A perspective on surrogate endpoints in controlled clinical trials

The last couple of decades have seen a large amount of activity in the area of surrogate marker and surrogate endpoint validation, both from a clinical and ...

A framework for the definition and interpretation of ... - PubMed Central

The focus of surrogate endpoint use in trials has traditionally been directed by regulatory bodies such as the US Food and Drug administration (FDA) and ...

Surrogate Endpoints in Clinical Trials | Annual Reviews

Surrogate markers are often used in clinical trials settings when obtaining a final outcome to evaluate the effectiveness of a treatment ...

What clinicians should know about surrogate end points in ...

Use of surrogates as primary end points is commonplace in hematology/oncology clinical trials. As opposed to prognostic markers, surrogates are end points ...

Frequently asked questions on surrogate endpoints in oncology ...

Many surrogate endpoints have been used in oncology clinical trials and they can be classified in several ways- for example, surrogate endpoints ...

Surrogate Endpoint Resources for Drug and Biologic Development

Surrogate endpoints may be used instead of clinical outcomes in some clinical trials. ... surrogate endpoint, such as controlling blood ...

Reporting of surrogate endpoints in randomised controlled trial ...

Depending on the disease or health area and definitions of a surrogate endpoint, between 17% and 78% of trials use surrogate endpoints as ...

Surrogate endpoints: a key concept in clinical epidemiology

If a surrogate endpoint satisfies all these criteria, it may be considered a valid and useful substitute in clinical trials. If, on the other ...

Binary surrogate endpoints in clinical trials from the perspective of ...

Abstract Introduction Surrogate endpoints are widely used in clinical trials, especially in situations where the endpoint of interest is not ...

Time to Review the Role of Surrogate End Points in Health Policy

The use of surrogate end points in clinical trials means that policymakers must extrapolate from these findings to estimate the true benefits to patients and ...

Surrogate Endpoints, Biomarkers, and More - Day 2 - YouTube

As the biological mechanisms of diseases and pharmacological activities of therapeutics are better understood, this information provides ...

Endpoint surrogacy in oncology Phase 3 randomised controlled trials

Endpoint surrogacy is an important concept in oncology trials. Using a surrogate endpoint like progression-free survival as the primary endpoint ...

Surrogate endpoints in oncology: when are they acceptable for ...

surrogates as an endpoint in clinical trials and basis for regulatory ... endpoint of oncology randomized controlled trials (RCTs).

Surrogate endpoints: a key concept in clinical epidemiology

... controlled trials; Clinical epidemiology; Indirectness; Outcome measures; Endpoints ... Contemporary research emphasizes the perspective and.

Reporting of surrogate endpoints in randomised controlled trial ...

But reliance on surrogate endpoints can increase the uncertainty of an intervention's treatment effect and potential failure to provide adequate ...

Surrogate endpoints: a key concept in clinical epidemiology

Surrogate endpoints are biomarkers or intermediate outcomes that are used as substitutes for clinical outcomes of interest, often to expedite research or ...

Surrogate Endpoints.pdf - EUnetHTA

The validation of a surrogate endpoint requires extensive research, including randomized controlled trials. (RCT) assessing clinical relevant endpoints. The ...

Frequently asked questions on surrogate endpoints in oncology ...

Analysis of the adequacy of control arms in oncology randomized clinical trials published be- tween 2017 and 2021: a meta-research study. Eur J Cancer. 2023 ...

Surrogate endpoints: A basis for a rational approach

In clinical trials, the clinical endpoint is often replaced by an intermediate endpoint, known in some instances as a “surrogate” endpoint.

Surrogate endpoints: when to use and when not to use? A critical ...

The use of unplanned surrogate outcomes that arise during the study requires a lot of caution. Dentistry; Clinical Trials; Ethics; Biomarkers. Introduction. The ...