Development and Evaluation of an Approach to Using Value of Information Analyses for Real-Time Prioritization Decisions Within SWOG,a Large Cancer Clinical Trials Cooperative Group

Abstract

Objective. Value of information (VOI) analyses can align research with areas with the greatest potential impact on patient outcome, but questions remain concerning the feasibility and acceptability of these approaches to inform prioritization decisions. Our objective was to develop a process for calculating VOI in “real time” to inform trial funding decisions within SWOG, a large cancer clinical trials group. Methods. We developed an efficient and scalable VOI modeling approach using a selected sample of 9 randomized phase II/III trial proposals from the Breast, Gastrointestinal, and Genitourinary Disease Committees reviewed by SWOG’s leadership between 2008 and 2013. There was bidirectional communication between SWOG investigators and the research team throughout the modeling development. Partial expected value of sample information for the treatment effect evaluated by the proposed trial’s primary endpoint was calculated using Monte Carlo simulation. Results. We derived prior uncertainty in the treatment effect estimate from the sample size calculations. Our process was feasible for 8 of 9 trial proposals and efficient: the time required of 1 researcher was <1 week per proposal. We accommodated stakeholder input primarily by deconstructing VOI metrics into expected health benefits and incremental healthcare costs and assuming treatment decisions within our simulations were based on health benefits. Following customization, feedback from over 200 SWOG members was positive regarding the overall VOI framework, specific retrospective results, and potential for VOI analyses to inform future trial proposal evaluations. Conclusions. We developed an efficient and customized process to calculate the expected VOI of cancer clinical trials that is feasible for use in decision making and acceptable to investigators. Prospective use and evaluation of this approach is currently underway within SWOG.