Trial sponsors have made efforts to address underrepresentation and promote Diversity, Equity and Inclusion (DEI) in clinical trials since the Federal and Drug Administration’s (FDA) 2016 guidance, but a new report released by the Government Accountability Office (GAO) still shows a continuous presence of major gaps in patient diversity. It begs the question: how do we ultimately achieve full representation and ensure accountability to uphold the promises we have made for patients?
As the industry transitions from receiving guidance to now having to abide by formal legislation requiring diversity action plans – moving from intention to action – sponsors will have to re-evaluate their processes and how to address this long, overdue industry challenge. If they don’t act now, it could cost them tens of millions of dollars to repeat trials to meet pre-agreed criteria and will also create delays in recruitment plans, getting new treatments to patients, and more.
Let’s discuss how sponsors must take a multi-pronged approach to achieve representative diversity in clinical trials, as it will not be accomplished by pursuing any one tactic. It will also discuss what sponsors must do to strive beyond the legal minimum and truly move the needle for more representation, including utilizing decentralized clinical trial (DCT) models, increasing data centralization and management, partnering with communities, and understanding the power of empathy.
Prioritizing DCT Design and Data Infrastructure
Leveraging modern, digital trial designs like DCTs is a key piece in this multi-pronged approach. DCT and hybrid trial designs incorporating flexible, local, and home-based data collection technologies and methods can eliminate geographical barriers for patients. Meeting patients where they are and building more flexibility can help to improve participation by lessening the time and opportunity costs it takes to be in a trial, reducing the overall patient burden.
However, DCTs significantly increase the amount of data sources in a given trial, making it critical for sponsors to first invest in building a stable, long-term data infrastructure to manage the new level of data flow. A Tufts study released in 2021 found phase III clinical trials generated an average of 3.6 million data points, a 300% increase from a decade prior. Given that DCT adoption has accelerated since the post-pandemic, we can expect that figure to rise as DCTs bring in continuous data streams from physiological monitoring, for example glucose levels or heart rate, along with potential for RWD, EHR, eCOA/ePRO and other data from mobile trackers and devices.
A centralized clinical data platform that can standardize and streamline clinical data into a single source of truth is a crucial piece of efficient infrastructure in this data-heavy environment. This foundation enables researchers to confidently use the data, react in real time, and prepare diverse clinical data sets for review, analysis and submission, while also measuring results against their diversity plans.
By prioritizing infrastructure, it will also enable successful data orchestration and data fluency. Unlocking intelligence from combined information across different data sources such as electronic health records and labs necessitates an architecture equipped to merge disparate data sources and generate analytics.
Pharma companies must leverage the right tools to extract actionable insights from the most pertinent data, not only make trial pivots as needed but also to understand patients’ barriers to trial access and determine how to better engage them. From there, sponsors can better provide the appropriate support needed, whether that be transportation, expenses, or offering more remote options.
Improved data centralization and orchestration will not only allow pharma companies to diversify outreach to different sub-populations but also fuel the industry to have better conversations – with each other and with patients.
Driving Health Equity Through Community and Education
In addition to having the right tools, there are other ways sponsors can address underrepresentation in clinical trials. By partnering with local organizations within diverse communities, pharma companies can expand opportunities to reach patients interested in or needed for specific studies. These organizations can start conversations and dialogue within their communities, particularly those that have historically lacked knowledge about available clinical trials and/or have faced barriers to participation, to help drive diverse enrollment. In the December 2002 GAO report, the organization looked at common practices at centers showing positive diversity results.
Fifteen of the 17 cancer centers had facilitated enrollment with practices in at least three out of four key areas: organization, community, workforce and patients. The community category included ambassador programs and work with community advisors. In the report, The Yale Center for Clinical Investigation cited the success of their 2010-initiated ambassador program, reporting, “the proportion of patients in trials from a racial and ethnic group other than non-Hispanic White increased from 3 percent in 2010 to 32 percent in 2021.” In another example, a guidance document from MRCT outlined community engagement’s role in enhancing trial diversity, highlighting expected outcomes, strategy, and successful case studies. The case examples support the authors’ determination that community engagement aids in enhancing trust, awareness, and knowledge of trials within underrepresented populations.
