The U.S. Food and Drug Administration recently announced a new requirement for researchers and companies to submit a plan for ensuring diversity among clinical trial participants. At FSG, we’ve been working with life science companies on health equity strategies for several years, and we’re excited to see this announcement taking us one step closer to standardizing a more expansive approach to how clinical trials are conducted.
We know that ensuring people from diverse backgrounds are represented in clinical trials is key to advancing health equity. When researchers fail to enroll a diverse study population in clinical trials, they are prevented from gaining a thorough understanding of how new drugs and medical products will work for a range of patient populations. Non-white communities make up nearly 40% of the U.S., but their inclusion rate in clinical trials ranges from 2% to 16%. This costs companies when therapeutics’ safety and efficacy information is not fully generalizable and results in lost revenue from not reaching historically underserved populations.
We’re thrilled to see this announcement from the FDA, which supports more life science companies making progress towards diversity in clinical trials as part of their broader commitments to health equity. As Dr. Thomas Hwang, a physician at the Dana-Farber Cancer Institute, pointed out in a Nature journal article, “This is the biggest change in the regulatory landscape for clinical-trial diversity in the last three decades.”
Life science companies can prepare for these new requirements now by taking additional steps to build more inclusive research and development (R&D) processes and integrate a health equity lens throughout their entire product lifecycle.
Expanding Inclusive R&D
While the FDA’s new requirement for formalizing diversity in clinical trials is one important step in standardizing inclusive research practices, diversity plans alone are not enough to drive equitable health outcomes. While population diversity will improve in clinical trials as a result of this requirement, some subgroups within historically marginalized communities may still not be equally represented. Bias and exclusion in study protocols may occur and limit generalizability by failing to take into account specific comorbidities or conditions.
Life science companies can take further steps to address recruitment challenges and barriers to participation in clinical trials, most often associated with deeper structural and systemic factors. Companies can expand from simply increasing diversity in clinical trials to building more comprehensive, inclusive R&D processes.
Companies should consider these five questions to build more inclusive R&D processes:
- Where are trials located? Bringing trials closer to patients’ homes, as well as digitizing and decentralizing trial locations, can improve the patient experience and increase enrollment and participation rates.
- How are patients supported? Understanding the social and community context for a range of diverse patient populations and addressing travel, language, and financial barriers can help reduce the burden of clinical trial participation for patients and improve enrollment and retention.
- How are patients treated? It is important to consider how patients are treated within clinical trials, in addition to thinking about who is included. Study protocols should be centered around patient needs and designed in collaboration with community stakeholders to address a lack of trust from patients and their communities.
- Who is conducting the research? Improving the diversity of research teams has a direct impact on the quality of innovation and the reduction of implicit bias in research. The best ideas occur in a diverse and inclusive workplace, and companies are missing out on a competitive advantage if principal investigators and research teams of diverse identities and backgrounds are not included.
- Are social determinants of health (SDOH) included in the research? Beyond biomedical factors that are the focus of the research, integrating non-medical factors such as SDOH that drive up to 50% of health outcomes through systematic data collection and analysis can help better take into account patients’ socioeconomic context and its influence on treatment response.
Integrating a Health Equity Lens throughout the Product Life Cycle
Inclusive R&D is only one dimension of what companies can do to improve health equity. It’s important that companies intentionally integrate a health equity lens at all stages of the product life cycle, from preclinical all the way through to commercial strategy and distribution.
Companies should consider these questions to integrate a health equity lens at other stages of the product life cycle, beyond clinical trials:
- How do we determine research priorities? Including the patient and community voice in preclinical stages can help companies advance inclusion in clinical stages. Companies can also include diversity, equity, and inclusion principles in risk assessment tools and decision-making criteria.
- How can medical affairs teams counter bias and improve clinical care quality for marginalized populations? Medical affairs teams can work with health care providers to increase awareness of how bias shows up in health care (e.g., race correction in clinical algorithms) and to improve the quality of care for historically underrepresented and marginalized populations.
- Who is accessing our products? Data disaggregation can help life science companies understand who is currently accessing their products, who is not, and who may be overlooked by targeting approaches.
- How is health equity incorporated into brand planning and commercialization strategies? Learning from more inclusive clinical trials can help brand planning and commercialization teams develop specialized strategies for reaching populations that are historically overlooked or undervalued by traditional sales targeting approaches.
- Are marketing materials accessible across patient populations? Rethinking language, format, word choice, and distribution channels can help reduce barriers faced by populations experiencing inequities in health care.
- How can partnerships with other stakeholders reduce barriers to care? Collaborating with patient advocacy groups, peer companies, payers, and academic institutions can help life science companies address some of the systemic and structural challenges to health and health care. For example, formulary requirements by payers (e.g., prior authorization, step therapy) can unintentionally create larger barriers for some patient communities who may face bias or other challenges in accessing prior steps before a life-saving therapy.
The FDA’s landmark announcement formalizing diversity in clinical trials represents an important step in the journey to advance health equity, in both supporting companies seeking to improve the representation of historically underserved populations in clinical trials and promoting equitable health outcomes and innovation in health care.
FSG is here to help as your company considers how to prepare for these new legal requirements and beyond. Before the requirement takes full effect, the FDA will be finalizing its draft guidance and offering the public an opportunity to comment—a process that can take up to two years.
In the meantime, life science companies have the opportunity to be proactive. Once the new requirement is implemented, it will be up to companies and researchers to meet enrollment targets and address the structural problems that underlie the lack of diversity in clinical trials. Smart companies can invest now in strengthening their strategies and processes to prioritize health equity within and beyond R&D.
We are keen to hear what you are learning* as you integrate diversity plans into clinical trials and other efforts to advance health equity and push the conversation in the industry. FSG is committed to helping embed health equity in life science strategies and processes.
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