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A PrEP trial of epic proportions

On World AIDS Day last year, the NSW Government announced an expansion of a trial to make PrEP available to 3700 people in the state. Known as EPIC NSW, it is expected to reduce new HIV diagnoses by 50 per cent or more in two years. Matthew Wade found out more.

The post A PrEP trial of epic proportions appeared first on Star Observer.




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LGBTI people can get a free breast screen with BreastScreen Victoria

This Thursday and Saturday, BreastScreen Victoria is providing free LGBTI specific mammogram sessions to women and trans and gender diverse people over the age of 40, as part of their ...

The post LGBTI people can get a free breast screen with BreastScreen Victoria appeared first on Star Observer.




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Enlevée par ses frères dans un resto: «Elle criait d’appeler le 911»

Une ado qui aurait été enlevée de force par ses propres frères était en panique et criait d’appeler le 911, selon un témoin appelé au procès.




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Time limits for trials were meant to speed up justice. They've also halted hundreds of criminal cases

Supporters say the Supreme Court of Canada's so-called Jordan ruling in 2016 has sped up proceedings and strengthened Charter rights for prompt justice. But some victims say the time limits for trials work in criminals' favour and cases continue to collapse because those limits are breached. 



  • News/Canada/British Columbia

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'Keep trying. Dream': The life and message of Murray Sinclair honoured at memorial service

The family of the late Murray Sinclair remember his life as they are joined by members of the public, the Canadian Governor General and prime minister during a commemorative service at Winnipeg's Canada Life Centre to honour his legacy Sunday afternoon.



  • News/Canada/Manitoba

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Toboggan 2024: La Bottine Souriante et MATTN défonceront l’année à Québec

La ville de Québec pourra compter sur des prestations du groupe La Bottine Souriante et de la DJ belge MATTN pour l’amener en 2025.




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NABL to usher in accreditation insights for reference material producers in Raipur and Hyderabad

Two exclusive conferences focusing on "Reference Material (RM) Producers" organized by National Accreditation Board for Testing and Calibration Laboratories (NABL) are scheduled to be held on January 10,




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Inter─ministerial committee calls for amendment in FSSAI Act on nutraceuticals

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




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Bacteria Tag Team Tumors with T Cells

A team at Columbia University School of Engineering and Applied Science has developed a technique to enhance chimeric antigen receptor (CAR) T cell therapy in solid tumors. The technique involves engineering E. coli bacteria, that naturally tend to accumulate in the immune privileged core of solid tumors. The bacteria have been engineered to interact with […]




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Magnetoelectric Material Stimulates Neurons Minimally Invasively

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 […]




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NPRA Malaysia trials new timelines for variation applications

<p>In May 2024, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) announced that it will trial new timelines for variation applications&nbsp;of registered pharmaceutical products and natural health supplements (TMHS).</p>




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Everything you need to know about the COVID-19 therapy trials

Researchers around the world are working at record speed to find the best ways to treat and prevent COVID-19, from investigating the possibility of repurposing existing drugs to searching for novel therapies against the virus.




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Mariana Oncology’s Radiopharm Platform Acquired By Novartis

Novartis recently announced the acquisition of Mariana Oncology, an emerging biotech focused on advancing a radioligand therapeutics platform, for up to $1.75 billion in upfronts and future milestones. The capstone of its three short years of operations, this acquisition represents

The post Mariana Oncology’s Radiopharm Platform Acquired By Novartis appeared first on LifeSciVC.




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Tell the UK’s research regulator to do more on clinical trial transparency

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 […]




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UK universities and NHS trusts that flout the rules on clinical trials identified in report to Parliament

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 […]




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AllTrials guide to asking academic institutions about missing results

When university and hospital trusts were called to the UK parliament last year to answer questions on why they were not following the rules on reporting results, we saw how effective the questioning from politicians was. Those of you who watched the parliamentary session saw the pressure the university representatives were put under. Because the politicians asked […]




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Half of US clinical trials are breaking the law on reporting results

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 […]




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Hundreds of clinical trials ruled to be breaking the law

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 […]




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Clinical Trial Enrollment, ASCO 2013 Edition

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.”


