FPM Conversation Blog – Enabling a Greater Diversity of People in Clinical Trials

The onset of the COVID-19 pandemic has highlighted some of the potentially disproportionate effects that different ethnic groups may face – from addressing recent gaps in vaccination between different ethnic groups, to the lack of diversity in some clinical trials: it is thus important to focus on the individuals studied, towards optimizing the product’s end-label.

When it comes to increasing diversity in clinical trials, we can focus on:

• Practical tools for implementation
  • Recent projects focusing on the implementation of practical tools include the Multi-Regional Clinical Trials (MRCT) Center in the United States and the National Institute for Health Research (NIHR) in the United Kingdom. The MRCT Center has a diversity in clinical trials project through which they also provide a guide and tool kit to achieve diversity and equity in research. The NIHR has a broad framework that aims to increase diversity in clinical trial, with a specific stream focusing on ethnicity.
• Regulatory guidelines
  • The Food and Drug Administration in the U.S. has published a set of broad guidelines to increase diversity in clinical trials for demographic and non-demographic characteristics. Through such, they aim to broaden the eligibility criteria to increase diverse enrolment, establish inclusive trial practices, decrease the burden of study participation, and to foster community engagement.
• Leadership
  • Recent leadership initiatives have been introduced by the Pharmaceutical Research and Manufacturers of America (PhRMA), the Centre for Black and Minority Ethnic Health (CBMEH) based in Leicester, and the Equality, Diversity, and Inclusion in Science and Health Group. PhRMA has produced a new chapter for conduct in clinical trials. A key point from this chapter is the importance of building trust and recognizing past wrongs, especially for Black and Brown communities. CBMEH aims to reduce health inequalities by increasing cultural competency in research and in the community. They have a series of videos in collaboration with National Institutes of Health (NIH) for the delivery of inclusive research. One of these focuses on increasing ethnic diversity in research by conducting research not just to or about a specific group but rather by and with members of said population. They also recommend promoting engagement from the beginning of research through collaboration, and by the acknowledging of historical past and current experiences of racism and discrimination. The EDIS Group encompasses a coalition of health organisations that are currently working on inclusive events to support career progression and the expansion of diversity in research design.

To promote and increase diversity in clinical trials we should also focus further on:

• Paying attention to which medications we develop
• Evaluating how we make decisions on which medications companies decide to invest in
• Gathering diverse input when deciding which medications we develop
• Ensuring the research design teams themselves are diverse
• Disclosing results to the public that the research is catered to
• Tailoring projects to the groups of people we wish would participate further, for example by working with community leaders to increase outreach and promote collaboration

• Even major published clinical research articles in reputable journals can exhibit some “tokenism” in the breakdown of participants’ demographics. This has potential for repercussions because there can be more limited diversity of the included participants, the research conducted may not match the healthcare burden of the target group, and differences in response across different groups to a given healthcare intervention may fail to be accounted for. To promote the inclusion of under-served groups, patient recruitment and more study engagement in Rare Disease research, we must also account for: language barriers, cultural barriers, structural racism, social determinants of health, socioeconomic areas, and burden of co-morbidity.
• In addition to accounting for these factors, more attention can also be directed to improvements in the strategic recruitment planning for participants. If the recruitment of study participants is not conducted correctly the research study is more likely to be terminated or be unsuccessful.  With the aim to further increase diversity in clinical trials, the NIH requires that ethnic minorities make up at least 30% of the participants in research studies. When designing a clinical trial, all stakeholders must be identified and engaged, source of treatment and information for participants must be identified, and the way in which information will be disseminated must be clearly outlined and understood.
• It is also important to ensure that the research conducted is context specific, collaborative (e.g. no major decisions made without consulting the Rare Diseases Group(s) under study), considers equity of access (both to clinical trial and later to medication), includes a diverse group of participants, and addresses additional barriers surrounding Rare Diseases research. Unfortunately, sometimes there may be: too little investment for diseases affecting a small percentage of the British population; potentially less interest in the disease under study; limited research opportunities due to a lack of patients’ access to designated research centres; financial influences from the potential for participation in the study due to monetary incentives; the influence of participants’ perception on treatment administered.
• The INCLUDE Project is an initiative that is making strides in the tackling of barriers in recruitment of participants, which includes a tailored framework for ethnicity.