Diverse clinical trials are a matter of equity and essential for the validity and reliability of research outcomes. Historically, racial and ethnically minoritized groups or populations have been excluded from clinical trials, leading to a lack of data on how different demographic subgroups respond to treatments. The Clinical Trials Transformation Initiative (CTTI) aims to change this narrative by developing recommendations and driving the adoption of practices that support inclusivity and representativeness of all patient populations in clinical research.
Recently, Xtalks had the opportunity to speak with Sabrena Mervin-Blake, Senior Project Manager at CTTI, who has been leading efforts to enhance diversity in clinical trials. In this interview, Mervin-Blake shares the insights and strategies that CTTI has identified to make this vision a reality.
XTALKS CLINICAL EDGE: Issue 3 — Interview with CTTI
Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. This magazine immerses you in a world where industry leaders, patient advocates and top researchers converge to provide the most insightful perspectives on clinical trials.
Organizational-Level Practices for Increasing Diversity
Mervin-Blake outlined four primary organizational strategies identified by CTTI to foster diversity in clinical trials: commitment, partnerships, resources and accountability.
- Commitment: This involves a top-down approach where leadership and organizational culture prioritize diversity. Strong commitment from senior leadership is essential to drive the development and implementation of programs that enhance equitable access and diverse participation in trials. This also entails embedding diversity, equity and inclusion (DEI) principles into the organization’s culture and research strategy.
- Partnerships: Building robust, bidirectional partnerships with community and patient groups is critical. It is essential to listen to these voices throughout all stages of the research process to ensure trials are designed and implemented in a way that is inclusive and relevant to diverse populations.
- Resources: Developing the necessary infrastructure with sustained funding and dedicated personnel at all levels is crucial for creating and maintaining diverse programs. Ensuring that diversity initiatives are well-supported financially and organizationally can lead to more consistent and effective implementation.
- Accountability: Using data-driven strategies to monitor and measure recruitment and retention of diverse populations helps organizations assess the effectiveness of their diversity efforts. Continuous evaluation and willingness to adjust strategies based on data are key to achieving long-term success.
Incentives (and Disincentives) for Promoting Inclusive Trials
Promoting diversity in clinical trials brings both incentives and challenges. One major incentive is the potential for more accurate and generalizable results. Including a wide range of demographic subgroups ensures treatments are effective across different groups, improving access to innovative therapies for all populations. “It also develops trust in clinical trials results and facilitates uptake if a medical product is approved,” Mervin-Blake noted.
Additionally, diverse trials lead to more comprehensive treatment guidelines, particularly for those disproportionately affected by certain diseases. Organizationally, promoting diversity can lead to greater efficiency and resource allocation. Establishing broad, sustainable relationships and strategies at the program level, rather than on an individual study basis, reduces duplication of efforts, saving time and resources.
However, there are significant challenges. The perception that diversity strategies will increase costs and extend timelines is a primary disincentive. Changing established practices requires significant investment in planning, funding and personnel. Organizational resistance to change can also be a barrier, as shifting to new diversity practices necessitates altering business strategies and reallocating resources.
Organizations might find it challenging to commit to changes that initially seem more demanding. Yet, as Consuelo H. Wilkins, an American physician, biomedical researcher and health equity expert, stated, “While this new way of doing things may be a little bit challenging, it’s not hard; it’s just different,” Mervin-Blake emphasized. Developing and implementing new diversity strategies requires detailed business planning and a willingness to rethink resource use, which can be a hurdle for those accustomed to routine practices.
Addressing Disincentives Through Stakeholder Collaboration
Addressing the disincentives associated with promoting diversity in clinical trials requires a concerted effort across the clinical research ecosystem. Mervin-Blake highlighted how CTTI collaborates with various stakeholders to overcome these challenges and foster a more inclusive research environment.
CTTI works with experts across the clinical trials enterprise to identify challenges and develop practical solutions. Their diversity recommendations and maturity model offer organizations clear guidance and best practices to support organization-level DEI efforts. These tools help organizations assess their current state, identify areas for improvement and implement effective diversity strategies.
