06/02/2026  |  Jenna Kurtzweil  |  UIC Today

https://today.uic.edu/clinical-trials-for-alzheimers-drugs-omit-key-populations/ 

Racial and ethnic groups most at risk for Alzheimer’s disease are underrepresented in U.S. clinical trials, according to UIC research.

Zhuoer Lin, an assistant professor in the School of Public Health, led a study analyzing patient populations in U.S. clinical trials for Alzheimer’s treatments. He found that almost half of the trials did not report on race or ethnicity at all, and of those that did, more than 90% of participants identified as white. Comparatively few patients identified as Black, Hispanic, Native American and Asian or Pacific Islander.

Such a gap limits researchers’ understanding of how new treatments affect underrepresented populations, many of whom have a higher risk, statistically, for Alzheimer’s disease than white older adults do. Compared to white older adults, Black older adults are twice as likely to develop the neurodegenerative disease. For Hispanic older adults, the risk is 1.5 times more.

“Especially in a country as diverse as the U.S., clinical trials need to represent all populations,” Lin said.

Lin and his colleagues looked at 71 clinical trials for Alzheimer’s disease treatments conducted in the U.S. between 1997 and 2023. All were Phase 3 clinical trials: the final level of drug testing before FDA approval.

The researchers scanned the trials for any reporting on participants’ race and ethnicity, including the language used to describe participants’ race and ethnicity and whether any critical discussion was included (for example, if the report acknowledged any inequities present).

Of the 36 trials that did report on participants’ race or ethnicity, that reporting…

06/01/2026  |  Gareth Macdonald  |  BioXconomy

https://www.bioxconomy.com/clinical-and-research/faster-approvals-only-half-the-battle-eu-trials-need-adaptive-protocols- 

Streamlined approvals alone won't fix Europe's clinical trial challenges, researchers say, pointing to enrollment problems and inflexible study designs.

Faster approvals only half the battle: Adaptive protocol would aid EU trials sector

Streamlined trial approvals would only solve one of the challenges firms face when testing drugs in Europe, say the authors of a study, who argue that operational issues like poor enrollment and rigid protocols are a bigger problem.

The study—published in Clinical Microbiology and Infection—shows that while initiatives like Accelerating Clinical Trials in the European Union (ACT-EU) are a positive move, there are other issues to be addressed.

“Even when hurdles in trial initiation are overcome, challenges remain: up to one-third of clinical trials are terminated prematurely, primarily due to operational issues such as poor enrolment. 

“It is a serious issue when valuable public resources are used for well-designed trials addressing important research questions, only for those to fail to deliver results,” they wrote.

Adaptive trials
Flexibility, or the lack thereof, is another challenge for Europe’s trials sector, according to the authors, who suggest greater regulatory support for adaptive protocols—that evolve while the study is ongoing—would be beneficial.

“As more trials adopt flexible structures to accommodate change, this represents a paradigm shift: rather than developing a new trial for each new research question, adaptive…

06/02/2026  |  Moe Alsumidaie  |  The Clinical Trial Vanguard

https://www.clinicaltrialvanguard.com/opinion/decentralized-trials-are-everywhere-nobody-agrees-what-theyre-for/ 

Pick up any clinical development conference agenda from the last two years and a pattern emerges: decentralized clinical trials get their own keynote slot, their own breakout session, their own pre-conference workshop. Platform vendors have multiplied. CROs have built dedicated DCT service lines. Pfizer’s public statements have credited remote elements with accelerating COVID-19 vaccine trial logistics. The FDA issued a final guidance on conducting clinical trials with decentralized elements in September 2024, lending the whole enterprise institutional gravity. By almost every surface-level measure, decentralized trials have arrived.

The data can be made to look compelling. According to research from the Tufts Center for the Study of Drug Development’s PACT Consortium, DCT-enabled trials enrolled Asian participants at a rate of 20.9% compared to 14.2% in traditional trials, and American Indian or Alaska Native participation reached 1.9% — nearly four times the 0.5% seen in conventional designs. Those numbers get cited in investor decks, regulatory submissions, and op-eds. They are real. They are also cherry-picked from trials where DCT elements were carefully selected, well-resourced, and operationally compatible with the patient population in question.

Yet underneath the momentum, there is no shared understanding of what decentralized trials are actually supposed to accomplish — and when the stakeholders who must execute them want genuinely incompatible things, the model does not quietly underperform. It collapses.

The Stakeholders Are Not Pulling the Same Direction Read more... Read less... Open