Analyzing and Interpreting Clinician and Patient Adverse Event Data to Better Understand Tolerability in ECOG-ACRIN Studies

The purpose of this project is to further develop methods for better understanding tolerability (the degree to which adverse effects of a cancer treatment drug and other aspects of a drug can be tolerated by a patient) by analyzing clinical trials adverse event data, including patient-reported outcome measures. An additional purpose is to create a consortium of the funded research teams comprised of principal investigators, biostatisticians, data scientists, investigators with patient-reported outcome (PRO) measurement expertise, and cancer clinical trialists to share analytic approaches to determine tolerability and develop a menu of methods for public use. We propose the creative analysis of robust data sets from ECOG-ACRIN clinical trials which contain multiple elements relevant to improving our understanding of patient tolerability. If the project requires, Northwestern will execute a data use agreement with ECOG-ACRIN to obtain de-identified data from selected clinical trials and obtain approval from Northwestern’s IRB to conduct said analyses. Dr. Cella will provide expertise on PRO analysis, including input on innovative ways to graphically present and analyze PRO data. Dr. Cella also brings extensive knowledge of PRO design, having contributed to the design of the ECOG-ACRIN trials selected for analysis. Dr. Estabrook will both carry out analyses and guide analyses carried out at other study sites, specifically related to the evaluation of PRO-CTSAEs with respect to their sensitivity to change, cumulative burden, and prediction of subsequent adverse events. Additionally, Dr. Estabrook will continue improving the modeling and programing tools required to estimate the models described in this proposal.