Increasing participation of communities of color in COVID-19 vaccine clinical trials.
By: Dr. Anthony Salandy
Date: 24th November 2020
The diversity of participants in COVID-19 vaccine clinical trials would help provide valuable information on the safety, efficacy, and vaccine response in historically under-represented and under-studied populations. Data indicate people of color shoulder a disproportionate disease burden for COVID-19. For instance, Blacks are more than two times as likely to be hospitalized with COVID-19 than their White counterparts.
Safe and effective COVID-19 vaccines are seen as the last line of defense for an ever-expanding pandemic. With this in mind, some have argued, clinical development of a COVID-19 vaccine should be representative of those most affected by the disease.
Thus, pharmaceutical companies, clinical research organizations (CROs), and medical institutions (e.g., Vaccine and Treatment Evaluation Units – VTEUs) have committed to work with patients, patient advocacy groups (e.g., The Institute for COVID-19 Vaccination Advocacy), regulatory authorities, healthcare practitioners, academics, and policymakers to define the systematic and impactful approaches to enhance the diversity of clinical trial participants and help reduce healthcare disparities.
COVID-19 clinical trial studies should encourage the inclusion of individuals from a diverse range of backgrounds including, but not limited to race, ethnicity, sex/gender, and age in clinical trials through broad eligibility criteria, novel site placement, and recruitment approaches.
Moreover, education of healthcare providers and community outreach to build trust and increase clinical trial awareness can directly help address recruitment, enrollment, and retention of a diverse clinical trial population. In addition, these strategies will also expand access to investigational treatments for underserved populations.
Similarly, educational approaches using culturally and linguistically responsive curriculum developed in partnership with communities we are seeking to serve is an imperative. Additionally, we must recruit and retain clinical trial personnel with diverse backgrounds – including racial and ethnic backgrounds. A pool of diverse investigators, staff, and research directors can serve as a trusted and knowledgeable source of information for underrepresented diverse populations.
We also must improve individual health literacy. Educational efforts also should be aimed at increasing access to quality healthcare and reducing barriers for underrepresented and diverse populations to receive healthcare they need. Increased participation in clinical trials will be a byproduct of increased access to quality care. Viewed from this perspective, participation in clinical trials is a part of the quality healthcare fabric.
Proactive science-driven strategies to increase diversity among participants may include identifying sites where diverse patients at-risk for COVID-19 may be located, identifying healthcare providers that treat underserved or underrepresented populations, collaborating with investigators to address the goals of enrolling a diverse population, and face-to-face meeting with investigators and the community actors.
When designing clinical trials, investigators should consider recruitment challenges and enrollment barriers such as inconvenient planned visit schedules, inaccessible locations, financial implications, and how these factors might be addressed. For example, flexible scheduling, mobile units, food, child care, and utilizing digital technologies (e.g., FDA-approved electronic consent forms, mobile tools and wearable technologies to gather data from participants, decentralized or virtual trials) may help to encourage greater participation from diverse patient populations.
Furthermore, uncovering barriers to participation should use a patient-centered approach that takes into account patient input and experiences. Incorporating the patient perspective and taking into account the specific disease burden on patients’ and caregivers’ daily lives and activities (e.g., time commitment, time away from work, travel, caregiver responsibilities, status of the disease) help improve clinical trial designs, clinical trial access and participation, and recruitment, enrollment, and retention of diverse populations.
There are many organizations and agencies (e.g., Pfizer, NIH, FDA) that provide guidance to improve representation of communities of color and more importantly patient voices in clinical trials. For instance, the Patient-Centered Outcome Research Institute (PCORI) has outlined in Guidance on the Design and Conduct of Trials in Real-World Settings strategies to engage patients in clinical trial research with the goal of producing high quality and representative study findings that can be applied to health care.
Even after a vaccine is approved, real-world evidence can be used to enhance understanding of the heterogeneity of treatment effect, or lack thereof, for selected subgroups. This information should allow COVID-19 vaccine development programs to broaden the inclusion and exclusion criteria and improve enrollment of diverse populations in future clinical trials or post-marketing Phase IV studies (e.g., studies with pediatric and pregnant women populations).
During the post-marketing phase, collecting clinical real-world data/real world evidence may be an important method of supplementing trial data, in compliance with all applicable local laws and regulations, serving as an effective and efficient means to enhancing understanding of drug responses in diverse patient populations.
Also, post-marketing findings should be disseminated to the community through established partnerships with providers, community-based organizations and faith-based institutions – thereby closing the learning loop. Furthermore, feedback from the community on interpreting post-approval findings should play a key role in shaping ongoing and future COVID-19 vaccine clinical trials.
Finally, policies or statement(s)/information about diversity, equity, and inclusion (DEI) practices should be available on public websites of individual company’s (e.g., Pharma, Clinical Research Organizations) and hospitals. Post-marketing materials describing efforts and outcomes to increase participation of underrepresented populations in clinical trials, broaden eligibility criteria when scientifically and clinically appropriate, and patient-centric medical development programs should be included in dissemination.
In sum, the COVID-19 vaccine clinical trial process is complex and lengthy, and without volunteer participation, the development of new COVID-19 vaccines would not be possible. Access to quality healthcare as well as participation in clinical trials (when at all feasible) should be a goal of public health. As important, participation in COVID-19 vaccine clinical trials by communities of color increases community trust, improves vaccination rates, and decreases disease burden.
Anthony Salandy, Ph.D., M.S.
Dr. Salandy is founder of the Institute for COVID-19 Vaccination Advocacy (ICVA). ICVA aims to increase knowledge of the COVID-19 vaccination program, decrease COVID-19 vaccine hesitancy, and improve COVID-19 vaccine coverage around the globe.