Another important component is representation and education among sites. Recent research has found a correlation between the diversity of site personnel and diversity of enrolled patients and determined we have an opportunity to address diversity in trials by recruiting investigators reflective of their communities served. It is also critical to provide education for sites to understand the latest guidance from the FDA, as this will empower clinical research associates and the investigators to be knowledgeable of what to look for at the site level, giving every patient the opportunity to participate without encountering biases or barriers. Additionally, patients’ trust in pharma and clinical trials will be boosted by companies that visibly prioritize diversity in their own workforce and advertisements. A more diverse group of decision-makers will help foster diversified thinking for companies to overcome challenges in achieving equitable healthcare.
To truly reach patients, we must recognize the importance of empathy. Patient-centricity is no longer jargon used by the industry; it has now become the orientation of organizations and a part of the process each healthcare stakeholder is taking part in. Patients want to know and understand clinical trials, they want to feel confident and equipped to communicate, and most importantly, they want to know they are safe. Equity in research requires empathy for all patients, so we must seek to understand them first.
Going Beyond the Minimum and Striving for Equitable Health Long-Term
There is a long road ahead to not only tackle clinical trial recruitment issues but also retention and equitable research in healthcare. We will not create meaningful change if we view the FDA’s diversity action plan requirement as simply checking off a box and stopping there. We must think bigger picture, such as encouraging more diverse industry representation from the top down and working more intimately with communities to gain patient trust.
Having brand awareness from B2C companies who are just entering the clinical space like CVS and Walgreens could also generate some of the industry momentum that we need on this issue.
As an industry, we have one common goal which is to improve patient outcomes. Competition should not stand in the way of this goal, and we must foster collaboration among industry stakeholders – pharmaceutical companies, CROs, clinical technology providers, etc. – to create long-term change. This will ultimately enable everyone to build and contribute to bettering industry imperatives in achieving diverse, equitable, and inclusive healthcare for all.
About Kartina Rice
Katrina Rice is the Chief Delivery Officer at Biometrics Services at eClinical Solutions. With a solid history of leading business transformations and managing global portfolios, she is as much at home scaling operations as she is in developing strategies that drive revenue growth. At eClinical Solutions, Katrina was recently promoted from Executive Vice President of Professional Services to Chief Delivery Officer. She has previously held various technical roles at Lockheed Martin Energy Group and Bayer.
References
- Collection of Race and Ethnicity Data in Clinical Trials. Available at: https://www.fda.gov/media/75453/download. Accessed April 2023.
- Federal Actions and Selected Non-Federal Practices to Facilitate Diversity of Patients. Available at: https://www.gao.gov/assets/gao-23-105245.pdf. Accessed April 2023.
- Consolidated Appropriations Act, 2023. Available at: https://www.congress.gov/bill/117th-congress/house-bill/2617. Accessed April 2023.
- Rising Protocol Design Complexity Is Driving Rapid Growth in Clinical Trial Data Volume. Available at: https://www.globenewswire.com/news-release/2021/01/12/2157143/0/en/Rising-Protocol-Design-Complexity-Is-Driving-Rapid-Growth-in-Clinical-Trial-Data-Volume-According-to-Tufts-Center-for-the-Study-of-Drug-Development.html. Accessed April 2023.
- Achieving Diversity, Inclusion, and Equity in Clinical Research. Available at: https://mrctcenter.org/diversity-in-clinical-research/wp-content/uploads/sites/11/2021/09/MRCT-Center-Diversity-Guidance-Document-Version-1.2.pdf. Accessed April 2023.
- Getz, Kenneth, et al. Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity. Therapeutic Innovation & Regulatory Science. 2022; 56, 777-784. doi.org/10.1007/s43441-022-00418-9.