero of the 32 industry-sponsored trials responded to the authors' initial survey. This fits with my impression that pharma companies continue to think of accrual data as proprietary, though what sort of business advantage it gives them is unclear. Any one company will have only run a small fraction of these studies, greatly limiting their ability to draw anything resembling a valid conclusion.

• Abstract TPS6645: Predictors of accrual success for cooperative group trials: The Cancer and Leukemia Group B (Alliance) experience

CALGB investigators look at 110 trials over the past 10 years to see if they can identify any predictive markers of successful enrollment. Unfortunately, the trials themselves are pretty heterogeneous (accrual periods ranged from 6 months to 8.8 years), so finding a consistent marker for successful trials would seem unlikely.

And, in fact, none of the usual suspects (e.g., startup time, disease prevalence) appears to have been significant. The exception was provision of medication by the study, which was positively associated with successful enrollment.

The major limitation with this study, apart from the variability of trials measured, is in its definition of “successful”, which is simply the total number of planned enrolled patients. Under both of their definitions, a slow-enrolling trial that drags on for years before finally reaching its goal is successful, whereas if that same trial had been stopped early it is counted as unsuccessful. While that sometimes may be the case, it's easy to imagine situations where allowing a slow trial to drag on is a painful waste of resources – especially if results are delayed enough to bring their relevance into question.

Even worse, though, is that a trial’s enrollment goal is itself a prediction. The trial steering committee determines how many sites, and what resources, will be needed to hit the number needed for analysis. So in the end, this study is attempting to identify predictors of successful predictions, and there is no reason to believe that the initial enrollment predictions were made with any consistent methodology.

2. If you don't know, maybe ask somebody?

• Abstract 8592: Strategies to overcome barriers to accrual (BtA) to NCI-sponsored clinical trials: A project of the NCI-Myeloma Steering Committee Accrual Working Group (NCI-MYSC AWG)
  
• Abstract 1596: Rapid online feedback to improve clinical trial accrual: CODEL anaplastic glioma (AG) (NCCTG/Alliance N0577) as a model

With these two abstracts we celebrate and continue the time-honored tradition of alchemy, whereby we transmute base opinion into golden data. The magic number appears to be 100: if you've got 3 digits' worth of doctors telling you how they feel, that must be worth something.

In the first abstract, a working group is formed to identify and vote on the major barriers to accrual in oncology trials. Then – and this is where the magic happens – that same group is asked to identify and vote on possible ways to overcome those barriers.

In the second, a diverse assortment of community oncologists were given an online survey to provide feedback on the design of a phase 3 trial in light of recent new data. The abstract doesn't specify who was initially sent the survey, so we cannot tell response rate, or compare survey responders to the general population (I'll take a wild guess and go with “massive response bias”).

Market research is sometimes useful. But what cancer clinical trial do not need right now are more surveys are working groups. The “strategies” listed in the first abstract are part of the same cluster of ideas that have been on the table for years now, with no appreciable increase in trial accrual.

3. The obligatory “What the What?” abstract

• Abstract 6564: Minority accrual on a prospective study targeting a diverse U.S. breast cancer population: An analysis of Wake Forest CCOP research base protocol 97609

The force with which my head hit my desk after reading this abstract made me concerned that it had left permanent scarring.

If this had been re-titled “Poor Measurement of Accrual Factors Leads to Inaccurate Accrual Reporting”, would it still have been accepted for this year’s meeting? That's certainly a more accurate title.

Let’s review: a trial intends to enroll both white and minority patients. Whites enroll much faster, leading to a period where only minority patients are recruited. Then, according to the authors, “an almost 4-fold increase in minority accrual raises question of accrual disparity.” So, sites will only recruit minority patients when they have no choice?

But wait: the number of sites wasn't the same during the two periods, and start-up times were staggered. Adjusting for actual site time, the average minority accrual rate was 0.60 patients/site/month in the first part and 0.56 in the second. So the apparent 4-fold increase was entirely an artifact of bad math.

This would be horribly embarrassing were it not for the fact that bad math seems to be endemic in clinical trial enrollment. Failing to adjust for start-up time and number of sites is so routine that not doing it is grounds for a presentation.

The bottom line

What we need now is to rigorously (and prospectively) compare and measure accrual interventions. We have lots of candidate ideas, and there is no need for more retrospective studies, working groups, or opinion polls to speculate on which ones will work best.  Where possible, accrual interventions should themselves be randomized to minimize confounding variables which prevent accurate assessment. Data needs to be uniformly and completely collected. In other words, the standards that we already use for clinical trials need to be applied to the enrollment measures we use to engage patients to participate in those trials.

This is not an optional consideration. It is an ethical obligation we have to cancer patients: we need to assure that we are doing all we can to maximize the rate at which we generate new evidence and test new therapies.

[Image credit: Logarithmic turtle accrual rates courtesy of Flikr user joleson.]

Results reporting requirements are pretty clear. Maybe critics should re-check their methods?

Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “fake fix” that was being thoroughly “ignored” by the pharmaceutical industry.

Pharma: breaking the law in broad daylight?

He makes this sweeping, unconditional proclamation about the industry and its regulators on the basis of  a single study in the BMJ, blithely ignoring the fact that a) the authors of the study admitted that they could not adequately determine the number of studies that were meeting FDAAA requirements and b) a subsequent FDA review that identified only 15 trials potentially out of compliance, out of a pool of thousands.


