Woojung Lee, PharmD
Investing in Clinical Trials for Older Adults: The Value and Challenges of Older Adult-Specific Clinical Trials
Understanding predictors of the low accrual in older adult-specific clinical trials and demonstrating the value of such trials, when successful, can help overcome the underrepresentation of older adults in trials. Aim 1 of this study is to identify trial-level predictors for low accrual in older adult-specific trials. Using AACT data, I will develop prediction models for low accrual based on traditional and machine-learning approaches. Aim 2 of the study is to quantify the realized value of older adult-specific trials, the AVEX and CALGB9343 study. A retrospective analysis of Surveillance, Epidemiology, and End Results (SEER)-Medicare data will be used to estimate the change in practice after the trial publications. State transition models will be developed to estimate the long-term outcomes of treatment studied in the trials. The realized value will be calculated based on these two estimates. By assessing the feasibility and estimating the potential value of older adult-specific trials, this study will facilitate investment and design decisions by funders.
The predoctoral fellowship from the PhRMA Foundation gave me both financial support as well as emotional support. The Foundation’s generous assistance helped alleviate concern about locating funding sources and made it possible for me to focus on the research questions that I am tackling.