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.


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?



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



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.]




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Pediatric Trial Enrollment (Shameless DIA Self-Promotion, Part 1)


[Fair Warning: I have generally tried to keep this blog separate from my corporate existence, but am making an exception for two quick posts about the upcoming DIA 2013 Annual Meeting.]

Improving Enrollment in Pediatric Clinical Trials


Logistically, ethically, and emotionally, involving children in medical research is greatly different from the same research in adults. Some of the toughest clinical trials I've worked on, across a number of therapeutic areas, have been pediatric ones. They challenge you to come up with different approaches to introducing and explaining clinical research – approaches that have to work for doctors, kids, and parents simultaneously.

On Thursday June 27, Don Sickler, one of my team members, will be chairing a session titled “Parents as Partners: Engaging Caregivers for Pediatric Trials”. It should be a good session.

Joining Don are 2 people I've had the pleasure of working with in the past. Both of them combine strong knowledge of clinical research with a massive amount of positive energy and enthusiasm (no doubt a big part of what makes them successful).

However, they also differ in one key aspect: what they work on. One of them – Tristen Moors from Hyperion Therapeutics - works on an ultra-rare condition, Urea Cycle Disorder, a disease affecting only a few hundred children every year. On the other hand, Dr. Ann Edmunds is an ENT working in a thriving private practice. I met her because she was consistently the top enroller in a number of trials relating to tympanostomy tube insertion. Surgery to place “t-tubes” is one of the most common and routine outpatients surgeries there is, with an estimated half million kids getting tubes each year.

Each presents a special challenge: for rare conditions, how do you even find enough patients? For routine procedures, how do you convince parents to complicate their (and their children’s) lives by signing up for a multi-visit, multi-procedure trial?

Ann and Tristen have spent a lot of time tackling these issues, and should have some great advice to give.

For more information on the session, here’s Don’s posting on our news blog.




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Counterfeit Drugs in Clinical Trials?

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."

[Emphasis added.]

I have to admit to being a little floored by the idea that there is any sort of risk, in industry-run clinical trials, of counterfeit medication "infiltration".

Does Gill know something that the rest of us don't? Or is this just an awkward slap at perceived competition – innuendo against the companies that currently manage clinical trial comparator drug supply? Or an attempt at depicting the trials of non-Transcelerate members as risky and prone to fraud?

Either way, it could use some explaining. Thinking I might have missed something, I did do a quick literature search to see if I could come across any references to counterfeits in trials. Google Scholar and PubMed produced no useful results, but Wikipedia helpfully noted in its entry on counterfeit medications:

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


And on that point, I think we can agree: Citation needed. I hope the folks at Transcelerate will oblige.




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Half of All Trials Unpublished*

(*For certain possibly nonstandard uses of the word "unpublished")

This is an odd little study. Instead of looking at registered trials and following them through to publication, this study starts with a random sample of phase 3 and 4 drug trials that already had results posted on ClinicalTrials.gov - so in one, very obvious sense, none of the trials in this study went unpublished.

Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals
Carolina Riveros, Agnes Dechartres, Elodie Perrodeau, Romana Haneef, Isabelle Boutron, Philippe Ravaud



But here the authors are concerned with publication in medical journals, and they were only able to locate journal articles covering about half (297/594) of trials with registered results. 

It's hard to know what to make of these results, exactly. Some of the "missing" trials may be published in the future (a possibility the authors acknowledge), some may have been rejected by one or more journals (FDAAA requires posting the results to ClinicalTrials.gov, but it certainly doesn't require journals to accept trial reports), and some may be pre-FDAAA trials that sponsors have retroactively added to ClinicalTrials.gov even though development on the drug has ceased.

