Abstract

BackgroundThe Institute of Medicine has called for approaches to help maximize the return on investments (ROI) in cancer clinical trials. Value of Research (VOR) is a health economics technique that estimates ROI and can inform research prioritization. Our objective was to evaluate the impact of using VOR analyses on the clinical trial proposal review process within the SWOG cancer clinical trials consortium.MethodsWe used a previously developed minimal modeling approach to calculate VOR estimates for 9 phase II/III SWOG proposals between February 2015 and December 2016. Estimates were presented to executive committee (EC) members (N = 12) who determine which studies are sent to the National Cancer Institute for funding consideration. EC members scored proposals from 1 (best) to 5 based on scientific merit and potential impact before and after receiving VOR estimates. EC members were surveyed to assess research priorities, proposal evaluation process satisfaction, and the VOR process.ResultsValue of Research estimates ranged from −$2.1B to $16.46B per proposal. Following review of VOR results, the EC changed their score for eight of nine proposals. Proposal rankings were different in pre‐ vs postscores (P value: 0.03). Respondents had mixed views of the ultimate utility of VOR for their decisions with most supporting (42%) or neutral (41%) to the idea of adding VOR to the evaluation process.ConclusionsThe findings from this pilot study indicate use of VOR analyses may be a useful adjunct to inform proposal reviews within NCI Cooperative Clinical Trials groups.

Highlights

  • The National Academy of Medicine (formerly the Institute of Medicine has called for approaches to help maximize the return on research investments in cancer clinical trials, stating that, “prioritization and selection of trial concepts is critical to ensure that limited public funds are used in ways that are likely to have the greatest impact on patient care.”[1]. Value of Research (VOR; known as Value of Information, VOI) analysis is a health economics technique that estimates the clinical and economic returns for research investments.[2,3,4,5,6,7]

  • The scores for six of the nine proposals changed in the direction of the comprehensive VOR estimate, one did not change and two moved in the opposite direction

  • As an experiment to aid decision making about clinical trial research prioritization, we developed and implemented a VOR evaluation process for SWOG, a large NCI-­sponsored cancer clinical trials cooperative research group

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Summary

Introduction

The National Academy of Medicine (formerly the Institute of Medicine has called for approaches to help maximize the return on research investments in cancer clinical trials, stating that, “prioritization and selection of trial concepts is critical to ensure that limited public funds are used in ways that are likely to have the greatest impact on patient care.”[1] Value of Research (VOR; known as Value of Information, VOI) analysis is a health economics technique that estimates the clinical and economic returns for research investments.[2,3,4,5,6,7] VOR estimates the value of reducing treatment decision uncertainty, by comparing the evidence that exists for a therapy today vs the aggregated evidence generated by collecting additional information (eg, through a clinical trial). Conclusions: The findings from this pilot study indicate use of VOR analyses may be a useful adjunct to inform proposal reviews within NCI Cooperative Clinical Trials groups

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