A significant initiative is the Diversity Convergence project, which brings together multiple organizations, including the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, FasterCures, a center of the Milken Institute and the National Academies’ Forum on Drug Discovery, Development and Translation. This collaboration resulted in a national action plan for achieving diversity in clinical trials, outlining key domains and collective actions for the clinical trials enterprise to commit and implement.
“The idea with convergence is that we are working on things that one organization or one group couldn’t do on its own, and it takes the converging of multiple groups and stakeholders to come together and build on one another’s work,” Mervin-Blake explained.
Another effort is the Enabling Networks of Research Infrastructure for Community Health through Clinical Trials (ENRICH CT) initiative, initiated by the Milken Institute. This group, which includes representatives from across the research enterprise, meets regularly to share best practices and discuss ways to build on existing networks and systems to bring research closer to communities.
Additionally, CTTI is currently developing a project team to address challenges around the implementation of diversity action plans as referenced in the recently released updated FDA draft guidance, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This project will result in recommendations and/or tools to support organizations in the implementation of action plans, aligning with the new guidance.
Measuring Success in Diversity Efforts
Measuring the success of diversity efforts in clinical trials is essential to ensure that strategies are effective, and goals are being met. Mervin-Blake explained that CTTI had developed a diversity maturity model to help organizations assess their current infrastructure for improving diversity in clinical trials and review progress towards a desired future state. This model includes stages that guide organizations from initial commitment to full integration of diversity practices.
According to Mervin-Blake, the key metrics for measuring success include:
- Representation Accuracy: Assessing whether trial participants accurately reflect the population’s demographics affected by the disease or condition.
- Outcome Relevance: Evaluating if diverse populations respond differently to treatments, as existing data already shows variations in responses across different demographics.
- Generalizability: Determining if results from a diverse participant group can be applied more broadly across various populations outside the trial.
- Scientific Validity: Ensuring that diverse genetic backgrounds are considered, which can influence how patients metabolize drugs and respond to therapies.
- Regulatory Compliance: Meeting guidelines set by regulatory bodies that may require the inclusion of diverse populations for approval.
On an organizational level, developing robust measurement methods and being transparent about these measures is crucial. Organizations need to create and share their metrics to foster a culture of continuous improvement and learning across the clinical trials enterprise. Examples of existing measures include the US Food and Drug Administration’s (FDA) Drug Trials Snapshots and the Good Pharma Scorecard, which use the participation to prevalence ratio (PPR) to compare the representation of specific populations in studies.
Mervin-Blake emphasized, “We need more measurements, and we need more organizations to develop measurement methods and then be transparent about their measures, not just keeping it within their own organization, so others can learn.” While there are some existing tools, more comprehensive and widely applicable measurement methods are needed. This will help organizations track their progress and make data-driven decisions to improve diversity in clinical trials continually.
Future Goals and Milestones for Inclusive Trials
CTTI’s vision for the future of clinical trials is to ensure that participants accurately represent the diversity of the population using medical products. This aligns with their broader goal to make clinical trials patient-centered, accessible and integrated into healthcare processes by 2030.
A goal is to embed DEI principles into clinical trial design and execution. This involves developing comprehensive recommendations and best practices that can be adopted industry-wide, ensuring diversity is fundamental to research planning and implementation.
“The overall work is to achieve representative outcomes that accurately reflect the populations we aim to serve,” Mervin-Blake emphasized.
Looking ahead, through the Measuring Trials Transformation project, CTTI aims to develop standardized metrics and encourage transparency in reporting progress, including metrics on diversity and representation in clinical trials. By fostering a culture of accountability and continuous improvement, CTTI hopes to drive meaningful change across the clinical trials landscape.
Increasing diversity in clinical trials is a complex but essential endeavor. CTTI is paving the way for more inclusive and representative clinical research through organizational commitment, strategic partnerships, adequate resources and accountability. By addressing disincentives and fostering collaboration, CTTI aims to create a clinical trial environment where diverse populations are not just included but are integral to the research process.
Mervin-Blake’s insights highlight the importance of these efforts and the tangible steps organizations can take to achieve greater diversity in clinical trials.
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