Exploratory analyses of clinical trial data used for health technology assessments: a retrospective evaluation.

ABSTRACT:

Objectives

To examine the validity and statistical limitations of exploratory analyses of clinical trial data commonly requested by agencies responsible for determining which medical products may be financed or reimbursed by a healthcare system.

Design

This was a retrospective review of efficacy and safety analyses conducted for German Health Technology Assessment (HTA) evaluations with a decision date between 2015 and 2020, and an illustrative safety-related exploratory analysis of data from two phase III clinical trials of verubecestat (an anti-amyloid drug whose development was stopped for lack of efficacy) as would be mandated by the German HTA agency.

Results

We identified 422 HTA evaluations of 404 randomised controlled clinical trials. For 140 trials (34.7%), t

SUBMITTER: Oddens BJ 

PROVIDER: S-EPMC9345082 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature