Why is diversity in clinical trials so important? Anju’s Vice President of Product Management Laura Acosta analyses this below. Her commentary was recently featured in a Clinical Research News article. Read her full, comprehensive analysis below.
Clinical trials are pivotal in propelling medical research forward and enhancing the quality of patient care. Yet, for an extended period, a conspicuous absence of diversity within clinical trial participants has been observed, leading to the underrepresentation of specific demographics and the possible emergence of healthcare disparities. In response to this pressing need for transformation, visionary legislation like the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act has been introduced, aiming to tackle these challenges head-on and champion inclusivity within clinical trials.
Understanding the DEPICT Act
The DEPICT Act, introduced by Rep. Anna G. Eshoo (D-CA), Rep. Brian Fitzpatrick (R-PA), and Rep. Robin Kelly (D-IL), aims to strengthen diversity in clinical trials through enhanced data reporting and increased resources for underrepresented communities. The act requires Investigational New Drug (IND) and Investigational Device Exemption (IDE) applicants to report clinical trial enrollment targets by demographic subgroup, including age, race, ethnicity, and sex. These targets should be accompanied by a Diversity Action Plan outlining strategies for reaching enrollment goals and improving diversity.
In addition, the DEPICT Act grants the FDA the authority to mandate post-market studies when sponsors fail to meet diversity enrollment targets without sufficient justification. The FDA is also required to publish an annual report analyzing the data provided by sponsors on their progress toward improving diversity in clinical trials.
The Need for Diversity in Clinical Trials
Diversity within clinical trials serves as a paramount imperative for multifaceted reasons. Foremost among these is the assurance that medical products undergo rigorous testing on a representative cross-section of the population they intend to benefit. Diverse populations often exhibit unique genetic variances or distinct physiological responses to treatments. The absence of comprehensive diversity in clinical trials can leave gaps in our understanding of the efficacy and safety of medical products.
Embracing diversity in clinical trial participation stands as a significant step toward addressing persistent health disparities. Certain diseases disproportionately impact specific demographic groups. By actively engaging a diverse range of participants in clinical trials, researchers can amass essential data to formulate precisely targeted treatments and interventions for these marginalized communities. This pivotal approach paves the way for more equitable healthcare outcomes and a substantial reduction in healthcare disparities.
The Impact of Underrepresentation
Historically, certain populations, including racial and ethnic minorities, have been underrepresented in clinical trials. This underrepresentation has led to a lack of data on how treatments and interventions affect these populations, resulting in potential gaps in our understanding of their health needs. For instance, despite their significant presence among cancer cases, the enrollment of Black Americans in clinical trials has remained disproportionately low.
The absence of a diverse participant pool poses the risk of developing medical products that are less effective or have unintended adverse effects in underrepresented populations. This can perpetuate health disparities and limit access to appropriate treatments for marginalized communities.
The Role of Pharmaceutical and Biotech Companies
Pharmaceutical and biotech companies play a crucial role in championing diversity in clinical trials. The DEPICT Act requires these companies to develop and submit diversity action plans, outlining their strategies for increasing diversity in their trials. These plans should include demographic-specific outreach and enrollment strategies, study-site selection, and diversity training for trial personnel.
Through the proactive execution of diversity action plans, pharmaceutical and biotech companies can surmount barriers to participation, cultivate meaningful connections with historically underrepresented communities, and, in turn, foster a more inclusive landscape within their clinical trials. Such endeavors reap benefits not only for the participants themselves but also elevate the overall caliber and dependability of research findings and outcomes.
The FDA’s Role in Ensuring Diversity
The FDA has a critical role in advancing diversity in clinical trials. As the regulatory authority entrusted with assessing and endorsing medical products based on their safety and effectiveness, the FDA recognizes the importance of encompassing a diverse participant pool to uphold the integrity and applicability of clinical trial outcomes.
The DEPICT Act empowers the FDA with the authority to scrutinize diversity plans submitted by sponsors and establish accountability for achieving diversity enrollment objectives. The agency will also publish periodic reports to Congress on approved therapies, highlighting the diversity of participants in the clinical trials. These initiatives foster transparency and serve as a catalyst for sponsors to prioritize diversity in their trial design and recruitment endeavors, promoting more inclusive and representative clinical research.
