The White House’s Office of Science and Technology Policy (OSTP) recently solicited stakeholder feedback on the clinical research infrastructure for emergency clinical trials, for which PhRMA submitted comments. PhRMA shares OSTP’s recognition of the importance of having a clinical trial infrastructure that supports sites that are ready to respond to emergency situations like COVID-19. We also agree that one goal of such an infrastructure should be to support the expansion of clinical research into underserved communities by increasing diversity among both trial participants and clinical trial investigators.
The COVID-19 pandemic raised the public’s consciousness about gaps in the clinical trial infrastructure and about barriers that many underrepresented communities may face when it comes to participating in a clinical trial. As we look at the development of new medicines during both emergency and non-emergency situations, it is essential to take meaningful action to help ensure that underserved and underrepresented communities, who have historically faced barriers to participating in the development of health care advances, are given the opportunity to be included.
The full comments underscore several of the learnings surfaced during PhRMA’s ongoing exploration of a community-based infrastructure supporting clinical trial diversity, which began in June 2020. Through that exploration, PhRMA has engaged with community stakeholders, patients, trial sponsors and clinical trial experts to identify current barriers to inform potential solutions that may support a sustainable infrastructure focused on enhancing clinical trial diversity in underserved communities. Many of these learnings apply to an infrastructure supporting emergency clinical trials, as well as non-emergency clinical trials.
Our comments explore three specific ways to increase diversity in clinical trials: 1) expanding clinical research sites in underserved areas, 2) using decentralized clinical trials and digital health technology innovations, and 3) having a network of sites in a state of readiness to undertake additional or future clinical research.
Trust, outreach and education are key for expanding clinical research sites in underserved areas. While robust measures are in place to protect patients’ rights, including privacy of patient data, some patients, particularly from communities of color, may have lower levels of trust in the medical research community. Recognizing and addressing patient concerns is critical to building the trust needed to enhance clinical trial diversity.
Outreach to and education of not just potential trial participants but also health care providers is also key. The clinical trial process is complex and multifaceted, and there is often a lack of clinical trial awareness at hospitals and clinics that treat diverse populations. Outreach to medical professionals in underserved communities, including comprehensive education at local sites with local providers on medicine development, can help address this gap.
The use of decentralized trials and digital health technologies can also play a role in better supporting emergency clinical trials and enhanced participant diversity. Traditionally, patients participating in a clinical trial must travel to a physical hospital or clinic, which can be burdensome because of travel and financial implications, schedules, caregiving responsibilities, and a host of other factors. As evidenced during the COVID-19 pandemic, the use of decentralized clinical trials may help reach people who may not be able to easily access a trial site and support trial participation by reducing or eliminating in-person site visit requirements. Additionally, the use of digital health technologies, such as mobile devices, may allow remote data collection.
There is a potential for digital health technologies (DHTs) to provide scientific and practical advantages in supporting the assessment of patients by generating information outside of the traditional clinic visit though it must be recognized that there is significant variability in access to broadband and digital technologies. DHT tools, which encompass a range of solutions that include digital apps, in-home testing, remote monitoring and diagnostics, and other technologies, may help improve diverse participation in clinical trials when coupled with other efforts and resourced appropriately.
Finally, creating an infrastructure that includes a network of clinical trials sites connected and supported by robust communication, community relations, ongoing site training and mentoring, sustainable support and standardized platforms and metrics serves not just emergency clinical research, but overall equitable access to clinical trials. Having a network of sites in a state of readiness to undertake additional or future clinical research, i.e., a “warm base,” can help facilitate clinical trials more efficiently during an emergency.
Read PhRMA’s full comments to OSTP and learn more about our efforts to enhance clinical trial diversity.