Despite the fact that the FDA, which has access to more data, says that only a tiny fraction of studies are potentially noncompliant, Goldacre's frequently repeated claims that the law is being ignored seems to have caught on in the general run of journalistic and academic discussions about FDAAA.

And now there appears to be additional support for the idea that a large percentage of studies are noncompliant with FDAAA results reporting requirements, in the form of a new study in the Journal of Clinical Oncology: "Public Availability of Results of Trials Assessing Cancer Drugs in the United States" by Thi-Anh-Hoa Nguyen, et al.. In it, the authors report even lower levels of FDAAA compliance – a mere 20% of randomized clinical trials met requirements of posting results on clinicaltrials.gov within one year.

Unsurprisingly, the JCO results were immediately picked up and circulated uncritically by the usual suspects.

I have to admit not knowing much about pure academic and cooperative group trial operations, but I do know a lot about industry-run trials – simply put, I find the data as presented in the JCO study impossible to believe. Everyone I work with in pharma trials is painfully aware of the regulatory environment they work in. FDAAA compliance is a given, a no-brainer: large internal legal and compliance teams are everywhere, ensuring that the letter of the law is followed in clinical trial conduct. If anything, pharma sponsors are twitchily over-compliant with these kinds of regulations (for example, most still adhere to 100% verification of source documentation – sending monitors to physically examine every single record of every single enrolled patient - even after the FDA explicitly told them they didn't have to).

I realize that’s anecdotal evidence, but when such behavior is so pervasive, it’s difficult to buy into data that says it’s not happening at all. The idea that all pharmaceutical companies are ignoring a highly visible law that’s been on the books for 6 years is extraordinary. Are they really so brazenly breaking the rules? And is FDA abetting them by disseminating incorrect information?

Those are extraordinary claims, and would seem to require extraordinary evidence. The BMJ study had clear limitations that make its implications entirely unclear. Is the JCO article any better?

Some Issues

In fact, there appear to be at least two major issues that may have seriously compromised the JCO findings:

1. Studies that were certified as being eligible for delayed reporting requirements, but do not have their certification date listed.

The study authors make what I believe to be a completely unwarranted assumption:

In trials for approval of new drugs or approval for a new indication, a certification [permitting delayed results reporting] should be posted within 1 year and should be publicly available.

It’s unclear to me why the authors think the certifications “should be” publicly available. In re-reading FDAAA section 801, I don’t see any reference to that being a requirement. I suppose I could have missed it, but the authors provide a citation to a page that clearly does not list any such requirement.

But their methodology assumes that all trials that have a certification will have it posted:

If no results were posted at ClinicalTrials.gov, we determined whether the responsible party submitted a certification. In this case, we recorded the date of submission of the certification to ClinicalTrials.gov.

If a sponsor gets approval from FDA to delay reporting (as is routine for all drugs that are either not approved for any indication, or being studied for a new indication – i.e., the overwhelming majority of pharma drug trials), but doesn't post that approval on the registry, the JCO authors deem that trial “noncompliant”. This is not warranted: the company may have simply chosen not to post the certification despite being entirely FDAAA compliant.

2. Studies that were previously certified for delayed reporting and subsequently reported results

It is hard to tell how the authors treated this rather-substantial category of trials. If a trial was certified for delayed results reporting, but then subsequently published results, the certification date becomes difficult to find. Indeed, it appears in the case where there were results, the authors simply looked at the time from study completion to results posting. In effect, this would re-classify almost every single one of these trials from compliant to non-compliant. Consider this example trial:

• Phase 3 trial completes January 2010
• Certification of delayed results obtained December 2010 (compliant)
• FDA approval June 2013
• Results posted July 2013 (compliant)

In looking at the JCO paper's methods section, it really appears that this trial would be classified as reporting results 3.5 years after completion, and therefore be considered noncompliant with FDAAA. In fact, this trial is entirely kosher, and would be extremely typical for many phase 2 and 3 trials in industry.

Time for Some Data Transparency

The above two concerns may, in fact, be non-issues. They certainly appear to be implied in the JCO paper, but the wording isn't terribly detailed and could easily be giving me the wrong impression.

However, if either or both of these issues are real, they may affect the vast majority of "noncompliant" trials in this study. Given the fact that most clinical trials are either looking at new drugs, or looking at new indications for new drugs, these two issues may entirely explain the gap between the JCO study and the unequivocal FDA statements that contradict it.

I hope that, given the importance of transparency in research, the authors will be willing to post their data set publicly so that others can review their assumptions and independently verify their conclusions. It would be more than a bit ironic otherwise.
Thi-Anh-Hoa Nguyen, Agnes Dechartres, Soraya Belgherbi, and Philippe Ravaud (2013). Public Availability of Results of Trials Assessing Cancer Drugs in the United States JOURNAL OF CLINICAL ONCOLOGY DOI: 10.1200/JCO.2012.46.9577

This morning I ran across a bit of a coffee-spitter: in the middle of an otherwise opaquely underinformative press release fromTranscelerate Biopharma about the launch of their

Counterfeits flooding the market? Really?

