In this article, I will highlight the implications of this mandate on clinical trials. And delve into strategies that can help increase diversity. I will also explore the role of cutting-edge technologies like eCOA/ePRO, patient engagement, and televisits in making clinical trials more inclusive.
FDORA: A Deeper Dive
FDORA, or the Food and Drug Administration’s Diverse Outcomes Research Advancement initiative, is a transformative mandate aimed at promoting diversity and inclusion in clinical trials. Historically, certain populations have been underrepresented, limiting the generalizability of trial results. Accordingly, the FDA recognized the need for better representation of various demographics in clinical research. Historically, certain populations have been underrepresented, limiting the generalizability of trial results.
For sponsors and CROs, FDORA means:
Revising recruitment strategies
Sponsors and CROs must develop recruitment plans that specifically target underrepresented populations. This may involve using targeted advertising, partnering with community organizations, or hosting educational events that cater to diverse groups.
Enhancing training and education
Ensuring that study teams and investigators are trained in cultural competence and sensitivity will be crucial to engaging diverse populations effectively. This training will help study teams understand the unique challenges and barriers faced by underrepresented groups in detail. And in short, develop strategies to address them.
Monitoring diversity metrics
For that reason, to ensure compliance with FDORA, sponsors and CROs must track and report on the diversity of their trial participants. This data will be essential in evaluating the effectiveness of diversity-focused recruitment strategies and identifying areas for improvement.
Adapting study designs
Sponsors and CROs may need to modify their study designs to accommodate the needs of diverse populations. For instance, this could involve incorporating endpoints that are more relevant to specific populations, adjusting dosing regimens, or considering potential drug interactions due to genetic variations.
Addressing logistical barriers
Obviously, FDORA requires sponsors and CROs to consider the logistical challenges that may prevent diverse populations from participating in clinical trials. This could include providing transportation assistance, offering flexible scheduling options, or minimizing the number of required clinic visits.
Engaging with regulators
As FDORA is an FDA mandate, thus, sponsors and CROs will need to engage with regulatory authorities to ensure compliance. This may involve seeking guidance on study designs, submitting diversity-related data, or participating in FDA workshops focused on diversity and inclusion in clinical trials.
In summary, the FDA’s FDORA initiative represents a significant shift in the clinical trial landscape. Sponsors and CROs will need to adapt their strategies and operations to prioritize diversity and inclusion in their studies. To be sure, these efforts will ultimately lead to more representative clinical trials and improved patient outcomes. And furthermore, a better understanding of the safety and efficacy of treatments across various populations.
FDORA’s Impact on Clinical Trials: The Bigger Picture
FDORA is a game-changer for clinical trials. This new mandate aims to ensure that clinical trials become more representative of the real-world population, allowing for better generalization of results.
Sponsors, CROs, and vendors will need to reevaluate their recruitment and retention strategies, implement new processes, and consider adopting innovative technologies to meet FDORA’s objectives. This shift will lead to improved patient outcomes and a more robust understanding of treatments across different populations.
Strategies to Increase Diversity in Clinical Trials
Broadening eligibility criteria
By expanding eligibility criteria, sponsors and CROs can include a more diverse patient population. This will require careful consideration of factors like age, ethnicity, and comorbidities to ensure that trials are both safe and representative.
Building partnerships with community organizations and healthcare providers can help reach diverse populations. By fostering trust and providing culturally sensitive information, sponsors and CROs can encourage participation from underrepresented groups.
Reducing language barriers
Offering study materials in multiple languages and providing translators can help overcome language barriers and increase accessibility for a wider range of participants.
Leveraging Technology to Improve Diversity
eCOA/ePRO: Electronic Clinical Outcome Assessments (eCOA) and Electronic Patient-Reported Outcomes (ePRO) can streamline data collection and make it easier for diverse populations to participate in clinical trials. By allowing patients to report their outcomes electronically, it reduces the burden on participants and improves data accuracy.
Patient engagement platforms: These digital tools can help bridge the communication gap between patients, healthcare providers, and study teams. They can facilitate better information exchange, allowing sponsors and CROs to provide personalized support and resources to diverse patient populations.
Televisits: Telemedicine has revolutionized healthcare, and its use in clinical trials is no exception. Televisits can improve accessibility for patients in remote or underserved areas, removing geographical barriers to participation and increasing diversity.
How Can We Work Together to Make Trials More Inclusive?
The FDA’s FDORA mandate is a significant step towards ensuring that clinical trials are more inclusive and representative. By adopting strategic approaches and embracing innovative technologies, sponsors, CROs, and vendors can make clinical trials more diverse, ultimately leading to better patient outcomes and a deeper understanding of treatments across various populations.
At Datacubed Health, we live our diversity message. Our mission is to advance access to healthcare for everyone, everywhere, and this mandate is a giant step forward. We recognized the need for a digitally inclusive space where all patients could feel like partners, not “research subjects.” From protocol review to translations to inclusive solutions like eCOA/ePRO, patient engagement, and TeleVisits, diversity and inclusion are at the core. Don’t take my word for it, schedule a demo today to discover the Datacubed difference.