Overcoming Barriers to Diversity
Enhancing diversity in clinical trials requires addressing various barriers that contribute to underrepresentation. One significant barrier is the lack of awareness and trust within underrepresented communities. Within these communities, individuals may lack knowledge about clinical trials or harbor reservations about participating due to past mistreatment or insufficient access to relevant information.
To overcome these barriers, community engagement and outreach efforts are crucial. The DEPICT Act provides funding to the National Institutes of Health (NIH) for community engagement initiatives and grants to Community Health Centers to increase their capacity to participate in clinical trials. These efforts are designed to establish trust, impart education to communities, and augment awareness regarding the tangible benefits of engaging in clinical trials.
The Society for Clinical Research Sites (SCRS) also provides a Diversity Site Assessment Tool (DSAT) to help clinical trial sponsors in developing Diversity Action Plans. Additionally, specialized software tools, including several from Anju, provide seamless integration of diversity data. This enables users to efficiently manage Key Opinion Leader (KOL) selection, Principal Investigator (PI)/site selection, and diversity strategies while reviewing experience, diversity, and socioeconomic data within a single interface.
Sponsors can further enhance their clinical trials through electronic patient-reported outcome (ePRO) and Clinical Trial Management Software systems that deliver modules to ensure patient engagement designed to help patients remain compliant to certain clinical trial requirements. These systems include modules designed to boost patient engagement and ensure compliance with trial requirements.
Public Workshops and Collaborative Efforts
The FDA plays a pivotal role in facilitating public workshops to assess the impact of clinical trial flexibilities and their effect on improving access to trials in underserved populations. These workshops provide an opportunity for stakeholders, including industry leaders, researchers, and community representatives, to share best practices and innovative strategies for engaging diverse populations.
Collaboration between industry, research sites, regulators, and community organizations are crucial for achieving meaningful progress in increasing diversity in clinical trials. By sharing knowledge, resources, and experiences, these stakeholders can collectively work towards creating a more inclusive and equitable research environment.
The Future of Clinical Trial Diversity
The introduction of legislation like the DEPICT Act marks a significant step towards improving diversity in clinical trials. By requiring enhanced data reporting, diversity action plans, and increased resources, this legislation aims to address the historical underrepresentation of certain populations.
Promoting diversity in clinical trials is an ongoing effort that requires continuous commitment and collaboration. It is essential for pharmaceutical and biotech companies, healthcare providers, regulators, and community organizations to work together to eliminate barriers, increase awareness, and ensure equitable participation in clinical research. Only through such collective efforts can we improve healthcare outcomes for all populations and advance medical knowledge in a truly inclusive manner.
Through the enforcement of diversity requirements and the insistence on sponsors conducting trials with diverse patient populations, the overarching objective is to bring forth drugs and devices to the market that exhibit enhanced safety and efficacy across a broader spectrum of individuals. We are optimistic that these diversity mandates will play a pivotal role in fostering a more equitable distribution of healthcare and ultimately lead to improved outcomes. This positive transformation holds the potential for significantly heightened survival rates, particularly among patient demographics that have historically encountered limited access to clinical trials.
Conclusion
Incorporating diversity within clinical trials transcends mere considerations of fairness and equity; it is an imperative for advancing healthcare outcomes across all demographic groups. The DEPICT Act, along with complementary initiatives, endeavors to champion diversity in clinical trials through mandates for comprehensive data reporting, the formulation of diversity action plans, and augmented resource allocation. By actively dismantling barriers, engaging with underrepresented communities, and nurturing collaborative efforts, we can pave the way for heightened diversity in clinical trials and, in turn, elevate the quality of healthcare for every individual. Embracing this opportunity and collaborating across all stakeholder groups is pivotal in collectively shaping a research landscape that is more diverse and inclusive.
Laura Acosta is a seasoned software development professional. In her current position as Vice President of Product Management at Anju Software Ms. Acosta is responsible for the product direction of the eClinical suite at Anju Software including TrialMaster and CTMS Master. Prior to Anju, she worked at Oracle in the Health Sciences Global Business Unit for over 23 years, holding roles such as Product Director, Principal Product Manager and Senior Software Development Manager. Before joining Oracle, Laura served as Software Development Manager at NovaSoft and was a Software Development Manager at Raytheon Missile Systems. Ms. Acosta earned a Bachelor of Science (B.S.) degree in Computer Science from Tufts University and a Master of Science degree in Computer Science from Boston University.