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An R-Based Landscape Validation of a Competing Risk Model
Published on: September 16, 2022
Endpoint selection and relative (versus absolute) risk reporting in published medication trials
Michael Hochman1, Danny McCormick
1The Robert Wood Johnson Clinical Scholars® Program, University of California, Los Angeles, USA. Meh1979@gmail.com
Journal of General Internal Medicine
|August 16, 2011
Summary
Misleading clinical trial results are common due to surrogate endpoints and relative risk reporting. Researchers should use absolute terms and highlight endpoint limitations for clearer interpretation.
Area of Science:
- Clinical Trials Methodology
- Biostatistics
- Medical Research Evaluation
Background:
- Surrogate and composite endpoints can obscure clinical trial results.
- Disease-specific mortality and relative risk reporting may also lead to misinterpretation.
- These reporting practices can make trial outcomes difficult to understand.
Purpose of the Study:
- To determine the frequency of surrogate/composite endpoints in medication trials.
- To assess the prevalence of disease-specific mortality as an endpoint.
- To evaluate the use of relative risk reporting in trial abstracts.
Main Methods:
- Analysis of randomized medication trials from top general medicine journals (June 2008-September 2010).
- Quantification of trials using surrogate, composite, or disease-specific mortality endpoints.
- Assessment of abstracts for exclusive relative risk reporting.
Main Results:
- 37% of trials used surrogate endpoints, 34% used composite endpoints.
- 27% of mortality-related endpoints were disease-specific.
- 44% of positive results were reported exclusively in relative terms.
- Surrogate and disease-specific mortality endpoints were more common in commercially funded trials.
Conclusions:
- The use of surrogate/composite endpoints and relative risk reporting is prevalent.
- Disease-specific mortality is a common, potentially misleading, endpoint.
- Clinical trial reporting should emphasize absolute risk and endpoint limitations.
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