Despite the regulatory uncertainty surrounding diversity in clinical trials, pharma companies remain committed to the goal of bringing more diverse patient populations into research and development. The industry recognizes that having a more representative population in trials is not only good science but also good ethics and good business.
However, the changing regulatory landscape presents challenges for pharma companies as they navigate the complexities of implementing diversity plans. The absence of clear benchmarks for diversity targets and the lack of specific numeric targets in regulatory guidelines from the FDA create uncertainty for sponsors trying to interpret what constitutes adequate diversity based on various factors.
Additionally, the industry’s technology innovations, such as decentralized clinical trials, raise questions about how companies can blend inclusivity goals with data collection capabilities. While decentralized clinical trials are promoted as a solution for recruitment, the FDA’s expectations regarding data integrity, patient monitoring, and privacy in these trials remain unclear.
Despite these challenges, pharma companies are advised to “stay the course” with their diversity plans and strategies while the FDA’s new leadership settles in. Companies can continue to proactively submit diversity plans and maintain their strategies to ensure that the science does not stop.
While the FDA’s draft guidance on clinical trial diversity provides a roadmap for crafting inclusion plans, its fate remains uncertain following the agency’s rejection of the guidance. As pharma companies navigate the regulatory uncertainties and challenges, it is crucial for them to balance the need for flexibility with the risk of additional review or delays in submissions.
Ultimately, the commitment to diversity and inclusion in clinical trials remains strong within the pharma industry, despite the regulatory complexities and uncertainties. Companies must continue to prioritize diversity in their research and development efforts to improve health outcomes and drive innovation in the field.
The FDA’s proposed guidance on promoting clinical trial diversity may be at risk of being scrapped, leaving companies without clear instructions on how to meet requirements mandated by the DEPICT Act. This act, passed in 2022, aims to increase diversity in clinical trials and represents a step towards stronger enforcement. However, the effectiveness of this mandate will depend on how rigorously the FDA monitors compliance and addresses non-adherence.
In the absence of clear guidance from the FDA, it is crucial for companies to prioritize inclusivity in their clinical trials. One way to do this is by solidifying recruitment strategies, such as forging stronger ties with community organizations to boost trust and access, and leveraging digital tools and tailored outreach plans to reach different patient populations. Creating monitoring and reporting metrics to measure recruitment success and publishing this data can drive accountability and continuous improvement.
Pharmaceutical companies should also invest in training for cultural competencies, design patient-centric trials, and make diversity a core value in their company ethos. When conducting global trials, sponsors can take guidance from other regulators, such as the U.K.’s Health Research Authority and Medicines and Healthcare Products Regulatory Agency, which have published draft guidance and are piloting a program for submitting inclusion plans.
Engaging with the FDA can also help shape future diversity rules and regulations. At a recent conference, company leaders expressed their commitment to diversity goals, even in the absence of clear guidance from the FDA. While it may take some time for the dust to settle from changes at the FDA, companies are determined to continue their efforts towards promoting diversity in clinical trials.
In conclusion, the industry remains committed to diversity goals, with or without FDA guidance. There is still much work to be done, but the dedication to inclusivity and diversity in clinical trials is unwavering. By prioritizing recruitment strategies, training, and accountability, companies can continue to make progress towards more diverse and representative clinical trials.
