Can value-of-Information estimates help funding organizations prioritize which cancer studies to fund? / Scott D. Ramsey.

Format:

Book

Author/Creator:

Ramsey, Scott D., author.

Language:

English

Subjects (All):

Biomedical Research.

Tumors.

Clinical trials.

Physical Description:

1 online resource (269 pages) : illustrations

Place of Publication:

Washington, District of Columbia : Patient-Centered Outcomes Research Institute (PCORI), 2018.

Summary:

BACKGROUND: The Institute of Medicine, now the National Academy of Medicine, has called for approaches to help maximize the return on research investments in cancer clinical trials. Value of information (VOI) analysis is a health economics technique that estimates the clinical and economic returns for research investments and can inform research prioritization. OBJECTIVES: Develop a process for calculating VOI for trial proposals from SWOG (formerly the Southwest Oncology Group) and evaluate the impact on the SWOG Executive Committee's (EC's) clinical trial proposal review scores. METHODS: This study setting was SWOG, a large US cancer clinical trials cooperative group that develops and conducts cancer clinical trials. The VOI intervention was aimed at SWOG's Executive Committee. For the first phase, we adapted a novel and efficient modeling approach--minimal modeling VOI--using a random sample of 9 retrospective randomized phase 2/3 trial proposals from the Breast, Gastrointestinal, and Genitourinary Committees, which had previously been reviewed by the EC. Bidirectional communication between SWOG stakeholders and the research team occurred throughout the modeling development. We calculated partial expected value of sample information (EVSI) for the treatment effect evaluated by the proposed trial's primary end point using Monte Carlo simulation. For the second phase, we prospectively developed 9 VOI models between February 2015 and December 2016. We presented results to EC members, who scored each study proposal before and after receiving VOI estimates. Scores ranged from 1 to 5, with 1 being the best. We used the Wilcoxon signed rank test to evaluate the change in prescores versus postscores for each proposal. We developed a survey for the EC after the prospective evaluation to assess committee members' perspectives and experience with the VOI intervention. We evaluated the survey results using descriptive statistics. RESULTS: Our process was feasible for 8 of 9 trial proposals and efficient: The time required was <1 week per proposal. We accommodated stakeholder input by deconstructing VOI metrics into expected health benefits and incremental health care costs and assuming treatment decisions within our simulations were based on health benefits. Feedback from more than 200 SWOG members was positive regarding the VOI framework, specific retrospective results, and potential for VOI analysis to inform future trial proposal evaluations. For the second phase, population-level EVSI estimates for the 9 new proposals ranged from −2.1 billion to 16 billion. EC scores changed after members received VOI estimates for 8 of 9 proposals. Proposal rankings were significantly different in the prescores versus postscores (P = .03). There was no significant association between VOI estimates and the magnitude of the change in proposal scores (P > .05). The survey results indicate that EC members were generally positive or neutral about the VOI process and its use as part of SWOG decision-making. LIMITATIONS: The key limitations for our study were the small number of proposals available to evaluate, the focus of the phase 2 and 3 studies is the comparator arms rather than all SWOG studies, and the changes in the composition of the EC over time. CONCLUSIONS: Presenting VOI estimates influenced EC scores for SWOG trial proposals and was generally viewed favorably by EC members. VOI may add important data to inform reviews of trial proposals within National Cancer Institute Cooperative Clinical Trials group settings.

Notes:

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