Assessing the validity of surrogate endpoints in the context of a controversy about the measurement of effectiveness of hepatitis C virus treatment

Claudia C. Dobler, Rebecca L. Morgan, Yngve Falck-Ytter, Victor M. Montori, M. Hassan Murad

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Surrogate endpoints are often used in clinical trials, as they allow for indirect measures of outcomes (eg, shorter trials with less participants). Improvements in surrogate endpoints (eg, reduction in low density lipoprotein cholesterol, normalisation of glycated haemoglobin) achieved with an intervention are, however, not always associated with improvements in patient-important outcomes. The common tendency in evidence-based medicine is to view results based on surrogate endpoints as less certain than results based on long term, final patient-important outcomes and rate them as ' lower quality evidence'. However, careful appraisal of the validity of a surrogate endpoint as a measure of the final, patient-important outcome is more useful than an automatic judgement. In this guide, we use a contemporary and currently highly debated example of the surrogate endpoint ' sustained viral response' (ie, viral eradication considered to represent successful treatment) in patients treated for chronic hepatitis C virus. We demonstrate how the validity of a surrogate endpoint can be critically appraised to assess the quality of the evidence (ie, the certainty in estimates) and the implications for decision-making.

Original languageEnglish
Pages (from-to)50-53
Number of pages4
JournalEvidence-Based Medicine
Volume23
Issue number2
DOIs
Publication statusPublished - 1 Apr 2018
Externally publishedYes

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Hepacivirus
Biomarkers
Therapeutics
Evidence-Based Medicine
Glycosylated Hemoglobin A
Chronic Hepatitis C
LDL Cholesterol
Decision Making
Outcome Assessment (Health Care)
Clinical Trials

Cite this

Dobler, Claudia C. ; Morgan, Rebecca L. ; Falck-Ytter, Yngve ; Montori, Victor M. ; Murad, M. Hassan. / Assessing the validity of surrogate endpoints in the context of a controversy about the measurement of effectiveness of hepatitis C virus treatment. In: Evidence-Based Medicine. 2018 ; Vol. 23, No. 2. pp. 50-53.
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Assessing the validity of surrogate endpoints in the context of a controversy about the measurement of effectiveness of hepatitis C virus treatment. / Dobler, Claudia C.; Morgan, Rebecca L.; Falck-Ytter, Yngve; Montori, Victor M.; Murad, M. Hassan.

In: Evidence-Based Medicine, Vol. 23, No. 2, 01.04.2018, p. 50-53.

Research output: Contribution to journalArticleResearchpeer-review

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