"Comparator Network" - which will perhaps streamline member companies' ability to obtain drugs from each other for clinical trials using active comparator arms -  the CEO of the consortium, Dalvir Gill, drops a rather remarkable quote:

"Locating and accessing these comparators at the right time, in the right quantities and with the accompanying drug stability and regulatory information we need, doesn't always happen efficiently. This is further complicated by infiltration of the commercial drug supply chain by counterfeit drugs.  With the activation of our Comparator Network the participating TransCelerate companies will be able to source these comparator drugs directly from each other, be able to secure supply when they need it in the quantities they need, have access to drug data and totally mitigate the risk of counterfeit drugs in that clinical trial."

Counterfeit drugs have even been known to have been involved in clinical drug trials.^{[citation needed]}

There has been considerable noise coming out of the UK lately about successes in clinical trial enrollment.

First, a couple months ago came the rather dramatic announcement that clinical trial participation in the UK had "tripled over the last 6 years". That announcement, by the chief executive of the

Sweet creature of bombast: is Sir John writing press releases for the NIHR?

National Institute of Health Research's Clinical Research Network, was quickly and uncritically picked up by the media.

That immediately caught my attention. In large, global trials, most pharmaceutical companies I've worked with can do a reasonable job of predicting accrual levels in a given country. I like to think that if participation rates in any given country had jumped that heavily, I’d have heard something.

(To give an example: looking at a quite-typical study I worked on a few years ago: UK sites were overall slightly below the global average. The highest-enrolling countries were about 2.5 times as fast. So, a 3-fold increase in accruals would have catapulted the UK from below average to the fastest-enrolling country in the world.)

Further inquiry, however, failed to turn up any evidence that the reported tripling actually corresponded to more human beings enrolled in clinical trials. Instead, there is some reason to believe that all we witnessed was increased reporting of trial participation numbers.

Now we have a new source of wonder, and a new giant multiplier coming out of the UK. As the Director of the NIHR's Mental Health Research Network, Til Wykes, put it in her blog coverage of her own paper:

Our research on the largest database of UK mental health studies shows that involving just one or two patients in the study team means studies are 4 times more likely to recruit successfully.

Again, amazing! And not just a tripling – a quadrupling!

Understand: I spend a lot of my time trying to convince study teams to take a more patient-focused approach to clinical trial design and execution. I desperately want to believe this study, and I would love having hard evidence to bring to my clients.

At first glance, the data set seems robust. From the King's College press release:

Published in the British Journal of Psychiatry, the researchers analysed 374 studies registered with the Mental Health Research Network (MHRN).

Studies which included collaboration with service users in designing or running the trial were 1.63 times more likely to recruit to target than studies which only consulted service users.  Studies which involved more partnerships - a higher level of Patient and Public Involvement (PPI) - were 4.12 times more likely to recruit to target.

But here the first crack appears. It's clear from the paper that the analysis of recruitment success was not based on 374 studies, but rather a much smaller subset of 124 studies. That's not mentioned in either of the above-linked articles.

And at this point, we have to stop, set aside our enthusiasm, and read the full paper. And at this point, critical doubts begin to spring up, pretty much everywhere.

First and foremost: I don’t know any nice way to say this, but the "4 times more likely" line is, quite clearly, a fiction. What is reported in the paper is a 4.12 odds ratio between "low involvement" studies and "high involvement" studies (more on those terms in just a bit).  Odds ratios are often used in reporting differences between groups, but they are unequivocally not the same as "times more likely than".

This is not a technical statistical quibble. The authors unfortunately don’t provide the actual success rates for different kinds of studies, but here is a quick example that, given other data they present, is probably reasonably close:

• A Studies: 16 successful out of 20 
• Probability of success: 80% 
• Odds of success: 4 to 1
• B Studies: 40 successful out of 80
• Probability of success: 50%
• Odds of success: 1 to 1

From the above, it’s reasonable to conclude that A studies are 60% more likely to be successful than B studies (the A studies are 1.6 times as likely to succeed). However, the odds ratio is 4.0, similar to the difference in the paper. It makes no sense to say that A studies are 4 times more likely to succeed than B studies.

This is elementary stuff. I’m confident that everyone involved in the conduct and analysis of the MHRN paper knows this already. So why would Dr Wykes write this? I don’t know; it's baffling. Maybe someone with more knowledge of the politics of British medicine can enlighten me.

If a pharmaceutical company had promoted a drug with this math, the warning letters and fines would be flying in the door fast. And rightly so. But if a government leader says it, it just gets recycled verbatim.

The other part of Dr Wykes's statement is almost equally confusing. She claims that the enrollment benefit occurs when "involving just one or two patients in the study team". However, involving one or two patients would seem to correspond to either the lowest ("patient consultation") or the middle level of reported patient involvement (“researcher initiated collaboration”). In fact, the "high involvement" categories that are supposed to be associated with enrollment success are studies that were either fully designed by patients, or were initiated by patients and researchers equally. So, if there is truly a causal relationship at work here, improving enrollment would not be merely a function of adding a patient or two to the conversation.

There are a number of other frustrating aspects of this study as well. It doesn't actually measure patient involvement in any specific research program, but uses just 3 broad categories (that the researchers specified at the beginning of each study). It uses an arbitrary and undocumented 17-point scale to measure "study complexity", which collapses and quite likely underweights many critical factors into a single number. The enrollment analysis excluded 11 studies because they weren't adequate for a factor that was later deemed non-significant. And probably the most frustrating facet of the paper is that the authors share absolutely no descriptive data about the studies involved in the enrollment analysis. It would be completely impossible to attempt to replicate its methods or verify its analysis. Do the authors believe that "Public Involvement" is only good when it’s not focused on their own work?

