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.

A Canada Border Services Agency superintendent is speaking out after being targeted by the Indian government with allegations of murder and terrorism — allegations Canadian authorities say are not backed by any evidence.

Les spectateurs québécois auront encore l’embarras du choix durant le temps des Fêtes.

Des Swifties québécoises racontent leur expérience durant un concert de la tournée «Eras».

Un premier spectacle d’humour en solo, intitulé «Après seulement 32 ans d’absence sur scène».

Le film québécois a devancé plusieurs grandes productions hollywoodiennes

ONE of the world’s most spectacular clouds made a dramatic entrance for passengers on an Adelaide-bound jet.

Small businesses say they deliberately avoid earning too much, to stop becoming liable for the sales tax and losing money.

Deputy PM admits former Soviet state was until recently a 'highly corrupt country' - but insists things are changing fast.

A court throws out a ruling that the gas and oil giant cut its greenhouse gas emissions.

A judge has issued a stinging rebuke to separating couples who expect the courts to decide frivolous disputes.

Nvision Biomedical Technologies and Invibio Biomaterial Solutions have announced that the FDA has granted clearance of the first 3D-Printed PEEK Interbody System made from PEEK-OPTIMA.

Global temperatures through September point to 2024 besting 2023 as the hottest year on record. How many future years set records depends in part on the outcome of the 2024 U.S. presidential election

The 2024 presidential election will have enormous consequences for the climate, and the health and future of children

The outcome of the 2024 U.S. presidential election could reshape policies from health care at home to nuclear proliferation abroad

People are really stressed about the U.S. presidential election. A psychiatrist offers several self-help methods to reduce feelings of despair

The outcome of the 2024 U.S. presidential election could set the climate agenda, reshape public education and shift the dynamics of global science collaboration.

Thousands of homes in Navajo and other tribal lands don’t have access to electricity. A $200-million federal funding effort aims to fix that problem with solar power and other clean energy

Several downballot races in the 2024 presidential election will carry implications for climate policy far beyond state lines

President-elect Trump vowed to promote fossil fuels, weaken pollution regulations and reverse Biden administration climate efforts

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

The new president-elect can go beyond just pulling out of the Paris Agreement. But it may be more difficult to roll back clean energy policies

The ACRO D&I Site Resource Grants Program aims to help sites acquire the resources and skills that will get them selected for studies and improve the reach of clinical research into underrepresented communities.

The post ACRO Announces Diversity and Inclusion Site Resource Grants Program first appeared on ACRO.

ACRO is pleased to announce the launch of the ACRO Diversity and Inclusion Site Resource Grants Program! The ACRO D&I Site Resource Grants Program aims to help sites acquire the resources and skills that will get them selected for studies and improve the reach of clinical research into underrepresented communities. “We are excited to invite […]

The post ACRO Announces Diversity and Inclusion Site Resource Grants Program first appeared on ACRO.

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.

The proposed American Privacy Rights Act (APRA) has taken its first step U.S. House legislative process with several issue disagreements becoming more evident. On May 23, the U.S. House Committee on Energy and Commerce Subcommittee on Data, Innovation and Commerce approved the updated APRA, advancing the bill to full committee consideration. Just prior to the […]

Early in the pandemic there was a widespread belief that science would be our salvation. With the help of science we would be spared the worst consequences, such as occurred during the 1918 Spanish flu pandemic. A vaccine would arrive, reliably, after a few hard months of research, and in short order the problem would...

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The UK’s first postal inhaler recycling scheme has been launched by pharmaceutical company Chiesi to support a more sustainable way of living for people with respiratory illnesses.

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.

Today’s market likes products. Platforms aren’t in vogue anymore. Investors, especially in the public markets, only want late stage de-risked assets. Pharma only seems to be buying these kinds of asset. VCs need to focus on clinical stage companies. Or

The post Biotech Risk Cycles: Assets And Platforms 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.]

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]}

Participant reported relief from chronic low back pain and reduced need for pain-relief medications.

By adopting a contingent workforce model and investing in the right data tools to power better informed decision-making and talent strategy, healthcare organizations can begin to address staffing challenges and turn their talent goals into reality. 

The post Closing Staffing Gaps in Healthcare by Utilizing Diverse Pipelines of Contingent Talent appeared first on MedCity News.

In vitro diagnostics (IVDs) play an indispensable role in modern medicine. Health care providers routinely rely on these tests—which analyze samples such as blood or saliva—to help diagnose conditions and guide potentially life-altering treatment decisions. In 2017, for example, clinicians ordered blood tests during about 45% of emergency room visits in the United States, according to the Centers...