It would have been helpful had the authors reported journal publication rates stratified by the year the trials completed - this would have at least given us some hints regarding the above. More than anything I still find it absolutely bizarre that in a study this small, the entire dataset is not published for review.

One potential concern is the search methodology used by the authors to match posted and published trials. If the easy routes (link to article already provided in ClinicalTrials.gov, or NCT number found in a PubMed search) failed, a manual search was performed:
The articles identified through the search had to match the corresponding trial in terms of the information registered at ClinicalTrials.gov (i.e., same objective, same sample size, same primary outcome, same location, same responsible party, same trial phase, and same sponsor) and had to present results for the primary outcome. 
So it appears that a reviewed had to score the journal article as an exact match on 8 criteria in order for the trial to be considered the same. That could easily lead to exclusion of journal articles on the basis of very insubstantial differences. The authors provide no detail on this; and again, that would be easy to verify if the study dataset was published. 

The reason I harp on this, and worry about the matching methodology, is that two of the authors of this study were also involved in a methodologically opaque and flawed study about clinical trial results posted in the JCO. In that study, as well, the authors appeared to use an incorrect methodology to identify published clinical trials. When I pointed the issues out, the corresponding author merely reiterated what was already (insufficiently) in the paper's Methodology section.

I find it strange beyond belief, and more than a little hypocritical, that researchers would use a public, taxpayer-funded database as the basis of their studies, and yet refuse to provide their data for public review. There are no technological or logistical issues preventing this kind of sharing, and there is an obvious ethical point in favor of transparency.

But if the authors are reasonably close to correct in their results, I'm not sure what to make of this study. 

The Nature article covering this study contend that
[T]he [ClinicalTrials.gov] database was never meant to replace journal publications, which often contain longer descriptions of methods and results and are the basis for big reviews of research on a given drug.
I suppose that some journal articles have better methodology sections, although this is far from universally true (and, like this study here, these methods are often quite opaquely described and don't support replication). As for results, I don't believe that's the case. In this study, the opposite was true: ClinicalTrial.gov results were generally more complete than journal results. And I have no idea why the registry wouldn't surpass journals as a more reliable and complete source of information for "big reviews".

Perhaps it is a function of my love of getting my hands dirty digging into the data, but if we are witnessing a turning point where journal articles take a distant back seat to the ClinicalTrials.gov registry, I'm enthused. ClinicalTrials.gov is public, free, and contains structured data; journal articles are expensive, unparsable, and generally written in painfully unclear language. To me, there's really no contest. 

Carolina Riveros, Agnes Dechartres, Elodie Perrodeau, Romana Haneef, Isabelle Boutron, & Philippe Ravaud (2013). Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals PLoS Medicine DOI: 10.1371/journal.pmed.1001566




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Patient Centered Trials - Your Thoughts Needed

The good folks down at eyeforpharma have asked me to write a few blog posts in the run-up to their Patient Centered Clinical Trials conference in Boston this September. In my second article -Buzzword Innovation: The Patient Centricity “Fad” and the Token Patient - I went over some concerns I have regarding the sudden burst of enthusiasm for patient centricity in the clinical trial world.

Apparently, that hit a nerve – in an email, Ulrich Neumann tells me that “your last post elicited quite a few responses in my inbox (varied, some denouncing it as a fad, others strongly protesting the notion, hailing it as the future).”

In preparing my follow up post, I’ve spoken to a couple people on the leading edge of patient engagement:


In addition to their thoughts, eyeforpharma is keenly interested in hearing from more people. They've even posted a survey – from Ulrich:
To get a better idea of what other folks think of the idea, I am sending out a little ad hoc survey. Only 4 questions (so people hopefully do it). Added benefit: There is a massive 50% one-time discount for completed surveys until Friday connected to it as an incentive).
So, here are two things for you to do:

  1. Complete the survey and share your thoughts
  2. Come to the conference and tell us all exactly what you think

Look forward to seeing you there.

