Surrogate endpoints in trials—a call for better reporting

A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials

“…Evidence for the benefits and harms of interventions should come from high-quality RCTs that directly assess treatment effects on a target outcome of interest to patients, clinicians, and other stakeholders, such as all-cause mortality. 37 Evaluating effects on such target outcomes can require trials with large sample sizes, long follow-up times, and high costs. While accepting treatment effects on a biomarker as a replacement for a target outcome has become increasingly commonplace in the regulatory setting, 7 , 8 , 9 there has been much less consideration for the use and implications of intermediate outcomes as surrogate endpoints in the wider context of healthcare interventional trials.…”

A Framework for the Definition and Interpretation of the Use of Surrogate Endpoints in Interventional Trials’

“…Evidence for the benefits and harms of interventions should come from high-quality RCTs that directly assess treatment effects on a target outcome of interest to patients, clinicians, and other stakeholders, such as allcause mortality. 37 Evaluating effects on such target outcomes can require trials with large sample sizes, long follow-up times, and high costs. While accepting treatment effects on a biomarker as a replacement for a target outcome has become increasingly commonplace in the regulatory setting, [7][8][9] there has been much less consideration for the use and implications of intermediate outcomes as surrogate endpoints in the wider context of healthcare interventional trials.…”

Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration

“…Phase 4 is an ongoing knowledge translation that includes dissemination and implementation of extensions. Dissemination efforts have included publication of short articles to publicise the project 32 33 34 35 36 ; publication of protocols 30 31 ; and presentations in meetings and conferences. The completed checklist was piloted by eight trial investigators who had conducted at least one trial by providing them with published trial and asking them to note whether extension items were reported.…”