I would like to discuss the FDA’s recent guidance on enhancing diversity in clinical trials. This initiative is a commendable step toward ensuring that drug trials better reflect the populations they aim to serve. It broadens eligibility criteria, adopts inclusive enrollment practices, and seeks to reduce participant burden to make clinical trials more accessible to diverse populations.
While the guidance focuses on drugs and biological products, the principles and recommendations outlined in it are also relevant to medical device studies. I believe these diversity efforts should extend beyond clinical trials to include human factors studies, label and user comprehension, self-selection, and other non-clinical studies.
These efforts should encompass a broader range of research areas, including exploring how different populations interact with and understand medical products. It is essential to ensure that diverse groups are represented in all aspects of clinical research and development.
Why Diversity in Non-Clinical Studies Matters
It is also important to have diverse groups of people participate in non-clinical user research. This includes label comprehension, user comprehension, simulated use, self-selection, and other human factors studies.
These studies help ensure that medical devices and drug labels are user-friendly and understandable across all populations, especially those historically underrepresented in similar research. When we overlook diversity in these areas, we risk creating products that do not meet everyone’s needs, potentially worsening health disparities and perpetuating inequities.
Building on the FDA’s Initiative
The FDA’s advice on diversity in clinical trials can also be helpful for non-clinical studies. Here are three key areas where these principles can make a significant impact:
Inclusive Study Practices in Non-Clinical Research
By adopting inclusive practices similar to those recommended in the FDA’s diversity guidance, we can ensure that non-clinical studies reflect our society’s diverse demographics. This means broadening eligibility criteria and actively recruiting participants from various backgrounds to understand how different groups interact with healthcare products.
Reducing Participant Burden in Human Factors Studies
Simplifying protocols and providing logistical support, such as flexible scheduling and remote participation options, can make it easier for a diverse group of users to participate in non-clinical studies. Offering services like transportation or childcare can further reduce barriers, making these studies more accessible to all. Conducting studies remotely (e.g., via Zoom) or as self-administered data collection can also make participation easier.
Enhanced Recruitment and Retention for Comprehension Studies
Effective recruitment and retention strategies are crucial for achieving diversity in non-clinical studies. Community engagement, culturally tailored communication, and targeted outreach to underrepresented groups can help ensure that we include diverse populations when developing and evaluating medical devices and drug labels. Studies must also allow participants to engage in ways that are easiest for them, including remotely when possible.
A Hopeful Perspective
Social scientists have been conducting diverse and inclusive research for decades. Surveys, commonly used in this kind of work, have long emphasized diversity in age, gender, race/ethnicity, and other factors. Researchers in the social sciences often conduct studies with the goal of representing a larger population, often the U.S. population.
Social sciences have shown that researchers can successfully include diversity in their work with minimal challenges. This proves that high-quality human factors researchers can integrate these practices effectively.
Final Thoughts
The FDA’s recent diversity guidelines are a significant achievement in promoting inclusivity in clinical research. However, extending these efforts to other types of studies, such as human factors and user comprehension studies is crucial. By adopting inclusive study practices, reducing participant burden, and enhancing recruitment and retention, we can ensure that we design and test healthcare products to meet the needs of a diverse population.
Let’s continue to advocate for the broader application of these diversity efforts to improve health outcomes for everyone. I think we can apply social science research to extend these principles beyond clinical trials. This can help in developing a healthcare system that is more inclusive and fair.
Stay tuned for more updates and insights as we continue to explore the future of inclusive healthcare research.