[Conflict of Interest Disclosure: I am attending the Patient Centered Clinical Trials conference. Having everyone saying the same thing at such conferences conflicts with my ability to find them interesting.]





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Will Your Family Make You a Better Trial Participant?

It is becoming increasing accepted within the research community that patient engagement leads to a host of positive outcomes – most importantly (at least practically speaking) improved clinical trial recruitment and retention.

But while we can all agree that "patient engagement is good" in a highly general sense, we don't have much consensus on what the implications of that idea might be. There is precious little hard evidence about how to either attract engaged patients, or how we might effectively turn "regular patients" into "engaged patients".

That latter point - that we could improve trial enrollment and completion rates by converting the (very large) pool of less-engaged patient - is a central tenet of the mHealth movement in clinical trials. Since technology can now accompany us almost anywhere, it would seem that we have an unprecedented opportunity to reach out and connect with current and potential trial participants.

However, there are signs that this promised revolution in patient engagement hasn't come about. From the decline of new apps being downloaded to the startlingly high rate of people abandoning their wearable health devices, there's a growing body of evidence suggesting that we aren't in fact making very good progress towards increasing engagement. We appear to have underestimated the inertia of the disengaged patient.

So what can we do? We know people like their technology, but if they're not using it to engage with their healthcare decisions, we're no better off as a result.

Daniel Calvert, in a recent blog post at Parallel 6 offers an intriguing solution: he suggests we go beyond the patient and engage their wider group of loved ones. By engaging what Calvert calls the Support Circle - those people most likely to "encourage the health and well being of that patient as they undergo a difficult period of their life" - trial teams will find themselves with a more supported, and therefore more engaged, participant, with corresponding benefits to enrollment and retention. 

Calvert outlines a number of potential mechanisms to get spouses, children, and other loved ones involved in the trial process:
During the consent process the patient can invite their support team in with them. A mobile application can be put on their phones enabling encouraging messages, emails, and texts to be sent. Loved ones can see if their companion or family member did indeed take today’s medication or make last Monday’s appointment. Gamification offers badges or pop-ups: “Two months of consecutive appointments attended” or “perfect eDiary log!” Loved ones can see those notifications, like/comment, and constantly encourage the patients. 
Supporting materials can also be included in the Support Circle application. There are a host of unknown terms to patients and their team. Glossaries, videos, FAQs, contact now, and so much more can be made available at their fingertips.
I have to admit I'm fascinated by Calvert's idea. I want him to be right: the picture of supportive, encouraging, loving spouses and children standing by to help a patient get through a clinical trial is an attractive one. So is the idea that they're just waiting for us to include them - all we need to do is a bit of digital communication with them to get them fully on board as members of the study team.

The problem, however, remains: we have absolutely no evidence that this approach will work. There is no data showing that it is superior to other approaches to engage trial patients.

(In fact, we may even have some indirect evidence that it may hinder enrollment: in trials that require active caregiver participation, such as those in Alzheimer's Disease, caregivers are believed to often contribute to the barriers to patient enrollment).

Calvert's idea is a good one, and it's worthy of consideration. More importantly, it's worthy of being rigorously tested against other recruitment and retention approaches. We have a lot of cool new technologies, and even more great ideas - we're not lacking for those. What we're lacking is hard data showing us how these things perform. What we especially need is comparative data showing how new tactics work relative to other approaches.

Over 5 years ago, I wrote a blog post bemoaning the sloppy approaches we take in trial recruitment - a fact made all the more painfully ironic by the massive intellectual rigor of the trials themselves. I'm not at all sure that we've made any real progress in those 5 years.

In my next post, I'll outline what I believe are some of the critical steps we need to take to improve the current situation, and start bringing some solid evidence to the table along with our ideas.