However, my feelings about the study and paper are an insignificant fraction of the frustration I feel about the public portrayal of the data by people who should clearly know better. After all, limited evidence is still evidence, and every study can add something to our knowledge. But the public misrepresentation of the evidence by leaders in the area can only do us harm: it has the potential to actively distort research priorities and funding.

Why This Matters

We all seem to agree that research is too slow. Low clinical trial enrollment wastes time, money, and the health of patients who need better treatment options.

However, what's also clear is that we lack reliable evidence on what activities enable us to accelerate the pace of enrollment without sacrificing quality. If we are serious about improving clinical trial accrual, we owe it to our patients to demand robust evidence for what works and what doesn’t. Relying on weak evidence that we've already solved the problem ("we've tripled enrollment!") or have a method to magically solve it ("PPI quadrupled enrollment!") will cause us to divert significant time, energy, and human health into areas that are politically favored but less than certain to produce benefit. And the overhyping those results by research leadership compounds that problem substantially. NIHR leadership should reconsider its approach to public discussion of its research, and practice what it preaches: critical assessment of the data.
Ennis L, & Wykes T (2013). Impact of patient involvement in mental health research: longitudinal study. The British journal of psychiatry : the journal of mental science PMID: 24029538

NPR's Leila Fadel talks with actor Patrick Dempsey about his efforts to raise money for cancer treatment and prevention.

The National Institutes of Health, the crown jewel of biomedical research in the U.S., could face big changes under the new Trump administration, some fueled by pandemic-era criticisms of the agency.

Journalist Annie Lowrey has a rare disease that causes a near-constant itch that doesn't respond to most treatments. She likens the itchiness to a car alarm: "You can't stop thinking about it."

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This article is part of our exclusive IEEE Journal Watch series in partnership with IEEE Xplore.

Sea turtles are remarkable creatures for a number of reasons, including the way they hear underwater—not through openings in the form of ears, but by detecting vibrations directly through the skin covering their auditory system. Inspired by this ability to detect sound through skin, researchers in China have created a heart-monitoring system, which initial tests in humans suggest may be a viable for monitoring heartbeats.

A key way in which doctors monitor heart health involves “listening” to the heartbeat, either using a stethoscope or more sophisticated technology, like echocardiograms. However, these approaches require a visit to a specialist, and so researchers have been keen to develop alternative, lower cost solutions that people can use at home, which could also allow for more frequent testing and monitoring.

Junbin Zang, a lecturer at the North University of China, and his colleagues specialize in creating heart-monitoring technologies. Their interest was piqued when they learned about the inner workings of the sea turtle’s auditory system, which is able to detect low-frequency signals, especially in the 300- to 400-hertz range.

“Heart sounds are also low-frequency signals, so the low-frequency characteristics of the sea turtle’s ear have provided us with great inspiration,” explains Zang.

At a glance, it looks like turtles don’t have ears. Their auditory system instead lies under a layer of skin and fat, through which it picks up vibrations. As with humans, a small bone in the ear vibrates as sounds hit it, and as it oscillates, those pulses are converted to electrical signals that are sent to the brain for processing and interpretation.

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But sea turtles have a unique, slender T-shaped conduit that encapsulates their ear bones, restricting the movement of the similarly T-shaped ear bones to only vibrate in a perpendicular manner. This design provides their auditory system with high sensitivity to vibrations.

Zang and his colleagues set out to create a heart monitoring system with similar features. They created a T-shaped heart-sound sensor that imitates the ear bones of sea turtles using a tiny MEMS cantilever beam sensor. As sound hits the sensor, the vibrations cause deformations in its beam, and the fluctuations in the voltage resistance are then translated into electrical signals.

The researchers first tested the sensor’s ability to detect sound in lab tests, and then tested the sensor’s ability to monitor heartbeats in two human volunteers in their early 20s. The results, described in a study published 1 April in IEEE Sensors Journal, show that the sensor can effectively detect the two phases of a heartbeat.

“The sensor exhibits excellent vibration characteristics,” Zang says, noting that it has a higher vibration sensitivity compared to other accelerometers on the market.

However, the sensor currently picks up a significant amount of background noise, which Zang says his team plans to address in future work. Ultimately, they are interested in integrating this novel bioinspired sensor into devices they have previously created—including portable handheld and wearable versions, and a relatively larger version for use in hospitals—for the simultaneous detection of electrocardiogram and phonocardiogram signals.

This article appears in the July 2024 print issue as “Sea Turtles Inspire Heart-Monitor Design.”

In 2010, Melanie Reid fell off a horse and was paralyzed below the shoulders.

“You think, ‘I am where I am; nothing’s going to change,’ ” she said, but many years after her accident, she participated in a medical trial of a new, noninvasive rehabilitative device that can deliver more electrical stimulation than similar devices without harming the user. For Reid, use of the device has led to small improvements in her ability to use her hands, and meaningful changes to her daily life.

“Everyone thinks with spinal injury all you want to do is be able to walk again, but if you’re a tetraplegic or quadriplegic, what matters most is working hands,” said Reid, a columnist for The Times, as part of a press briefing. “There’s no miracles in spinal injury, but tiny gains can be life-changing.”

