How Relevant Are Clinical Trials to Clinical Practice?

Not very, at least when it comes to patient-important outcomes in diabetes, according to an analysis of endpoints listed in three trial registries

Recent controversy has surrounded the interpretation of surrogate endpoints (findings that are associated with favorable or unfavorable outcomes, used instead of the outcomes themselves) in clinical trials. In this study, investigators sought to determine how often outcomes deemed important to patients (cardiovascular events, death, pain, function, and quality of life) — versus surrogates — are prespecified outcomes of clinical diabetes research. The same authors have previously reported that only one in five published studies of diabetes interventions assessed patient-centric outcomes.

For this analysis, the investigators reviewed 436 phase II, III, and IV randomized, controlled clinical trials of diabetes interventions (planned, in progres…

Reviewing Author

JoAnne M. Foody, MD

Disclosures

Consultant / Advisory boardAegerion; Amarin; Bristol-Myers Squibb; Janssen; Merck; Pfizer; Sanofi-Aventis; Boehringer Ingelheim

Leadership positions in professional societiesAmerican College of Cardiology, Cardiosmart (Co-chair)

JoAnne M. Foody, MD

Disclosures

Consultant / Advisory boardAegerion; Amarin; Bristol-Myers Squibb; Janssen; Merck; Pfizer; Sanofi-Aventis; Boehringer Ingelheim

Leadership positions in professional societiesAmerican College of Cardiology, Cardiosmart (Co-chair)

How Relevant Are Clinical Trials to Clinical Practice?

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Reviewing Author