Underrepresentation of older Indian persons with cancer in clinical trials

Purpose : Older patients with cancer have traditionally been underrepresented in global clinical trials. There are no data from India regarding this issue. Material and methods : A retrospective analysis done at our institute on interventional studies conducted between 2003 and 2023 in adult patients with malignancies. We excluded studies done exclusively in pediatric population, and observational studies. Results : We included 21,894 patients enrolled in 150 interventional trials from the Departments of Surgical, Medical, and Radiation Oncology, Anesthesia, and Clinical Pharmacology; 110 (73.3%) were investigator-initiated. There were 38 trials (25.3%) in breast cancer (6141 patients, 28%), and 33 (22%) in head-and-neck cancer (6975 patients, 31.9%). Studies were predominantly Phase III (97 trials [64.7%]). Multicentric studies comprised approximately a third (48, 32%). The median age of enrolled patients was 51 years (IQR, 43-59). There were 5132 (23.4%) participants aged > 60 years, 2678 (12.2%) > 65 years, and 1045 (4.8%) > 70 years. Data from the hospital registry revealed that 30% of adult registrations were > 60 years. There was a significant increase in the proportion of older patients enrolled in clinical trials from 2003 (8%) to 2019 (22%) compared to their proportion in the hospital registry (stable at 28-29%); P<0.001. Conclusion : Older Indian adults with cancer are underrepresented in interventional clinical trials, however this has improved over time. Various factors that limit recruitment of this vulnerable cohort like age-specific eligibility criteria are immediately actionable to make clinical trials more inclusive.