For the study, Reid used a new noninvasive therapeutic device produced by Onward Medical. The device, ARC-EX (“EX” indicating “external”), uses electrodes placed along the spine near the site of injury—in the case of quadriplegia, the neck—to promote nerve activity and growth during physical-therapy exercises. The goal is to not only increase motor function while the device is attached and operating, but the long-term effectiveness of rehabilitation drills. A study focused on arm and hand abilities in patients with quadriplegia was published 20 May in Nature Medicine.

Researchers have been investigating electrical stimulation as a treatment for spinal cord injury for roughly 40 years, but “one of the innovations in this system is using a very high-frequency waveform,” said coauthor Chet Moritz, a neurotechnologist at the University of Washington. The ARC-EX uses a 10-kilohertz carrier frequency overlay, which researchers think may numb the skin beneath the electrode, allowing patients to tolerate five times as much amperage as from similar exploratory devices. For Reid, this manifested as a noticeable “buzz,” which felt strange, but not painful.

The study included 60 participants across 14 sites around the world. Each participant undertook two months of standard physical therapy, followed by two months of therapy combined with the ARC-EX. Although aspects of treatment such as electrode placement were fairly standardized, the current amplitude was personalized to each patient, and sometimes individual exercises, said Moritz.

The ARC-EX uses a 10-kilohertz current to provider stronger stimulation for people with spinal cord injuries.

Over 70 percent of patients showed an increase in at least one measurement of both strength and function between standard therapy and ARC-EX therapy. These changes also meant that 87 percent of study participants noted some improvement in quality of life in a followup questionnaire. No major safety concerns tied to the device or rehabilitation process were reported.

Onward will seek approval from the U.S. Food and Drug Administration for the device by the end of 2024, said study coauthor Grégoire Courtine, a neuroscientist and cofounder of Onward Medical. Onward is also working on an implantable spinal stimulator called ARC-IM; other prosthetic approaches, such as robotic exoskeletons, are being investigated elsewhere. ARC-EX was presented as a potentially important cost-accessible, noninvasive treatment option, especially in the critical window for recovery a year or so after a spinal cord injury. However, the price to insurers or patients of a commercial version is still subject to negotiation.

The World Health Organization says there are over 15 million people with spinal cord injuries. Moritz estimates that around 90 percent of patients, even many with no movement in their hands, could benefit from the new therapy.

Dimitry Sayenko, who studies spinal cord injury recovery at Houston Methodist and was not involved in the study, praised the relatively large sample size and clear concern for patient safety. But he stresses that the mechanisms underlying spinal stimulation are not well understood. “So far it’s literally plug and play,” said Sayenko. “We don’t understand what’s happening under the electrodes for sure—we can only indirectly assume or speculate.”

The new study supports the idea that noninvasive spinal cord stimulation can provide some benefit to some people but was not designed to help predict who will benefit, precisely how people will benefit, or how to optimize care. The study authors acknowledged the limited scope and need for further research, which might help turn currently “tiny gains” into what Sayenko calls “larger, more dramatic, robust effects.”

The future of an innovative retinal implant and dozens of its users just got brighter, after Science, a bioelectronics startup run by Neuralink’s cofounder, Max Hodak, acquired Pixium’s technology at the last minute.

Pixium Vision, whose Prima system to tackle vision loss is implanted in 47 people across Europe and the United States, was in danger of disappearing completely until Science stepped in to buy the French company’s assets in April, for an undisclosed amount.

Pixium has been developing Prima for a decade, building on work by Daniel Palanker, a professor of ophthalmology at Stanford University. The 2-by-2-millimeter square implant is surgically implanted under the retina, where it turns infrared data from camera-equipped glasses into pulses of electricity. These replace signals generated by photoreceptor rods and cones, which are damaged in people suffering from age-related macular degeneration (AMD).

Early feasibility studies in the E.U. and the United States suggested Prima was safe and potentially effective, but Pixium ran out of money last November before the final results of a larger, multiyear pivotal trial in Europe.

“It’s very important to us to avoid another debacle like Argus II.”

With the financial and legal clock ticking down, the trial data finally arrived in March this year. “And the results from that were just pretty stunning,” says Max Hodak, Science’s founder and CEO, in his first interview since the acquisition.

Although neither Pixium nor Science has yet released the full dataset, Hodak shared with IEEE Spectrum videos of three people using Prima, each of them previously unable to read or recognize faces due to AMD. The videos show them slowly but fluently reading a hardback book, filling in a crossword puzzle, and playing cards.

“This is legit ‘form vision’ that I don’t think any device has ever done,” says Hodak. Form vision is the ability to recognize visual elements as parts of a larger object. “It’s this type of data that convinced us. And from there we were like, this should get to patients.”

As well as buying the Prima technology, Hodak says that Science will hire the majority of Pixium’s 35 engineering and regulatory staff, in a push to get the technology approved in Europe as quickly as possible.

The Prima implant receives visual data and is powered by near-infrared signals beamed from special spectacles.Pixium

Another priority is supporting existing Prima patients, says Lloyd Diamond, Pixium’s outgoing CEO. “It’s very important to us to avoid another debacle like Argus II,” he says, referring to another retinal implant whose manufacturer went out of business in 2022, leaving users literally in the dark.

