FDA Guidance Summary
The U.S. Food and Drug Administration (FDA) has issued a draft guidance titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” This guidance aims to help medical product sponsors submit Diversity Action Plans to enhance the inclusion of historically underrepresented populations in clinical studies. Increasing diversity in these studies ensures that the data collected is more representative of the patients who will use the medical products, improving the understanding and safe usage of these products. The guidance, which applies to some phase 3 trials, replaces an earlier, less detailed guidance document issued in April 2022.
“Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf, M.D. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.”
The draft guidance outlines the required format and content of Diversity Action Plans, the relevant medical products and clinical studies, as well as the timing and process for submission to the FDA. It also details the criteria for evaluating requests to waive the submission requirement. Diversity Action Plans must include the sponsor’s rationale and goals for enrollment based on age, ethnicity, sex, and race, and should consider other dimensions of diversity relevant to the patient population.
This requirement stems from the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Omnibus Reform Act (FDORA). It applies to phase 3 and other pivotal clinical studies, as well as certain device studies, with enrollment beginning 180 days after the final guidance publication.
“Generating data for a broader and more representative population early in the clinical development program is among the FDA’s priorities to bring innovative medical products to the public. With FDORA, there is now a requirement for sponsors to submit diversity action plans. These plans may help ensure that sponsors are thinking critically and intentionally about the many characteristics of the patient population they aim to treat when designing their clinical study,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.”
The draft was developed by the Oncology Center of Excellence Project Equity in collaboration with various FDA centers and offices, including the Office of Women’s Health and the Office of Minority Health and Health Equity.
How mdgroup Supports Trial Diversity
ondemand services
Through ondemand services, participants receive personalized concierge support, compliant travel, accommodation, logistics, and expense management and reimbursements. This comprehensive support system addresses many of the practical challenges that potential participants face, such as coordinating travel, finding suitable accommodation, and managing related expenses. By offering these tailored services, mdgroup removes significant barriers to participation, particularly for individuals from underrepresented populations who may struggle with logistical and financial constraints.
This not only facilitates easier access to clinical trials for a diverse range of participants but also ensures that their involvement is seamless and stress-free. The enhanced convenience and support provided by ondemand services contribute to more inclusive and representative clinical trials, fostering the development of medical treatments that are effective and safe for all demographics.
mobilehealth services
mdgroup further enhances clinical trial diversity through its innovative mobilehealth services, which play a critical role in broadening the demographic reach of clinical trials by facilitating decentralized and home-based studies. By enabling patients to participate from their homes, mdgroup eliminates barriers that traditionally restrict trial participation to a limited demographic. This approach facilitates the involvement of individuals from diverse geographic locations, socioeconomic backgrounds, and cultural contexts, thus ensuring a more representative sample of the population.
These services are particularly beneficial for underrepresented groups who often face significant challenges, such as travel difficulties, financial constraints, and demanding time commitments. By removing the necessity to travel to clinical sites, these services make it feasible for more individuals to partake in clinical research, including those who might otherwise be excluded due to logistical hurdles.
Why Diversity Matters
The inclusion of a broader participant pool leads to the collection of more comprehensive and generalizable data, enhancing the relevance and impact of medical research. This diversity ensures that the findings from clinical trials are applicable to a wider range of populations, thereby improving the development of medical treatments and interventions that are effective and safe for people of all backgrounds. Researchers can identify potential differences in drug efficacy and side effects by considering the responses of various ethnicities, genders, ages, and socioeconomic statuses, ultimately contributing to more personalized and equitable healthcare solutions. mdgroup services significantly advance clinical trial diversity, fostering an inclusive research environment that benefits all populations and drives forward the future of healthcare.
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From the initial design of patient-first protocols to the final stages of visit planning, scheduling, and management, our services encompass every aspect of the clinical trial journey.
