The U.S. Food and Drug Administration (FDA) recently issued new guidance on the diversity of clinical trials, encouraging sponsors to include more diverse populations in their studies to better reflect the patient populations for which the drugs are intended. The guidance, which was released in November 2020, builds on previous efforts by the FDA to improve diversity in clinical trials.
Diversity in clinical trials is important because it ensures that the drugs being tested are safe and effective for all patient populations, not just a select few. Historically, clinical trials have been dominated by white male participants, leading to drugs that may not work as well for women and people of color. The FDA’s new guidance aims to address this issue and improve the overall quality of clinical trials.
So, what does this mean for pharmaceutical and biotech companies conducting clinical trials in the United States? It means they need to be more intentional about including diverse populations in their studies. This can be a challenge, as recruiting diverse participants can be difficult, and there are often cultural and language barriers that need to be overcome.
To overcome these new requirements, sponsors will need to work closely with clinical trial sites and patient advocacy groups to develop culturally sensitive recruitment materials and outreach strategies. They may also need to invest in patient education and engagement programs to build trust and awareness among diverse patient populations. For oncology studies, it places a greater burden on selecting the right sites with access to a diverse patient population or selecting a mix of sites in various metros with the right population mix.
Including more diverse patient populations in oncology clinical trials can have significant benefits beyond regulatory compliance. Studies have shown that patients from diverse populations may respond differently to certain cancer treatments and including these patients in clinical trials can lead to better outcomes for all patients.
Overall, the FDA’s new guidance on diversity in clinical trials is an important step forward for improving the quality and relevance of clinical trials. While recruiting diverse patient populations may present challenges, sponsors that invest in effective patient engagement and outreach strategies can reap significant benefits for their clinical trials and ultimately, for patients.
That’s where a specialty oncology CRO like Medelis can help. Medelis has extensive experience in conducting clinical trials in oncology and understands the unique challenges associated with recruiting diverse populations for clinical trials. The company has a team of experts in diversity recruitment who can help sponsors develop strategies to reach out to diverse communities and engage them in clinical trials.
Medelis also has a deep understanding of the regulatory landscape and can help sponsors navigate the FDA’s new guidance on diversity in clinical trials and can provide guidance on best practices for recruiting diverse populations, including developing culturally sensitive materials and engaging with community organizations to build trust and awareness.
Contact us if you’d like to learn more. In addition to patient recruitment, Medelis delivers