Diamond is excited to be working with Science, which is based in Silicon Valley with a chip foundry in North Carolina. “They have a very deep workforce in software development, in electronic development, and in biologic research,” he says. “And there are probably only a few foundries in the world that could manufacture an implant such as ours. Being able to internalize part of that process is a very big advantage.”

Hodak hopes that a first-generation Prima product could quickly be upgraded with a wide-angle camera and the latest electronics. “We think that there’s one straight shrink, where we’ll move to smaller pixels and get higher visual acuity,” he says. “After that, we’ll probably move to a 3D electrode design, where we’ll be able to get closer to single-cell resolution.” That could deliver even sharper artificial vision.

In parallel, Science will continue Pixium’s discussions with the FDA in the United States about advancing a clinical trial there.

The success of Prima is critical, says Hodak, who started Science in 2021 after leaving Neuralink, a brain-computer interface company he cofounded with Elon Musk. “Elon can do whatever he wants for as long as he wants, but we need something that can finance future development,” he says. “Prima is big enough in terms of impact to patients and society that it is capable of helping us finance the rest of our ambitions.”

These include a next-generation Prima device, which Hodak says he is already talking about with Palanker, and a second visual prosthesis, currently called the Science Eye. This will tackle retinitis pigmentosa, a condition affecting peripheral vision—the same condition targeted by Second Sight’s ill-fated Argus II device.

“The Argus II just didn’t work that well,” says Hodak. “In the end, it was a pure bridge to nowhere.” Like the Argus II and Prima, the Science Eye relies on camera glasses and an implant, but with the addition of optogenetic therapy. This uses a genetically engineered virus to deliver a gene to specific optic nerve cells in the retina, making them light-sensitive at a particular wavelength. A tiny implanted display with a resolution sharper than an iPhone screen then enables fine control over the newly sensitized cells.

That system is still undergoing animal trials, but Hodak is almost ready to pull the trigger on its first human clinical studies, likely in Australia and New Zealand.

“In the long term, I think precision optogenetics will be more powerful than Prima’s electrical stimulation,” he says. “But we’re agnostic about which approach works to restore vision.”

One thing he does believe vehemently, unlike Musk, is that the retina is the best place to put an implant. Neuralink and Cortigent (the successor company of Second Sight) are both working on prosthetics that target the brain’s visual cortex.

“There’s a lot that you can do in cortex, but vision is not one of them,” says Hodak. He thinks the visual cortex is too complex, too distributed, and too difficult to access surgically to be useful.

“As long as the optic nerve is intact, the retina is the ideal place to think about restoring vision to the brain,” he says. “This is all a question of effect size. If someone has been in darkness for a decade, with no light, no perception, and you can give them any type of visual stimulus, they’re going to be into it. The Pixium patients can intuitively read, and that was really what convinced us that this was worth picking up and pursuing.”

For people with diabetes, glucose monitors are a valuable tool to monitor their blood sugar. The current generation of these biosensors detect glucose levels with thin, metallic filaments inserted in subcutaneous tissue, the deepest layer of the skin where most body fat is stored.

Medical technology company Biolinq is developing a new type of glucose sensor that doesn’t go deeper than the dermis, the middle layer of skin that sits above the subcutaneous tissue. The company’s “intradermal” biosensors take advantage of metabolic activity in shallower layers of skin, using an array of electrochemical microsensors to measure glucose—and other chemicals in the body—just beneath the skin’s surface.

Biolinq just concluded a pivotal clinical trial earlier this month, according to CEO Rich Yang, and the company plans to submit the device to the U.S. Food and Drug Administration for approval at the end of the year. In April, Biolinq received US $58 million in funding to support the completion of its clinical trials and subsequent submission to the FDA.

Biolinq’s glucose sensor is “the world’s first intradermal sensor that is completely autonomous,” Yang says. While other glucose monitors require a smartphone or other reader to collect and display the data, Biolinq’s includes an LED display to show when the user’s glucose is within a healthy range (indicated by a blue light) or above that range (yellow light). “We’re providing real-time feedback for people who otherwise could not see or feel their symptoms,” Yang says. (In addition to this real-time feedback, the user can also load long-term data onto a smartphone by placing it next to the sensor, like Abbott’s FreeStyle Libre, another glucose monitor.)

More than 2,000 microsensor components are etched onto each 200-millimeter silicon wafer used to manufacture the biosensors.Biolinq

Biolinq’s hope is that its approach could lead to sustainable changes in behavior on the part of the individual using the sensor. The device is intentionally placed on the upper forearm to be in plain sight, so users can receive immediate feedback without manually checking a reader. “If you drink a glass of orange juice or soda, you’ll see this go from blue to yellow,” Yang explains. That could help users better understand how their actions—such as drinking a sugary beverage—change their blood sugar and take steps to reduce that effect.

Biolinq’s device consists of an array of microneedles etched onto a silicon wafer using semiconductor manufacturing. (Other glucose sensors’ filaments are inserted with an introducer needle.) Each chip has a small 2-millimeter by 2-millimeter footprint and contains seven independent microneedles, which are coated with membranes through a process similar to electroplating in jewelry making. One challenge the industry has faced is ensuring that microsensors do not break at this small scale. The key engineering insight Biolinq introduced, Yang says, was using semiconductor manufacturing to build the biosensors. Importantly, he says, silicon “is harder than titanium and steel at this scale.”