[Photo credit: Flikr user Matthew G, "Love (of technology)"]







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REMOTE Redux: DTP trials are still hard

Maybe those pesky sites are good for something after all. 

It's been six years since Pfizer boldly announced the launch of its "clinical trial in a box". The REMOTE trial was designed to be entirely online, and involved no research sites: study information and consent was delivered via the web, and medications and diaries were shipped directly to patients' homes.

Despite the initial fanfare, within a month REMOTE's registration on ClinicalTrials.gov was quietly reduced from 600 to 283. The smaller trial ended not with a bang but a whimper, having randomized only 18 patients in over a year of recruiting.

Still, the allure of direct to patient clinical trials remains strong, due to a confluence of two factors. First, a frenzy of interest in running "patient centric clinical trials". Sponsors are scrambling to show they are doing something – anything – to show they have shifted to a patient-centered mindset. We cannot seem to agree what this means (as a great illustration of this, a recent article in Forbes on "How Patients Are Changing Clinical Trials" contained no specific examples of actual trials that had been changed by patients), but running a trial that directly engages patients wherever they are seems like it could work.

The less-openly-discussed other factor leading to interest in these DIY trials is sponsors' continuing willingness to heap almost all of the blame for slow-moving studies onto their research sites. If it’s all the sites’ fault – the reasoning goes – then cutting them out of the process should result in trials that are both faster and cheaper. (There are reasons to be skeptical about this, as I have discussed in the past, but the desire to drop all those pesky sites is palpable.)

However, while a few proof-of-concept studies have been done, there really doesn't seem to have been another trial to attempt a full-blown direct-to-patient clinical trial. Other pilots have been more successful, but had fairly lightweight protocols. For all its problems, REMOTE was a seriously ambitious project that attempted to package a full-blown interventional clinical trial, not an observational study.

In this context, it's great to see published results of the TAPIR Trial in vasculitis, which as far as I can tell is the first real attempt to run a DIY trial of a similar magnitude to REMOTE.

TAPIR was actually two parallel trials, identical in every respect except for their sites: one trial used a traditional group of 8 sites, while the other was virtual and recruited patients from anywhere in the country. So this was a real-time, head-to-head assessment of site performance.

And the results after a full two years of active enrollment?

  • Traditional sites: 49 enrolled
  • Patient centric: 10 enrolled
Even though we’re six years later, and online/mobile communications are even more ubiquitous, we still see the exact same struggle to enroll patients.

Maybe it’s time to stop blaming the sites? To be fair, they didn’t exactly set the world on fire – and I’m guessing the total cost of activating the 8 sites significantly exceeded the costs of setting up the virtual recruitment and patient logistics. But still, the site-less, “patient centric” approach once again came up astonishingly short.


Krischer J, Cronholm PF, Burroughs C, McAlear CA, Borchin R, Easley E, Davis T, Kullman J, Carette S, Khalidi N, Koening C, Langford CA, Monach P, Moreland L, Pagnoux C, Specks U, Sreih AG, Ytterberg S, Merkel PA, & Vasculitis Clinical Research Consortium. (2017). Experience With Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study. Journal of medical Internet research, 19 (2) PMID: 28246067




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‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer

Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability.

The post ‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer appeared first on MedCity News.




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Tools to Boost Beneficial Bacteria Can Help Poultry Farms Fight Salmonella

Chicken products cause an estimated 1 in 7 of the nation’s human Salmonella illnesses each year, partly because the pathogen can easily contaminate the environments where birds are raised. To reduce the risk that contaminated meat will reach consumers, poultry companies need measures that control the bacterium on farms where chickens are bred and raised.




