By Margaret Anderson, managing director, Deloitte Consulting LLP
Clinical trials take data from a small, but representative selection of subjects and generalise the findings to the wider population. However, as we have discussed in our previous blogs on the subject, Why improving inclusion and diversity in clinical trials should be a research priority and Diversity and inclusion in clinical trials – an imperative, especially in times of COVID-19, overcoming the lack of diversity in clinical trials is a medical and ethical imperative to achieve true representation of the patient population. This week’s blog, by Margaret Anderson, our Strategy & Analytics Diversity, Equity and Inclusion Leader in Deloitte Consulting, appeared first as a US Center for Health Solutions, Health Forward Blog and reflects on the stakeholder interviews our US colleagues conducted to understand how diversity could be improved in clinical trials.
Pharmaceutical companies shouldn’t work to improve diversity in clinical trials just because it’s the right thing to do. They should do it because having a deeper pool of participants builds evidence that therapies in development might benefit a more diverse population of patients. Moreover, clinical-trial diversity can help to build public confidence in therapies once they become available. However, a general distrust of the health care system, logistical barriers, and an overall limited understanding of clinical-trial processes and opportunities can keep racially and ethnically diverse populations from participating. As a result, new therapies are often tested on patients who might not reflect the intended treatment populations.
Last spring, the Deloitte Center for Health Solutions interviewed 26 stakeholders from 22 organisations to understand how diversity could be improved in clinical trials. We wanted to learn more about the barriers that keep some patients from enrolling in trials and hear about strategies that could remove some of those obstacles. Details from these interviews will be published in the fall.
In April, the Pharmaceutical Research and Manufacturers of America’s (PhRMA) launched its voluntary, industry-wide principles on clinical-trial diversity—part of a broad initiative to improve health equity for ethnic and minority populations. The trade group recently hosted a two-day virtual workshop, Partnering for Health Equity: Advancing Research through Representative Clinical Trials. More than 500 stakeholders (from 150 organisations) participated. Workshop attendees, including myself, discussed the root causes of health inequity, the patient and community perspective of clinical trials, and innovative efforts focused on diversity across the clinical-trial ecosystem.
During my presentation, I shared some of the strategies that emerged from our recent stakeholder interviews. Here’s a look:
- Get the community involved:All of our interviewees agreed that community engagement is critical for convincing people to participate in clinical trials. Organisations that sponsor clinical trials should be willing to have bi-directional conversations with community leaders to determine how working together can benefit the pharmaceutical company and the community. Creating a connection to a community can help establish a level of trust and foster sustainable relationships. Offering free health education or health screenings to members of the community, for example, could be a good place to start.
- Meet patients where they live:Bringing trials to diverse communities could result in a patient population that is more representative of intended treatment populations, as my colleague Amy Cheung noted in her recent blog on drug-development strategies. Pharmaceutical companies should look beyond traditional locations for clinical-trials. Federally qualified health centers (FQHCs), Catholic health systems, historically black colleges and universities (HBCU) medical schools, local pharmacies, and other non-traditional locations could attract a more diverse group of patients. Leaders of these organisations could serve as trusted messengers in the community. But it’s important to note that FQHCs and similar organisations might have limited funds or few resources to dedicate to trials. Stakeholders suggested that offering financial support to those organisations could help build trust within communities and among patients. Some interviewees also suggested that community workers should be compensated. Unpaid work could erode trust, they said.
- Increase diversity among current and next-generation investigators:Several stakeholders noted that there is often a lack of diversity and/or cultural competence among investigators and on-site personnel. They suggested that stakeholders try to recruit, train, and mentor qualified site staff from diverse backgrounds. Partnering with HBCUs, for example, could expose students to clinical research as a career. Some interviewees said it isn’t enough for investigators and site personnel to “look like” the patients they serve. They also need to understand the culture and preferences of patients who are eligible to participate in clinical trials. Stakeholders also told us that limited time and resources can prevent clinicians from participating in research. They stressed the importance of incentivising or facilitating under-represented minorities to get involved in clinical research. Stakeholders also told us that exposure to research during early career development can help foster interest in the field. One academic stakeholder partnered with HBCUs to recruit students as interns and expose them to clinical research in hopes they might pursue it as a career.
- Invest in technology and data to find and track patients:Stakeholders pointed to the lack of real-world data and dashboards for understanding the racial and ethnic mix of patients who are screening and enrolling into clinical trials. This kind of data, combined with real-time information about screen failures and drop-outs, could help clinical-trial sponsors target more diverse patient populations and course correct recruitment strategies as needed. Further, this data could also help hold investigators accountable for clinical-trial diversity.
Consider this: More than 5,000 cancer patients participated in clinical trials that led to the approval of 17 new therapies, according to the Food and Drug Administration’s 2018 Drug Trials Snapshots. However, just seven per cent of trial participants were Black, and 13 percent were Latinix. Enhancing meaningful representation of diverse participants in clinical trials helps provide information about drug response and measures of safety and efficacy in populations that have historically been under-represented and under-studied.
During our interviews, most stakeholders agreed that there is no single solution that will enhance clinical trial diversity. It requires a combination of several different approaches that should be tailored to the target population. Enhancing 'clinical-trial diversity' can enable health equity by ensuring fair and just opportunities for participation in clinical trials. However, the focus should remain on the overall priority to enhance the wellbeing for the population, which takes time.