Finding the Trust in Clinical Trials: Q&A with Lisa Bailey

Lisa Bailey
Managing director and
head of DE&I strategy
Trinity Life Sciences

As more and more companies are embracing DE&I, it’s becoming clear that the life sciences industry needs to do better in regard to diversity when populating clinical trials. Lisa Bailey, managing director and head of DE&I strategy at Trinity Life Sciences, spoke with Pharmaceutical Executive about her research into the issue and how the industry is working to solve the problem.

Pharmaceutical Executive: Can you discuss your recent research into DE&I and clinical trials?
Lisa Bailey: This is the second in a series of papers that we’re doing on clinical trials and DE&I. The first paper looked at what was being done to recruit diverse populations, while the second paper takes the learnings from the first and provides a better understanding of what initiatives are being taken at a corporate level to improve the diversity of trials. The goal is to get a better understanding of the effectiveness of these initiatives and FDA’s guidance to improve diversity now and in the future.

PE: How significant a role does mistrust play in preventing diverse populations from participating in clinical trials?
Bailey: As part of the study, we highlight some barriers that we uncovered, and one of those barriers is mistrust in healthcare. Five of the 15 executives we interviewed as part of the qualitative portion of the paper identified this as a major barrier. It definitely comes up. There’s a historical piece that comes around as part of this, especially for African Americans (such as the Tuskegee Experiments).

However, the other piece that we’re hearing a bit more is that there has been information getting out to the public around the lack of diversity in clinical trials. If you think about the current population, about 40% of the population is made up of ethnic and racial minorities. Only about five to 10% of the clinical trial participants are from minority populations.

That’s getting out to the broader population. Just anecdotally, from having conversations with patients and doctors, they’re hearing more and more that patients from underrepresented groups recognize that the people in these trials may not look like them. They wonder if they can trust the science related to the trials.

PE: How will FDA’s recent guidance on clinical trials impact this?
Bailey: On June 26, FDA made the guidance available, which aligns closely with when our paper came out. One of the things that they highlighted is the idea of a diversity action plan. That’s going to be required for new drugs in phase III studies, but FDA is also encouraging the implementation of DE&I related strategies earlier if possible.

One of the key things that stood out to me is that FDA is being very specific in its requirements, such as wanting to know the total number of subjects initially planned for inclusion, and the numbers entered into the study tabulated by race, gender, and age. It also wants to know information related to safety and efficacy for these groups and whatever information is available for modifications for dosing or sub-dosing for subgroups. That is very specific guidance around this piece. If pharma companies are able to do these things, they can potentially assuage concerns from the population over whether it will be representative of the general population’s experience with the product.

PE: What steps are being taken at a corporate level?
Bailey: We looked at publicly available materials over what sort of information is being put out around DE&I in clinical trials. One thing that was promising is that there is a trend since 2018 that shows an increase in representation in corporate documents. There is a significant jump in 2022 and 2023 for DE&I.

Where a concern comes in is that there wasn’t necessarily a consistent or transparent way in which some of this information was being communicated. One bright spot was obviously GSK, who have done a lot in terms of putting themselves at the forefront of this issue. We highlighted that 100% of the company’s phase III trials included a diversity plan at the end of 2022. They’re already aligned with FDA’s guidance.

PE: Will the rise of decentralized clinical trials positively impact this issue?
Bailey: There are definitely some things that will be helpful in having a decentralized approach. One of the things that we call out as a tactic to improve is the idea of telehealth visits and making things more accessible. There are a lot of burdens that go into place for being a participant in a clinical trial, so if there are ways to overcome that, that is helpful.