Improving representation in clinical research is a goal many sites and sponsors share. Still, many questions remain as to how best to achieve that aim.
Recently representatives from Deloitte and the Pharmaceutical Research and Manufacturers of America (PhRMA) released an insightful report touching upon inclusivity and diversity in clinical trials. The document outlines current issues impacting the industry, why working toward improvement is vital, potential solutions, and the power of collaboration in improving representation in certain communities.
Outsourcing-Pharma spoke to two leaders about the report, and what it might mean for the future direction of the clinical trial industry:
- Debra DeShong, executive vice president of public affairs at PhRMA.
- Sonal Shah, life sciences research leader of the Deloitte Center for Health Solution
OSP: Could you share some of the ways in which sites and sponsors struggle with inclusivity/diversity in trials?
SS: Through our research, we found that there are three primary barriers to enhancing diverse clinical trial participation: mistrust, lack of awareness, and lack of access. For example, a longstanding history of mistreatment of Black and other minority populations by researchers, like the Tuskegee Syphilis experiment, or the use of Henrietta Lacks’s cells without her consent, continues to engender mistrust.
We also found that many patients, regardless of race and ethnicity, are not made aware of opportunities to participate in clinical trials or the benefits they might provide. This could be due to a lack of awareness by a patient’s treating physician, or biases that might prevent a clinical trial investigator from asking underrepresented patients to participate in clinical trials.
A lack of access is also a factor and is driven by the existing clinical trial infrastructure. A survey of PhRMA member companies reveals that 77% of respondents acknowledge that there is a lack of existing clinical trial sites in zip codes where underrepresented patients live. In addition to traveling long hours to get to clinical trial sites, patients often face other inconveniences such as time away from work, lack of caregiver coverage, and financial expenses.
DDS: A key piece of health equity is earning the trust and addressing the systemic issues that deter underrepresented communities from participating in clinical trials. From the research we conducted, we found that some of the barriers to recruiting diverse volunteers include a lack of awareness about clinical trials, a lack of convenient access to clinical trial sites, and mistrust by underrepresented communities and populations.
OSP: Please tell us some of the reasons why PhRMA and the Deloitte CHS decided to take on the issue in this way, and how you designed the effort.
DDS: One of the three pillars of PhRMA’s Patient-Centered Agenda is a commitment to building a more just and equitable health care system. As a part of that commitment, this report is one example of a long-term effort to identify barriers and solutions to enhancing diversity in clinical trials so that the trials supporting the approval of medicines are more representative of the patient population aimed to be treated.
We wanted to pull together all the different communities and experts who have a role to play in delivering greater diversity in clinical trials. This work builds on a survey of PhRMA members, community survey, and focus groups, and an extensive stakeholder workshop we held back in June, among other parts.
SS: The COVID-19 pandemic and racial unrest in 2020 that grew following the tragic deaths of George Floyd, Breonna Taylor, and so many others illuminated long-existing health and social inequities in the US. These inequities are particularly stark in health care and health outcomes, as demonstrated by the disproportionate impact of COVID-19 in Black and Latinx communities across the US.
Enhancing diverse participation in clinical trials is one way to help foster better health outcomes and improve care for racially and ethnically diverse communities. Racial and ethnic diversity among clinical trial participants is important to support science-driven strategies aimed at understanding the needs of those who are affected by the disease or condition being investigated, to improve public confidence in drugs once marketed, and to advance health equity by providing access to potentially life-saving therapies and quality health care that might not otherwise be available.
We knew that industry efforts were underway to enhance diversity in trials, but there was little information being shared about the status of those efforts, their impact, and opportunities for the future. We set out to work together to develop this body of knowledge and disseminate it widely in hopes of advancing dialogue and action on this very important and timely issue.
The methodology was designed in order to capture 360 perspectives from all of those involved in clinical trials: biopharma companies, academia, government, patient advocacy, community leaders, patients, health care providers, technology experts, and clinical research organizations. Targeting some of these groups individually such as biopharma companies (through surveys and interviews) and patients (through focus groups) helped us to draw out similarities and differences in how each group perceives the problem and where they each see opportunities for improvement.
OSP: In addition to this report, can you tell us about any other efforts/accomplishments the Equity Initiative has announced since its launch in June 2020?
DDS: Over the past year, we have committed ourselves to this work through our Equity Initiative. In addition to several policy papers letters and comment letters that we have written and submitted over the past year, we also just hosted a virtual Graduate Summit in October to connect diverse talent to our member companies. Over 600 participants joined panel discussions and networking forums where PhRMA distributed over 350 resumes from talent to our member companies.
Further, in April of 2021, PhRMA members adopted the first-ever, industry-wide principles on clinical trial diversity. The principles focus on four main areas: building trust and acknowledging the historic mistrust of clinical trials within Black and Brown communities, reducing barriers to clinical trial access, using real-world data to enhance information on diverse populations beyond product approval, and enhancing information about diversity and inclusion in clinical trial participation.
Finally, and as an important element of this report, PhRMA hosted its first stakeholder workshop in June with over 500 health care community members from over 150 organizations to focus on improving diversity in clinical trials.
OSP: Could you please share what you think the key takeaways from this are?
SS: The research highlights that PhRMA member companies and industry stakeholders are in alignment on what the barriers are to enhancing diversity and they are working to address these barriers, but they are at different places in their journey.
What we would like to emphasize is that there are four key areas for companies and clinical trial stakeholders to focus on to close gaps in recruiting and retaining diverse populations:
- Identifying and developing sites focused on treating underrepresented populations: While companies have tried many different tactics, this is the one most reported to have an impact on increasing enrollment and retention of diverse populations. It’s important to meet patients where they are and work with health care providers they already trust.
- Developing and training diverse investigators and site staff: Patients tend to trust providers who look like them, so companies and researchers should work on attracting physicians from underrepresented populations to clinical research and creating opportunities for them to serve as clinical trial investigators
- Building community relationships: Companies and researcher sponsors should work with the community to build longstanding bi-directional relationships that expand beyond the transactional nature of any one clinical trial, and focus those relationships on elevating health equity in the community overall
- Establishing measures and metrics for success: It’s important for clinical trial stakeholders to understand whether or not investments being made to increase diversity actually do. And if not, data would enable pivoting those efforts and investments to strategies that might be more productive.n
It was also clear from our research that no one stakeholder can do this alone. Changing the current clinical trial paradigm and infrastructure will require partnership across all those involved including companies, academics, health care providers, community leaders, and patients.
DDS: Our findings serve as a reminder that there is true momentum behind enhancing clinical trial diversity, with actionable strategies – like developing diverse investigators and creating a community-based network of clinical trial sites in underserved communities – to accomplish it.
OSP: Anything to add?