A $240,000 bet on diversifying neuropsychiatry clinical trials

Clinical trials in neuropsychiatry have a representation problem. Studies of Alzheimer's disease, Parkinson's, schizophrenia, ALS, and multiple sclerosis consistently enroll populations that don't reflect the communities most affected by these conditions. Black and Hispanic patients remain underrepresented in dementia research despite bearing a disproportionate burden of the disease. Recruitment in schizophrenia trials skews heavily toward institutional settings that miss large segments of the population.

These gaps aren't just ethical concerns. They produce science that may not generalize to the patients who need it most.

A training program born from oncology's diversity crisis

The Robert A. Winn Career Development Award was created in 2020 by the Bristol Myers Squibb Foundation with a focused mission: train a new generation of clinical trialists who would prioritize community engagement and representative enrollment. Named after Robert A. Winn, a leader in cancer health equity, the program initially targeted oncology, where the underrepresentation of minority patients in drug trials had long been documented but inadequately addressed.

Over its first five cohorts, the program expanded to include cardiovascular and cardiometabolic disease research. Hundreds of early-career physician-scientists have completed or are completing the two-year curriculum, which pairs rigorous trial design training with community engagement methods. Each scholar receives a $240,000 award intended to protect 40% of their time, freeing them from the clinical and administrative duties that often crowd out research in the early career years.

Now, for the first time, the program is opening its doors to a third discipline: neuropsychiatry.

Why neuropsychiatry, and why now

The timing reflects a convergence of factors. Neuropsychiatric drug development is accelerating, with new anti-amyloid therapies for Alzheimer's reaching the market and novel approaches to schizophrenia and ALS entering clinical testing. But the pipeline's diversity problem is acute. A 2023 analysis of Alzheimer's clinical trials found that Black participants made up roughly 4-5% of enrollees despite representing an estimated 19% of Americans with the disease. Latino enrollment showed similar gaps.

The consequences are real. Lecanemab and donanemab, the recently approved anti-amyloid antibodies, were tested in populations that were overwhelmingly white and well-educated. Whether the efficacy and safety profiles hold across diverse populations remains an open question, one that could have been addressed earlier with more inclusive trial design.

"Clinical researchers in neuropsychiatry are making outstanding progress in understanding complex disorders, however, as in many other areas, the challenges of representative clinical trial enrollment persist," said Megan Becker, Executive Director of the Winn CDA program.

What the award covers, and what it asks in return

The mechanics of the Winn CDA are straightforward. Selected scholars enter a two-year program that combines didactic training in clinical trial methodology with mentorship from experienced trialists. The $240,000 award is not a traditional research grant; it's salary support designed to buy protected time. The philosophy is simple: early-career physician-scientists can't build community partnerships and design inclusive trials if they're running a full clinical schedule.

In exchange, scholars are expected to design and ideally launch trials that demonstrate both scientific rigor and meaningful community engagement. The program emphasizes that these two goals aren't in tension. Broader enrollment doesn't mean looser inclusion criteria; it means smarter recruitment, deeper community trust, and trial sites that actually reach underserved populations.

The Winn Awards program has attracted growing financial support. Beyond the founding Bristol Myers Squibb Foundation, Gilead Sciences, Amgen, and Genentech have all joined as funding partners. Ali Gemma, Program Director of the Winn CDA, said the team is particularly interested in applicants focused on Alzheimer's disease, Parkinson's disease, ALS, MS, and schizophrenia.

The gap between intention and enrollment

Programs like the Winn CDA sit within a broader reckoning in clinical research. The FDA has increasingly pushed for diversity action plans in trial applications, and the 2024 DEPICT Act now requires sponsors to submit demographic targets. But mandates don't automatically translate to enrollment. The bottleneck is often at the investigator level: researchers who don't have the training, time, or institutional support to build trust with underrepresented communities simply can't recruit from them.

This is where the Winn model differs from a typical grant mechanism. It doesn't just fund research; it builds a network. Alumni from previous cohorts form a growing community of trialists who share strategies, recruitment approaches, and lessons learned. The bet is that changing the culture of clinical trials requires changing the people who run them.

Still, the program has limitations worth noting. Two years and $240,000, while substantial, represent a fraction of what's needed to launch and complete a clinical trial. The award is a career accelerator, not a trial funder. Whether scholars go on to secure the larger grants needed to implement what they've learned depends on many factors the program can't control: institutional support, funding landscapes, and the willingness of sponsors to invest in diverse trial sites that may not be traditional academic medical centers.

Applying for Cohort 6

The program is currently accepting applications for its sixth cohort, with a deadline of May 4, 2026. Eligible applicants are early-stage investigator-physicians working in neuropsychiatry. The Winn CDA team has indicated they are available to provide guidance to prospective applicants, and questions can be directed to winncda@vcu.edu.

Whether this expansion moves the needle on neuropsychiatry's diversity problem will take years to assess. The first neuropsychiatry scholars won't complete the program until 2028 at the earliest, and the trials they design will take longer still to produce results. But the alternative, continuing to test neuropsychiatric drugs in populations that don't reflect the people who will use them, is a status quo that the field can't afford to maintain.