Miniaturization allows for sensing closer to the surface of the skin, where there is a high level of metabolic activity. That makes the shallow depth ideal for monitoring glucose, as well as other important biomarkers, Yang says. Due to this versatility, combined with the use of a sensor array, the device in development can also monitor lactate, an important indicator of muscle fatigue. With the addition of a third data point, ketones (which are produced when the body burns fat), Biolinq aims to “essentially have a metabolic panel on one chip,” Yang says.

Using an array of sensors also creates redundancy, improving the reliability of the device if one sensor fails or becomes less accurate. Glucose monitors tend to drift over the course of wear, but with multiple sensors, Yang says that drift can be better managed.

One downside to the autonomous display is the drain on battery life, Yang says. The battery life limits the biosensor’s wear time to 5 days in the first-generation device. Biolinq aims to extend that to 10 days of continuous wear in its second generation, which is currently in development, by using a custom chip optimized for low-power consumption rather than off-the-shelf components.

The company has collected nearly 1 million hours of human performance data, along with comparators including commercial glucose monitors and venous blood samples, Yang says. Biolinq aims to gain FDA approval first for use in people with type 2 diabetes not using insulin and later expand to other medical indications.

This article appears in the August 2024 print issue as “Glucose Monitor Takes Page From Chipmaking.”

For the first time, a small group of patients with amputations below the knee were able to control the movements of their prosthetic legs through neural signals—rather than relying on programmed cycles for all or part of a motion—and resume walking with a natural gait. The achievement required a specialized amputation surgery combined with a non-invasive surface electrode connection to a robotic prosthetic lower leg. A study describing the technologies was published today in the journal Nature Medicine.

“What happens then is quite miraculous. The patients that have this neural interface are able to walk at normal speeds; and up and down steps and slopes; and maneuver obstacles really without thinking about it. It’s natural. It’s involuntary,” said co-author Hugh Herr, who develops bionic prosthetics at the MIT Media Lab. “Even though their limb is made of titanium and silicone—all these various electromechanical components—the limb feels natural and it moves naturally, even without conscious thought.”

The approach relies on surgery at the amputation site to create what the researchers call an agonist-antagonist myoneural Interface, or AMI. The procedure involves connecting pairs of muscles (in the case of below-the-knee amputation, two pairs), as well as the introduction of proprietary synthetic elements.

The interface creates a two-way connection between body and machine. Muscle-sensing electrodes send signals to a small computer in the prosthetic limb that interprets them as angles and forces for joints at the ankle and ball of the foot. It also sends information back about the position of the artificial leg, restoring a sense of where the limb is in space, also known as proprioception.

Video 1 www.youtube.com

“The particular mode of control is far beyond what anybody else has come up with,” said Daniel Ferris, a neuromechanical engineer at the University of Florida; Ferris was not involved in the study, but has worked on neural interfaces for controlling lower limb prostheses. “It’s a really novel idea that they’ve built on over the last eight years that’s showing really positive outcomes for better bionic lower legs.” The latest publication is notable for a larger participant pool than previous studies, with seven treatment patients and seven control patients with amputations and typical prosthetic legs.

To test the bionic legs, patients were asked to walk on level ground at different speeds; up and down slopes and stairs; and to maneuver around obstacles. The AMI users had a more natural gait, more closely resembling movement by someone using a natural limb. More naturalistic motion can improve freedom of movement, particularly over challenging terrain, but in other studies researchers have also noted reduced energetic costs, reduced stress on the body, and even social benefits for some amputees.

Co-author Hyungeun Song, a postdoctoral researcher at MIT, says the group was surprised by the efficiency of the bionic setup. The prosthetic interface sent just 18 percent of the typical amount of information that’s sent from a limb to the spine, yet it was enough to allow patients to walk with what was considered a normal gait.

Next Steps for the Bionic Leg

AMI amputations have now become the standard at Brigham and Women’s Hospital in Massachusetts, where co-author Matthew Carty works. And because of patient benefits in terms of pain and ease of using even passive (or non-robotic) prosthetics, this technique—or something similar—could spread well beyond the current research setting. To date, roughly 60 people worldwide have received AMI surgery above or below either an elbow or knee.

In principle, Herr said, someone with a previously amputated limb, such as himself, could undergo AMI rehabilitation, and he is strongly considering the procedure. More than 2 million Americans are currently living with a lost limb, according to the Amputee Coalition, and nearly 200,000 lower legs are amputated each year in the United States.

On the robotics side, there are already commercial leg prosthetics that could be made compatible with the neural interface. The area in greatest need of development is the connection between amputation site and prosthesis. Herr says commercialization of that interface might be around five years away.

Herr says his long-term goal is neural integration and embodiment: the sense that a prosthetic is part of the body, rather than a tool. The new study “is a critical step forward—pun intended.”

Emteq Labs wants eyewear to be the next frontier of wearable health technology.

The Brighton, England-based company introduced today its emotion-sensing eyewear, Sense. The glasses contain nine optical sensors distributed across the rims that detect subtle changes in facial expression with more than 93 percent accuracy when paired with Emteq’s current software. “If your face moves, we can capture it,” says Steen Strand, whose appointment as Emteq’s new CEO was also announced today. With that detailed data, “you can really start to decode all kinds of things.” The continuous data could help people uncover patterns in their behavior and mood, similar to an activity or sleep tracker.

Emteq is now aiming to take its tech out of laboratory settings with real-world applications. The company is currently producing a small number of Sense glasses, and they’ll be available to commercial partners in December.

