In an ongoing evolution of equitable clinical trials, as of June 26, 2024, the FDA has issued a draft guidance, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies, providing new details on Diversity Action Plans required for certain clinical studies. Below, our DEI and clinical trials experts explore the evolution of health equity in clinical trial regulations and what this evolution means for the industry moving forward. 

The regulatory landscape for clinical trials in the United States has evolved significantly over many years, showcasing a commitment to ongoing improvement, and establishing comprehensive laws and regulations to shape the field. Globally, expectations and standards for the medical community are consistently raised, striking a delicate balance between the necessity for increased regulations and the imperative for advancements in medical research. 

Nevertheless, the prevalence of medical mistrust is both real and understandable, stemming from the historical track record of the U.S. and unethical events within medical research, particularly impacting marginalized groups. In this piece, we provide a deep dive into the evolution of health equity in clinical trial regulations. 

Fostering a More Inclusive Clinical Trial Landscape

Trust in clinical research is paramount; the healthcare/pharmaceutical industry has struggled in the past but has recently begun focusing on initiatives to restore trust, such as increased transparency, fostering diverse staff, utilizing digital marketing techniques, and strengthening community relations. Improving standards in clinical research directly contributes to higher-quality care by improving study outcomes and producing more reliable data.  

By implementing culturally relevant marketing and transparent practices, companies enhance study demographics, fostering patient trust and contributing to a more representative sample – ultimately aligning with evolving regulatory standards for elevated patient care. Below, we explore the historical trajectory of clinical trial regulations, offering essential context for recent updates enacted into law last year. 

Historical Advancements in Clinical Trial Regulations 

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Starting with the landmark Drug Importation Act of 1848 through the 2022 Food and Drug Omnibus Reform Act (FDORA), the advancements in clinical trial regulation has continued to focus on improved ethical standards and transparency. Major events in clinical research like the 1932-72 Tuskegee Study, the 1947 Nuremberg Code, and the 1962 Kefauver-Harris Amendment are all associated with terrible conduct by the research community. These regulations, however, have also laid the groundwork for major protections for patients/participants, driving the concept of informed consent, the idea of beneficence, and the need for proof of efficacy and safety.  

Government intervention has often been vital to curbing poor behavior, i.e., the National Research Act of 1974 and the Belmont Report of 1979, providing the necessary protections for study participants’ trust and well-being. It’s difficult to think of where medical research would be without the FDA and DHHS stepping in to enact initiatives like the 1997 ICH E6 Good Clinical Practice (GCP) guidelines and the 2007 FDA Amendments Act, which helped to increase participant confidence and the reliability of the results reported. 

These historical efforts have resulted in a much safer and more productive research environment. However, it can’t be denied that with regulation comes potential hurdles to innovation. Therefore, it’s critical to understand when regulations or legislation are necessary and when they become a hindrance.  

Much like many of the examples cited above, we are long overdue for the regulations introduced by the 2022 Food and Drug Omnibus Reform Act (FDORA), which emphasizes modernization, diversity, and flexibility in clinical trials. FDORA introduces critical updates, focusing on two vital aspects: Clinical Trial Diversity and Clinical Trial Flexibility.  

1. Clinical Trial Diversity: 

 The focus of this portion of the legislation is to introduce a mandate for all Phase 3 and/or pivotal studies to create and maintain a Diversity Action Plan, requiring a strategic approach to enhance diversity. Plans encompassing enrollment goals and strategies are submitted with the study protocol. The FDA may waive the requirement based on disease prevalence or impracticality. Guidance on Diversity Action Plans ensures a standardized approach and promotes consistency and transparency. Public workshops and annual reports are integral components, soliciting input, fostering communication, and monitoring progress. 

This appears to be building off earlier legislation that passed in 2012 (FDASIA). There is an interesting opportunity here to take this one step further and mandate demographic analysis to be prominently displayed on clinicaltrials.gov and/or when submitting the final paper to PubMed (both of which are already mandated by the FDA – 2007 FDA Amendment, and 2008 NIH public access policy).  

2. Clinical Trial Flexibility: 

The other key focus of this legislation is the modernization of clinical trials, specifically adding provisions on clinical trial flexibility for an evolving research landscape. Draft guidance on decentralized clinical studies and the use of digital health technologies reflects a commitment to innovation while maintaining rigorous oversight. Collaboration with foreign regulators underscores the global nature of clinical research and the importance of harmonized standards. 

Looking Ahead 

The Food and Drug Omnibus Reform Act (FDORA) represents a milestone in the ongoing journey to enhance ethical conduct, transparency, and inclusivity of clinical trials. Its provisions for diversity action plans and flexible trial designs underscore a commitment to adapting to the evolving landscape of clinical research.   

As the FDA actively implements FDORA’s provisions, it will be critical for leadership to work with experts to stay informed of the latest guidance and help create and enhance existing community relations and marketing efforts while building out digital and analytic capabilities to meet the needs of the changing landscape. The legacy of FDORA and the DEPICT Act extends beyond the legislation itself, encompassing collaborative efforts by researchers, regulators, and the public to advance the ethical and scientific foundations of clinical research. 

To chat more about health equity in clinical trials, visit our Equitable Clinical Trials page and connect with our team today. 

Contributions by Nick Charron