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Trump's Day One: Deportations, border wall, scrapping Biden humanitarian programs

WASHINGTON — Donald Trump is expected to take a slew of executive actions on his first day as president to ramp up immigration enforcement and roll back signature Biden legal entry programs, a sweeping effort that will be led by incoming "border czar" Tom Homan and other Republican immigration hardliners, three sources familiar with the matter told Reuters. The executive actions would give federal immigration officers more latitude to arrest people with no criminal records, surge troops to the US-Mexico border and restart construction of the border wall, the sources said. Homan, who served as acting director of US Immigration and Customs Enforcement from 2017-2018 under Trump, will bring a deep understanding of the US immigration system after a four-decade career that took him from a frontline Border Patrol agent to head of the agency that arrests and deports immigrants in the US illegally.




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Trial starts over rape, murder of junior doctor in India's Kolkata

KOLKATA — A court in the eastern state of West Bengal began the trial on Monday (Nov 11) of a police volunteer accused of raping and murdering a doctor at a government hospital in August, a case that sparked outrage over the lack of safety for women in India. The woman's body was found in a classroom at the R.G. Kar Medical College and Hospital in the state capital Kolkata on Aug 9, the federal police said. They also said they had arrested a police volunteer, Sanjay Roy, for the crime.




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Rep. Mike McCaul and Amb. Paula J. Dobriansky on Competing with China and Russia

House Foreign Affairs Committee Ranking Member Mike McCaul (R-TX) and Ambassador Paula J. Dobriansky spoke about how the U.S. can better compete against China and Russia on technology and supply chains. Other topics included making changes to improve the defense industrial base, protecting critical supply chain infrastructure, and preparedness for major events like a pandemic.




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The Faultlines Podcast: A Conversation with Ambassador Paula J. Dobriansky

A conversation hosted by the Faultlines Podcast with Ambassador Paula J. Dobriansky covering her career at the U.S. State Department and current geopolitical issues like the Russia-China strategic alignment.




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Who Supports Gender Quotas in Transitioning and Authoritarian States in the Middle East and North Africa?

What are the drivers of citizens’ support for electoral gender quotas in transitioning and authoritarian states? Despite extensive research examining public support for women in politics in democracies, we know little about how the public perceives them in less democratic settings. To address this shortcoming, we use original survey data from authoritarian Morocco and transitioning Tunisia – two Arab countries hailed for their progressive gender policies. We argue that in these countries where citizens lack political information, they instead rely on their assessment of the government’s performance to form attitudes toward gender quotas. Furthermore, electoral legitimacy plays an important role in shaping citizens’ support for quotas, which are closely linked to how elections and legislatures operate. The findings offer strong support for our theoretical expectations and uncover important gender differences.








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Global Players: The Role of International Humanitarian Organizations in Africa

On April 2, the study group met for the second time to evaluate the role of international humanitarian groups in shaping political and social outcomes in Africa. The group examined how these organizations deal with emergencies, crises, and conflict situations across the continent, and scrutinized their influence on policy decisions and discuss the potential benefits and drawbacks of their involvement. Discussions covered the expanding influence of organizations like the United Nations High Commissioner for Refugees (UNHCR), Médecins Sans Frontières (Doctors Without Borders), and the International Rescue Committee (ICR). The study group counted with the presence of external expert guest Professor Sabs K. Quereshi, a senior-level leader with 17+ years of experience in global health, gender equality, health policy and equity, national security, humanitarian response, and government and multilateral affairs sectors in the U.S., with the UN, and worldwide.




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Remembering Memorial Day: We Must Avoid World War III

We must avoid the successor to the grand reapers of the past century: World War I and World War II. We must avoid World War III. We should reflect on this during this Memorial Day.




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State Farm� Teams Up with Canine Expert Victoria Stilwell to Take a Bite Out of Dog Attacks - Video OneTitle

National Dog Bite Prevention Week is May 18-24. Any dog can bite, regardless of breed. Be a responsible pet owner.




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TEXAS TROCAS regresa con nuevas historias, más camiones y transformaciones aún más extremas - Vídeo 1

La segunda temporada de Texas Trocas llega a Discovery en Español con nuevas historias y transformaciones aún más extremas.




