The ABCs (and Ds) of Clinical Trial Diversity

When the FDA mandated guidelines earlier this year for broader clinical trial diversity and inclusion, it brought a long-standing challenge in pharma and life sciences into the spotlight. Here, Alexandra Moens, H1’s Director of Product Marketing, joins a Q&A on where to start, why accountability matters, and how to break with traditional modes of research to encompass a more diverse and inclusive patient and investigator population.

Q: The Medical Affairs Professional Society (MAPS) recently started a diversity training specifically for the Medical Affairs role. Why is it critical that it starts here and spans the spectrum of the drug life cycle? What are some specific challenges (perhaps regarding workflow/pain points) within the med affairs/research space do you believe may compound this issue?

A: I think of this in terms of three points that contribute to this being an ongoing challenge for Medical Affairs teams.

Accountability (Lack of):

For a long time, there hasn’t been a lot of accountability for pharma companies. We’re now starting to see some changes in that with the FDA guidance encouraging companies to submit a diversity plan and Medicare showing first signals of drugs not being covered for patient populations who were not properly included in the clinical testing stages.

Lack of data insights:

In most cases, the data you need to make informed decisions is available out there, but what is often missing is bringing it back together in a meaningful way and building a strong diversity strategy based on intelligence. Having a strong data partner to surface relevant and impactful insights can be a great help.

Lack of an action plan:

In order to make meaningful decisions and progress, you need to have an action plan that you’re willing to question and reiterate to find the best possible outcome for patients. You need to understand what you want to achieve as an organization and as a team, develop a progression action plan on how you plan to reach that goal as well as adopt diversity efforts at every level of the company.

Q: We know that disparate groups are underrepresented in clinical trials and diversity is severely lacking. Where do we even begin to address the challenge outside of government guidelines and mandates?

A: No matter the role within a pharma company, clinical trial diversity should be a strategic priority at every stage of drug development and launch — from Medical Affairs to Clinical Operations to Marketing. I think of diversity in terms of ABC and D.

A – Awareness

Or sometimes more importantly, the lack of it when it comes to clinical trials. According to polls published in a Deloitte article, 85% of the population might be interested in participating in a clinical trial but don’t because of bias, lack of information or generally never having been asked to participate. We need to understand what it takes to move the needle and help make ethnic and racial minority communities aware of what trials are available to them and how they can benefit long-term both from medicines developed and access to care they provide. Pharma companies often don’t connect the outcomes of the trial with potential improvement in overall health for the patients that the drugs will benefit.

B – Burden

…and the high toll participating in clinical trials can have. In the majority of cases, participating in a clinical trial is not conducive to the patient’s way of life, location or ability to access the trial (social determinants of health). If you combine that with lower income households and/or a lack of health insurance, the cost of trial participation is often just too high. Sure, the treatment itself during the trial is free and some compensation is usually provided, but that does not cover the burden of participation. Patients in households making less than $50,000 per year were 27 percent less likely to participate in trials. The African American median household income in 2017 was about $40,000, compared with $68,000 for non-Hispanic white Americans.

C – Confidence

…in the system, and again often the lack thereof (trials, drugs and companies). Specifically, there has been a general distrust in medical research and clinical trials. We need to help rebrand the image that patients are experimental subjects when participating in clinical trials, and deepen the understanding that they can be a critical part of our healthcare system’s future and contribute to bigger efforts like health equity.

The healthcare providers that serve those communities are typically best positioned to build trust and establish relationships or communicate about available trials. Some patients prefer being treated by doctors of their own race or gender as they feel better understood. Therefore, it is important to understand not only the patient’s race but also the provider’s race. Knowing that in 2018, among active physicians, 56.2% identified as White, 17.1% identified as Asian, 5.8% identified as Hispanic, 5.0% identified as Black or African American, and 13.7% identified as unknown, it is not surprising that a large part of the potential patient population is underrepresented in clinical research too.

D – Disqualification

Patients of non-white races and with diverse ethnic backgrounds are more likely to have other health issues, such as high blood pressure, diabetes or heart disease. Due to increasingly stringent trial inclusion criteria, having multiple conditions often precludes those patients from participating.

We all need to do better. We need to communicate with patients to better understand why they don’t participate in clinical studies and why they distrust the organizations conducting trials. Pharma needs to build trust and relationships with diverse key opinion leaders (KOLs), patient advocacy groups, physician groups and patients.

This is a key takeaway for both the physicians treating the patients (how can I better understand and engage with my patients and community) as well as for the companies and researchers setting up new studies (how can we communicate the benefits and mitigate patient hesitation and risks of them dropping out). We are all in this for a more equitable healthcare system, but it has started with a fundamental understanding of the current status: making strategic and operational changes and taking an honest look at the communities we strive to make healthier.