Clinical Trial Diversity in Oncology: FDA Takes Action with Post–Marketing Requirements or Commitments

Abstract

Abstract In recent years, there has been a renewed focus on promoting the inclusion of patients from racial and ethnic minority groups in oncology clinical trials. FDA Oncology has long pointed to the underrepresentation of racial minorities in registration trials leading to approval. US FDA’s Guidance on diversity discusses how diversity could be handled within clinical trials, giving recommendations on broadening eligibility criteria, inclusive trial practices, and alternative trial designs. While there is no specific guidance from the FDA on cancer clinical trials, the recommendation is to include a representative population applicable to the US population. With the recent renewed focus on diversity in oncology clinical trials, FDA Oncology has recently asked for the completion of a Diversity Plan during drug development and has issued post–marketing commitments and requirements at the time of approval. As FDA has started to issue post–marketing requirements or commitments regarding diversity in 2020, we sought to analyze the post–marketing studies asking for a study of racial and ethnic minorities issued by the FDA’s Office of Oncologic Diseases (OOD). The analysis demonstrated the need to increase the enrollment of a diverse patient population in cancer clinical trials.