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Integrating value of research into NCI Clinical Trials Cooperative Group research review and prioritization: A pilot study.

ABSTRACT: BACKGROUND:The 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. METHODS:We 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. RESULTS:Value 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. 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.

SUBMITTER: Carlson JJ

PROVIDER: S-EPMC6144145 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Integrating value of research into NCI Clinical Trials Cooperative Group research review and prioritization: A pilot study.

Carlson Josh J JJ Kim David D DD Guzauskas Gregory F GF Bennette Caroline S CS Veenstra David L DL Basu Anirban A Hendrix Nathaniel N Hershman Dawn L DL Baker Laurence L Ramsey Scott D SD

Cancer medicine 20180720 9

<h4>Background</h4>The 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.<h4>Methods</h4>We used a previously developed minimal modeling approach to cal ...[more]

PMID: 30030904

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Project description:IntroductionAdaptive designs allow changes to an ongoing trial based on prespecified early examinations of accrued data. Opportunities are potentially being missed to incorporate health economic considerations into the design of these studies.MethodsWe describe how to estimate the expected value of sample information for group sequential design adaptive trials. We operationalize this approach in a hypothetical case study using data from a pilot trial. We report the expected value of sample information and expected net benefit of sampling results for 5 design options for the future full-scale trial including the fixed-sample-size design and the group sequential design using either the Pocock stopping rule or the O'Brien-Fleming stopping rule with 2 or 5 analyses. We considered 2 scenarios relating to 1) using the cost-effectiveness model with a traditional approach to the health economic analysis and 2) adjusting the cost-effectiveness analysis to incorporate the bias-adjusted maximum likelihood estimates of trial outcomes to account for the bias that can be generated in adaptive trials.ResultsThe case study demonstrated that the methods developed could be successfully applied in practice. The results showed that the O'Brien-Fleming stopping rule with 2 analyses was the most efficient design with the highest expected net benefit of sampling in the case study.ConclusionsCost-effectiveness considerations are unavoidable in budget-constrained, publicly funded health care systems, and adaptive designs can provide an alternative to costly fixed-sample-size designs. We recommend that when planning a clinical trial, expected value of sample information methods be used to compare possible adaptive and nonadaptive trial designs, with appropriate adjustment, to help justify the choice of design characteristics and ensure the cost-effective use of research funding.HighlightsOpportunities are potentially being missed to incorporate health economic considerations into the design of adaptive clinical trials.Existing expected value of sample information analysis methods can be extended to compare possible group sequential and nonadaptive trial designs when planning a clinical trial.We recommend that adjusted analyses be presented to control for the potential impact of the adaptive designs and to maintain the accuracy of the calculations.This approach can help to justify the choice of design characteristics and ensure the cost-effective use of limited research funding.

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Integrating value of research into NCI Clinical Trials Cooperative Group research review and prioritization: A pilot study.

Publications

Integrating value of research into NCI Clinical Trials Cooperative Group research review and prioritization: A pilot study.

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