Driving diversity in clinical trials

Participation in clinical trials has historically suffered from a lack of diversity, despite chronic diseases disproportionately affecting people who are non-white. Jennifer Jones-McMeans, Divisional Vice President of Global Clinical Affairs at Abbott’s vascular business, tells us how Abbott is leading the way to ensure its clinical trials are inclusive and diverse.

Pharma IQ: Why is there a lack of diversity in clinical trials?

Jennifer Jones-McMean: When you look at what inhibits patients from participating in clinical trials, one reason is a lack of access to physicians or nurses that may look like them. It relates to lack of trust, because if I don't trust my physician or if I think the nurse does not believe me, that is an inhibitor. We know that there is a historical context in many diverse communities and among women, where there has been a lack of care or a lack of ethical behaviour, and that has continued from generation to generation.

Pharma IQ: Is there greater awareness of health inequities as a result of the Covid-19 pandemic?

JJM: When it comes to race and gender the issues around health equity have always been around. The pandemic, as painful as it has been, did provide this opportunity where there was an uncovering to a higher extent of the challenges that patients face. It became very clear that this disparity did not just exist with the Covid virus but exists with many other diseases too.

Pharma IQ: What is Abbott doing to recruit people from different backgrounds to its clinical trials?

JJM: We have made it part of our corporate campaign that we ensure patients are well represented by gender, race and ethnicity. One area we saw that needed further improvement was ensuring that the investigators, physicians, nurses and research coordinators represent the population that is in need. If women or patients of color are not seeing physicians and nurses that are from their community, that they share a common language and cultural understanding with then it becomes very difficult to have a conversation about whether they would be willing to participate in a clinical trial for a therapy that could potentially help them and many other patients like them.

There is lots of different information available on understanding diseases and it can be very nerve-wracking when someone comes [to the hospital] for a visit, especially during Covid-19. We thought it would be very helpful to create a website for patients and families that provided a single source of reliable information to educate the patient on their disease, on potential therapies and on what a clinical trial really is and how it could help. We have printed materials as well, because while I think the website is wonderful we know that there are certain populations for who print is very helpful.

We received feedback from one of our trials telling us that patients who did not speak English were not being approached. Since then we have ensured that every clinical site has translation services available, so patients can hear about the trial and make their own choice, rather than someone else make the choice of whether they will be part of the trial or not.

Pharma IQ: Are more people enrolling onto clinical trials as a result of these efforts?

JJM:We have the data to show that enrolment at one particular trial where we implemented all these resources did increase. I think that will continue and over time we will need to see how this impacts the overall enrolment. The way I look at clinical trials is that they have their own fingerprints, so how I structure these types of resources for one trial is going to be very different for other trials. We design these resources based on the needs of the population.

Pharma IQ: How do you see this progressing in the future?

JJM: Abbott is making an investment into ensuring our clinical trials are as equitable as possible. We have invested in historically Black colleges, universities and medical schools, the National Black Nurses Association and the National Association of Hispanic nurses to train a new generation of investigators, physicians and nurses. We have also invested internally to make sure there are financial resources across our business units so that when trials are being conducted, there is a way to access and implement many of the tools I mentioned that trials need.

We are working with healthcare providers and stakeholders to get more feedback on what is needed by the patients, because while we can have this discussion internally, we need to know what our stakeholders are asking us to do. We have also developed the Medical Advisory Board, where we have physicians who are very well versed in diversity, inclusion and the treatment needs of patients. They are working with us to give us their feedback on what to do next. We need to put patients at the center so they are seen and cared for, while we also reduce these barriers to enrolment.

Quick links

• How to improve the success rate of clinical trials
• Webinar: The technology enabling decentralized clinical trials
• The five most popular countries for clinical trials – and why they appeal to clinical sponsors
   

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