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Brian Custer Teams Up with the Prostate Cancer Foundation to Urge Men to "Man Up and Get Checked" - Man Up and Get Checked

Prostate Cancer Foundation, Evander Holyfield and Brian Custer encourage African-American men to �man up and get checked� for prostate cancer.




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Supergoop! Co-Owner Maria Sharapova and Founder & CEO Holly Thaggard Announce the Launch of Project Black Dot - Call to Action: Project Permission

Sunscreen is FDA regulated as an over the counter drug and thus restricted from schools, playgrounds & practice fields. Give your child the right to bring sunscreen to school with a simple permission slip.




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"Only" Stand and Wait- A Memorial for Annie Glenn

Think you know who the most accomplished American in history is? I bet you don't. She just passed, and this year for Memorial Day we take a serious moment to remember her.




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Who Is Kevin Federline’s Wife? Victoria Prince’s Job & Relationship History

Kevin Federline is a popular disk jockey, dancer, and actor, arguably best known for his first marriage to pop star Britney Spears. As a dancer, he has worked with the likes of Michael Jackson, Justin Timberlake, and Pink. He also appeared alongside Spears on a reality TV series called Britney and Kevin: Chaotic. But, Federline […]

The post Who Is Kevin Federline’s Wife? Victoria Prince’s Job & Relationship History appeared first on ComingSoon.net - Movie Trailers, TV & Streaming News, and More.




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Save the Children in Gaza: Israel Bombs Polio Vax Site, Bans UNRWA in Attacks on Humanitarian Aid

As Israel continues to block lifesaving humanitarian aid from entering northern Gaza, humanitarian organizations are describing its siege as “apocalyptic” and warning of mass Palestinian starvation and death. “The situation is absolutely desperate,” says Rachael Cummings of the aid group Save the Children International. Cummings joins us from Deir al-Balah in central Gaza, where aid organizations have been halted from entering the north. She responds to news of Israel’s bombing of a polio vaccination center in an area that had been marked for an official humanitarian pause, and the Knesset’s vote to ban the U.N. relief agency UNRWA.




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"The Misinformation Web": Maria Hinojosa on the Pro-Trump Propaganda Targeting Latinos in 2024

As Latino voters are a key voting bloc in the 2024 presidential election in battleground states like Nevada, Arizona and Pennsylvania, they have been targeted by a rise in Spanish-language misinformation. Most of the false messaging disparages Kamala Harris and supports Donald Trump, says Pulitzer Prize-winning journalist Maria Hinojosa, host of Latino USA, which investigated the phenomenon in a new episode called “The Misinformation Web.” She interviewed some of the content creators in this “blob” of online vitriol and says there is almost no effective content moderation online, nor many reliable fact-checking sources in Spanish to counter the lies.




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End the Arms: Humanitarian Chief Jan Egeland Urges U.S. to Stop Arming Israel Before Trump Takes Office

Top U.N. officials are again warning that the entire Palestinian population in north Gaza is “at imminent risk of dying from disease, famine and violence.” At least 1,800 Palestinians have been killed, many of them children, since October, when Israel imposed a draconian siege and began an intensified campaign of ethnic cleansing on northern Gaza. Jan Egeland of the Norwegian Refugee Council recently spent several days in Gaza. He describes what he saw as “devastation beyond belief,” as Palestinians face “the most intense and most indiscriminate bombardment anywhere in the world in recent memory,” coupled with the utter depletion of aid. Egeland pleads for the United States, the largest supplier of military funding and equipment to Israel, to condition its weapons to Israel, enforce the provision of aid and commit to ending Israel’s assault. “It’s not in Israel’s interest to destroy its neighborhood in Gaza and in Lebanon. It will create new generations of hatred,” Egeland says.




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The Industrial Designer behind the N95 Mask

Sara Little Turnbull used materials science to invent and design products for the modern world