Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments.

ABSTRACT:

Importance

Surrogate markers are increasingly used as primary end points in clinical trials supporting drug approvals.

Objective

To systematically summarize the evidence from meta-analyses, systematic reviews and meta-analyses, and pooled analyses (hereafter, meta-analyses) of clinical trials examining the strength of association between treatment effects measured using surrogate markers and clinical outcomes in nononcologic chronic diseases.

Data sources

The Food and Drug Administration (FDA) Adult Surrogate Endpoint Table and MEDLINE from inception to March 19, 2023.

Study selection

Three reviewers selected meta-analyses of clinical trials; meta-analyses of observational studies were excluded.

Data extraction and synthesis

Two reviewers extracted corre

SUBMITTER: Wallach JD 

PROVIDER: S-EPMC11036312 | biostudies-literature | 2024 May

REPOSITORIES: biostudies-literature