Life can sometimes feel like a never-ending cycle of stress and decisions. That's usually my weekdays in a nutshell: chasing deadlines, making tough calls, and hopping between meetings. When your brain feels like it's on overdrive, it's time to hit pause. Engaging in some therapeutic activities can give your mind the breather it desperately needs. The good news? They don't have to be complicated or time-consuming. Here are some that can work wonders for your mental clarity and overall well-being. Step outside for a walk Walking is one of the simplest ways to clear your mind. It's amazing what a little fresh air at your nearby PCN can do. Just stepping outside and getting those legs moving can shift your perspective in a matter of minutes — and burn a few calories too! Disconnect from your phone and enjoy the sights and sounds of the great outdoors. I find that a 30-min walk and a change of environment works wonders for me, helping me rationally dissect my worries, such as my crushing feelings of inadequacy at work.

SINGAPORE — On more than 460 occasions, a man forged Grab receipts and sent them to his company, causing the firm to disburse over $16,400 to him. He also made false medical certificates and an electronic letter purportedly from the Singapore Armed Forces, causing the Ministry of Health (MOH), where he worked as a temporary staff, to excuse him from reporting for work. On Nov 12, Muhammad Fariz Shaik Sha Marican, 33, pleaded guilty to two forgery charges. Two other similar charges will be taken into consideration during sentencing. Deputy Public Prosecutor Kelly Ng said that Fariz was employed by recruitment firm Persolkelly (PSK), which worked with MOH to provide manpower. Fariz was deployed by PSK in November 2021 to work as a temporary staff for MOH to support the ministry's Covid-19 operations. In April 2023, MOH checked on Fariz's annual leave balance as the ministry wanted to convert him into a staff member.

SINGAPORE - When an online retailer began selling his products on e-commerce platform Qoo10 in August 2023, he did not bat an eyelid when it took 30 to 45 days for the platform to disburse his first payout, compared with about three to seven days for other e-commerce sites he was using. But nearly a year later in July, payments owed to his business by Qoo10 had ballooned to about $1.6 million, as the platform’s payment delays exceeded two months and disbursements began trickling in, in smaller amounts. The Singaporean, who wanted to be known only as Mr T and did not wish to divulge what he sold, pulled the plug on his Qoo10 shop this year in the middle of July, and filed a civil claim with the courts. He obtained a default judgment in October for Qoo10 to pay him what he is owed, after the e-commerce site failed to serve a notice of intention to contest or not contest the claim. Mr T, who added that he had borrowed nearly $1 million from banks, friends and relatives to pay his suppliers, said: “I am not holding out hope that I will get much, or any, of my money back from Qoo10... By this point, I just want closure because it’s been so stressful.”

JAKARTA — Indonesia said on Monday (Nov 11) it does not recognise China's claims over the South China Sea despite signing a joint maritime development deal with Beijing, as some analysts warned the agreement risked compromising the country's sovereign rights. Beijing has long clashed with its Southeast Asian neighbours over territory in the South China Sea, which it claims sovereignty over in almost its entirety via a "nine-dash line" on its maps that cuts into the exclusive economic zones (EEZ) of several countries. Joint agreements with China in the strategic waterway have for years been sensitive, with some claimant states wary of entering into deals they fear could be interpreted as legitimising Beijing's vast claims. An arbitral tribunal in 2016 said the Chinese claim, based on its old maps, has no basis under international law, a decision China refuses to recognise. A joint statement issued at the weekend during Indonesian President Prabowo Subianto's visit to Beijing mentioned the two countries had "reached important common understanding on joint development in areas of overlapping claims".

CANBERRA — China is putting ever-greater pressure on the Philippines to cede its sovereign rights in the South China Sea, Secretary of National Defence Gilberto Teodoro said on Nov 12 after a meeting with his Australian counterpart in Canberra. "What we see is an increasing demand by Beijing for us to concede our sovereign rights in the area," he said, adding that the Philippines was a "victim of Chinese aggression". China and the Philippines have sparred repeatedly this year over disputed areas of the South China Sea, including the Scarborough Shoal, one of Asia's most contested features. Teodoro's meeting with his Australian counterpart Richard Marles, their fifth since August 2023, reflects growing security ties between the countries, both of whom have expressed concern about Chinese activity in areas of the South China Sea claimed by the Philippines and other Southeast Asian nations. The two nations signed a strategic partnership in September 2023 and held their first joint sea and air patrols in the South China Sea several months later. The Philippines also joined war games in Australia this year for the first time.