The announcement comes just weeks after Meta and Snap each unveiled augmented reality glasses that remain in development. These glasses are “far from ready,” says Strand, who led the augmented reality eyewear division while working at Snap from 2018 to 2022. “In the meantime, we can serve up lightweight eyewear that we believe can deliver some really cool health benefits.”

Fly Vision Vectors

While current augmented reality (AR) headsets have large battery packs to power the devices, glasses require a lightweight design. “Every little bit of power, every bit of weight, becomes critically important,” says Strand. The current version of Sense weighs 62 grams, slightly heavier than the Ray-Ban Meta smart glasses, which weigh in at about 50 grams.

Because of the weight constraints, Emteq couldn’t use the power-hungry cameras typically used in headsets. With cameras, motion is detected by looking at how pixels change between consecutive images. The method is effective, but captures a lot of redundant information and uses more power. The eyewear’s engineers instead opted for optical sensors that efficiently capture vectors when points on the face move due to the underlying muscles. These sensors were inspired by the efficiency of fly vision. “Flies are incredibly efficient at measuring motion,” says Emteq founder and CSO Charles Nduka. “That’s why you can’t swat the bloody things. They have a very high sample rate internally.”

Sense glasses can capture data as often as 6,000 times per second. The vector-based approach also adds a third dimension to a typical camera’s 2D view of pixels in a single plane.

These sensors look for activation of facial muscles, and the area around the eyes is an ideal spot. While it’s easy to suppress or force a smile, the upper half of our face tends to have more involuntary responses, explains Nduka, who also works as a plastic surgeon in the United Kingdom. However, the glasses can also collect information about the mouth by monitoring the cheek muscles that control jaw movements, conveniently located near the lower rim of a pair of glasses. The data collected is then transmitted from the glasses to pass through Emteq’s algorithms in order to translate the vector data into usable information.

In addition to interpreting facial expressions, Sense can be used to track food intake, an application discovered by accident when one of Emteq’s developers was wearing the glasses while eating breakfast. By monitoring jaw movement, the glasses detect when a user chews and how quickly they eat. Meanwhile, a downward-facing camera takes a photo to log the food, and uses a large language model to determine what’s in the photo, effectively making food logging a passive activity. Currently, Emteq is using an instance of OpenAI’s GPT-4 large language model to accomplish this, but the company has plans to create their own algorithm in the future. Other applications, including monitoring physical activity and posture, are also in development.

One Platform, Many Uses

Nduka believes Emteq’s glasses represent a “fundamental technology,” similar to how the accelerometer is used for a host of applications in smartphones, including managing screen orientation, tracking activity, and even revealing infrastructure damage.

Similarly, Emteq has chosen to develop the technology as a general facial data platform for a range of uses. “If we went deep on just one, it means that all the other opportunities that can be helped—especially some of those rarer use cases—they’d all be delayed,” says Nduka. For example, Nduka is passionate about developing a tool to help those with facial paralysis. But a specialized device for those patients would have high unit costs and be unaffordable for the target user. Allowing more companies to use Emteq’s intellectual property and algorithms will bring down cost.

In this buckshot approach, the general target for Sense’s potential use cases is health applications. “If you look at the history of wearables, health has been the primary driver,” says Strand. The same may be true for eyewear, and he says there’s potential for diet and emotional data to be “the next pillar of health” after sleep and physical activity.

How the data is delivered is still to be determined. In some applications, it could be used to provide real-time feedback—for instance, vibrating to remind the user to slow down eating. Or, it could be used by health professionals only to collect a week’s worth of at-home data for patients with mental health conditions, which Nduka notes largely lack objective measures. (As a medical device for treatment of diagnosed conditions, Sense would have to go through a more intensive regulatory process.) While some users are hungry for more data, others may require a “much more gentle, qualitative approach,” says Strand. Emteq plans to work with expert providers to appropriately package information for users.

Interpreting the data must be done with care, says Vivian Genaro Motti, an associate professor at George Mason University who leads the Human-Centric Design Lab. What expressions mean may vary based on cultural and demographic factors, and “we need to take into account that people sometimes respond to emotions in different ways,” Motti says. With little regulation of wearable devices, she says it’s also important to ensure privacy and protect user data. But Motti raises these concerns because there is a promising potential for the device. “If this is widespread, it’s important that we think carefully about the implications.”

Privacy is also a concern to Edward Savonov, a professor of electrical and computer engineering at the University of Alabama, who developed a similar device for dietary tracking in his lab. Having a camera mounted on Emteq’s glasses could pose issues, both for the privacy of those around a user and a user’s own personal information. Many people eat in front of their computer or cell phone, so sensitive data may be in view.

For technology like Sense to be adopted, Sazonov says questions about usability and privacy concerns must first be answered. “Eyewear-based technology has potential for a great future—if we get it right.”

Navigating the regulatory and ethical requirements of different medical data providers across many different countries, as well as safeguarding patient privacy, is a mammoth task that requires extra resources and expertise.  

The post AI is Revolutionizing Healthcare, But Are We Ready for the Ethical Challenges?  appeared first on MedCity News.

The vast majority of older adults want to age at home. To support that goal, doctors should encourage them to consider their care options — long before they need assistance.

The post Through Early Discussions About Elder Care, Doctors Can Empower Seniors to Age in Place appeared first on MedCity News.