Applied regulatory science research to understand factors that affect the safety and treatment response of underrepresented subgroups in oncology therapeutic development

OCE is interested to understand factors that affect the safety and treatment response in oncology therapeutic development for demographic subgroups that have been historically underrepresented in oncology trials (e.g., racial/ethnic minorities, sexual and gender minorities, older adults). Risk factors, underlying differences in the disease biology, and access to healthcare may vary in these populations and impact outcomes. FDA seeks to obtain information about these special populations to assess whether evidence generated in clinical trials to support the safety and effectiveness of therapeutics is generalizable to the larger patient population. Topics of particular interest to OCE include: • Conducting root-cause analysis to understand barriers to including underrepresented groups in oncology clinical trials, not previously reported• Identifying best practices for enrolling underrepresented groups in oncology, particularly in trials sponsored by the pharmaceutical industry, including related to site and investigator selection practices• Characterizing the prevalence of druggable biomarkers in racial and ethnic minorities and assess implications for enrollment in clinical trials, including biomarkers still in development• Understanding the impact of remote assessments and decentralized procedures on enrollment of underrepresented demographic groups• Using real world data (RWD) to understand the impact of treating patients with cancer who are members of underrepresented demographic groups with approved drugs who may not have been eligible for clinical trials• Using RWD to understand patterns of care and clinical outcomes in sexual and gender minorities with cancer• Identifying best practices for data collection to characterize experience of persons who are members of sexual and gender minority groups, in cancer clinical trials• Developing frameworks for assessing clinical site readiness to achieve adequate enrollment of underrepresented minorities• Identifying best practices to conduct multi-regional cancer clinical trials in regions of the world not traditionally represented in global cancer trials (e.g., Africa, Central America, South America).
Categories: Consumer Protection, Science and Technology and other Research and Development.