"Geriatricizing" Drug Development - A Young International Society of Geriatric Oncology Letter to the Editor.

We read Lee and colleagues' systematic review on geriatric assessments (GA) in cancer clinical trials [ [1] Lee W. Cheng S.J. Grant S.J. et al. Use of geriatric assessment in cancer clinical trials: a systematic review. J Geriatr Oncol. 2022; 13: 20220509https://doi.org/10.1016/j.jgo.2022.04.014 Abstract Full Text Full Text PDF Scopus (8) Google Scholar ] with great interest. This study provides a comprehensive review of how the GA has been adopted and adapted for use in existing cancer clinical trials. We wish to discuss gaps and next steps on topics highlighted by Lee et al. using recent solutions proposed during the 2021 National Academies of Sciences, Engineering, and Medicine (NASEM) workshop on improving the evidence base for older adults with cancer which brought together geriatric oncology experts from within and across the clinical research and regulatory strata (see Table 1). Table 1NASEM improving the evidence base for treatment decision making for older adults with cancer virtual workshop 2021 adapted recommendations. ⁎ Adapted from: Moderators Summaries of Issues and Solutions. Improving the Evidence Base for Treatment Decision Making for Older Adults with Cancer: A Virtual Workshop. The National Academies of Sciences, Engineering, and Medicine, 2021. ▪Optimize Eligibility oRequire implementation of modernized eligibility criteria as standard practice oUtilize standardized GA measures to design trials for vulnerable/frail older adults oInclude geriatric oncology experts on therapeutic development and study design teams oConduct separate, adequately powered studies with eligibility limited to older or frail adults (when possible) ▪Patient Preferences as Endpoints oConduct older adult-specific trials with emphasis on treatment tolerance and geriatric-focused endpoints oDevelop and validate new endpoints that better define clinical benefit in older or more frail adults ▪Innovate and Leverage Technology oIncorporate a standardized set of core GA measures (minimum data set) into all treatment trials enrolling older adults oLeverage local trial/practice sites to use web- and app-based tools for symptom assessment oExtend geroscience to the nonclinical investigation of anticancer agent efficacy and toxicity Adapted from: Moderators Summaries of Issues and Solutions. Improving the Evidence Base for Treatment Decision Making for Older Adults with Cancer: A Virtual Workshop. The National Academies of Sciences, Engineering, and Medicine, 2021. Open table in a new tab