Why Improving Inclusion and Diversity in Clinical Trials Should Be a Research Priority | Deloitte US has been saved
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By Karen Taylor, research director, UK Centre for Health Solutions, Deloitte Services LP
Several weeks ago, I participated in a panel discussion on inclusion and diversity in clinical trials. My research for the event and the discussion that ensued led me to conclude that while there have been some improvements, the pharma industry continues to struggle to recruit enough trial participants from important demographic groups, especially women, racial and ethnic minorities, and the elderly. As a result, the outcomes seen in clinical trials are likely to be unrepresentative of the patient outcomes in the real world.
The mismatch between population demographics and participants in clinical trials
The basic assumption of clinical research is that investigators take data from a relatively small but representative selection of subjects and generalize the results to the larger patient population. If the sample is too constrained or poorly selected, it hinders the broad applicability of the results. This is a statistical concern—and an ethical and medical one. Challenges include reluctance to conduct trials in “vulnerable populations,” namely children, cognitively impaired individuals, pregnant women, and the elderly, as concerns over the risk of doing more harm than good leads to “playing it safe” and excluding vulnerable populations from trials.1
There is general acknowledgement that there has historically been a mismatch between the demographics of a population that a new therapy is expected to treat and the participants in the related clinical trials. Despite numerous initiatives to try and tackle this problem, increasing clinical trial diversity in an effective, sustainable, and scalable manner remains a challenge for the pharma industry, academic institutions, and clinical research in general.2
Today, fewer than five percent of adult cancer patients participate in clinical trials, with ethnic and racial minorities enrolling at even lower rates. Economic concerns play a role, as low-income patients might lack adequate resources to pay for travel, childcare and/or time away from work. Research also shows that symptoms of conditions such as heart disease, cancer, and diabetes vary by ethnicity as they do between the sexes. Consequently, if diverse groups aren’t part of research studies, it’s difficult to be sure of treatment equity—or potential side effects.7
Recent initiatives to improve diversity in clinical trials
In recent years, many organisations, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have launched initiatives to improve the diversity of clinical trials enrollment. For example:
There is a wide body of research identifying the barriers impacting minority patients’ willingness to participate in trials. In November 2018, a comprehensive report identified key themes, solutions, and a communications message map to support a multi-stakeholder approach for overcoming five critical barriers to greater diversity in participation: mistrust, lack of comfort with the clinical trial process, lack of information about clinical trials, time and resource constraints associated with participation, and lack of awareness about the existence and importance of clinical trials.9 It also identified potential solutions to improve recruitment of racially and ethnically diverse patients to help industry and academic investigators to develop strategies for increasing diversity in clinical trials.
Financial incentives can promote participation, especially when linked to participant costs and effort. Use of financial incentives, without undue coercion of any population, can help equalize study participation.10
Research also suggests that providing transportation, flexible hours for patients, appropriate compensation, and mobile technology support such as apps for patients (and mobile phones for those who do not have one), together with increased transparency in reporting, could help increase diversity in clinical trials.
Importantly, the pace of digital transformation in pharma can also help address the above issues, especially the increasing use of mobile technology and social media platforms to improve communication between researchers and support of trial participants. Telemedicine is also a game changer when it comes to extending patient reach by giving patients access to mobile and video encounters with health care providers. Virtual clinical trials mean that any qualifying patient who wants to participate in clinical research might not be limited by location.11
These technology solutions, together with actionable evidence on ways to improve recruitment, can provide opportunities to increase the diversity of trial participants and improve their satisfaction—and overall experience.