This past April, the FDA released updated guidance to sponsors and pharmaceutical companies on increasing racial and ethnic diversity in clinical trials to propel more inclusive research. Racial and ethnic minorities have historically been underrepresented in research,1 even within diseases where they make up the majority of those affected. The FDA also advises sponsors to “seek diversity in clinical trial enrollment beyond populations defined by race and ethnicity, including other underrepresented populations defined by demographics such as sex, gender identity, age, socioeconomic status, disability, pregnancy status, lactation status, and co-morbidity.“2 This, in part, reflects a broader issue regarding inequitable access to health care and centers that conduct clinical research programs. Ultimately, diverse and inclusive study populations will help drive better outcomes across the entire population.
The FDA further recommends that sponsors develop a plan to outline the operational measures that will be implemented. This plan should include a “specific plan of action to enroll and retain diverse participants.” Here, we highlight 3 opportunities for sponsors to address the FDA’s guidance.
1. Design the protocol to be inclusive
Research shows that LGBTQIA+ individuals experience numerous health disparities and barriers connected to gender identity and sexual orientation.3 Think about the study design as the blueprint for your clinical trial. The FDA draft guidance “underscores the importance of prospectively defining the approach to generating data for a broader and more diverse population early in the development program.”4 In a review of 40 recent study protocols within the CRIO site-based eSource platform, 10% had gender-inclusive definitions, while the rest simply offered a binary choice of gender without any explanation or definition.5 Consider including gender-inclusive language in the early stages of building the protocol.
“The protocol should build in taxonomies and/or guidelines that specify how investigators should classify individuals who identify with a gender different from the sex assigned at birth,” explains Raymond Nomizu, CEO at CRIO. “Lack of inclusive language creates unnecessary ambiguity and leads to datasets that are misaligned with other datasets collected within the healthcare world. That’s because most EHR systems are now embracing gender inclusivity.”
Other examples that build trust and remove barriers to study participation include financial reimbursements for trial participation expenses, as well as involving communities, patients, and caregivers in the design of the trial protocol. To boost patient enrollment, sponsors may additionally need to consider identifying, selecting and operationalizing new sites.
2. Identify, select and operationalize new sites
The FDA’s guidance recommends, where appropriate, that sponsors broaden eligibility criteria to improve clinical trial participation. To support enrollment and diversity targets, sponsors may need to rapidly start-up new sites to include locations with higher concentrations of minority patients. Working with research-naive sites can be challenging for sponsors. Standardizing new sites on an electronic solution, like eSource, streamlines workflows, ensures data precision, and reduces administrative burdens, giving sites more time to focus on recruiting and retaining patients.
“Standardization of the initial source reduces the workload for both sites and CRAs. This ensures that critical data points are not missed,” says Takoda Roland, Clinical Research Consultant. “This increases the likelihood of noticing trends across sites. With site-based eSource, standardization is easier to manage with protocol amendments and clearer version control.”6 The plan should also include methods to reduce trial burdens for sites and participants.
3. Reducing trial burden for both sites and participants
Telehealth offers advantages in accessible care, increased convenience, and a more nuanced consideration of social circumstances, all of which could reduce barriers to clinical trial access for rural and diverse communities. Telehealth visits are also significantly shorter than in-person visits, saving time for both sites and patients. A 2020 study reports that on average, a Telehealth visit could save a participant as much as 3 hours of time and 100 miles of travel per visit.7
Telehealth can enable flexible, hybrid trials designed to meet patients anywhere, at any time. Creating participation flexibility, and reducing or eliminating the frequency of study visits, could reduce travel burden and clinical costs. These considerations will help expand outreach to communities with limited access to health centers.
Sponsors should meet with potential vendors early in the strategy planning process. Assess how their eClinical solutions can address inclusion, diversity and non-traditional study designs. Look for vendors who can demonstrate industry experience, are transparent about their capabilities, and provide accurate estimations on timelines and deliverables. For more information on increasing diversity in clinical trials, read “It’s not about DCT – Diversity Driven Trials are Key,” with Jonathan Andrus, industry thought-leader, president and COO at CRIO.
Read: The CRIO Model
1 “Representation in Clinical Trials: A Review on Reaching Underrepresented Populations in Research,” Clinical Researcher, August 2020 (Volume 34, Issue 7) https://acrpnet.org/2020/08/10/representation-in-clinical-trials-a-review-on-reaching-underrepresented-populations-in-research/.
2 “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry,” Food & Drug Administration (April 2022) https://www.fda.gov/media/157635/download#page=5.
3 Miriam M. Moagi, Anna E. van Der Wath, Priscilla M. Jiyane, and Richard S. Rikhotso, “Mental health challenges of lesbian, gay, bisexual and transgender people: An integrated literature review,” January 20, 2021 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7876969/
4 “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry,” Food & Drug Administration (April 2022) https://www.fda.gov/media/157635/download#page=5.
5 Nomizu, Raymond, JD, “CRIO’s Patient Recruitment is Now Gender Inclusive,” CRIO Blog, November 2021 https://clinicalresearch.io/blog/patient-recruiting/crios-patient-recruitment-system-is-now-gender-inclusive/
6 Roland, Takoda, “Leveraging eSouce as a Study Manager for Remote Monitoring,” Last modified October 2022 https://clinicalresearch.io/blog/running-a-study/leveraging-esource-as-a-study-manager-for-remote-monitoring
7 Dorsey, E. Ray; Okun, Michael S.; Bloem, Bastiaan R., “Care, Convenience, Comfort, Confidentiality, and Contagion: The 5 C’s that Will Shape the Future of Telemedicine,” Journal of Parkinson’s Disease, vol. 10, no. 3, pp. 893-897, 2020, July 28, 2020 https://content.iospress.com/articles/journal-of-parkinsons-disease/jpd202109