Over the past few decades, FDA policy initiatives have focused on promoting enrollment practices that lead to clinical trials better reflecting the population most likely to use the drug. These enrollment practices include enrolling diversity in ages, gender, race, and ethnicity. Diversity within the trial is essential so that data reflect the effectiveness and potential side effects for all groups. However, data has shown that Blacks, Latinos, Asians, and others are significantly underrepresented in clinical research. In June 2019, and per a FDARA mandate, FDA issued guidance for industry providing recommendations to ensure broadening eligibility criteria and avoiding unnecessary exclusions for clinical trials. While creating diversity in clinical trials is vital, it is not without its challenges.
Through presentations and panel discussion, this session will highlight the necessity for diversity in clinical trials and address the clinical, operational, and regulatory challenges that sponsors to ensure diversity is achieved.
Expand understanding of the critical need for diversity in clinical trials
Recognize the clinical, operational, and regulatory challenges in achieving diversity
Develop strategic approaches to overcome these challenges to ensure clinical trials better reflect the populations to use a drug