Surrogate endpoints in clinical trials definition and operational criteria pdf
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- Surrogate Endpoints in Cancer Clinical Trials
- Surrogate endpoint
- Surrogate endpoints in clinical trials: definition and operational criteria.
Felipe A. With the recent progress in imaging technologies for assessment of structural damage in glaucoma, a debate has emerged on whether these measurements can be used as valid surrogate endpoints in clinical trials evaluating new therapies for the disease.
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Surrogate Endpoints in Cancer Clinical Trials
Not a MyNAP member yet? Register for a free account to start saving and receiving special member only perks. Many medical or lifestyle interventions, indispensible to modern medical care, can induce changes in biomarkers. In order for consumers, physicians, drug developers, and policy makers to make informed decisions based on biomarkers, it is important to understand the amount, strength, and quality of data supporting the use of any specific biomarker to direct decisions in clinical care, drug development, public health, and health policy decisions. Even this fairly simple example of a biomarker highlights some of the issues associated with their use. For example, the method used to measure body temperature matters. Using a thermometer is a more accurate approach than a hand to the forehead.
A common problem of interest within a randomized clinical trial is the evaluation of an inexpensive response endpoint as a valid surrogate endpoint for a clinical endpoint, where a chief purpose of a valid surrogate is to provide a way to make correct inferences on clinical treatment effects in future studies without needing to collect the clinical endpoint data. We discuss CEP-based criteria for a useful surrogate endpoint, including 1 the meaning and relative importance of proposed criteria including average causal necessity ACN , average causal sufficiency ACS , and large clinical effect modification; 2 the relationship between these criteria and the Prentice definition of a valid surrogate endpoint; and 3 the relationship between these criteria and the consistency criterion i. This includes the result that ACN plus a strong version of ACS generally do not imply the Prentice definition nor the consistency criterion, but they do have these implications in special cases. Moreover, the converse does not hold except in a special case with a binary candidate surrogate. The results highlight that assumptions about the treatment effect on the clinical endpoint before the candidate surrogate is measured are influential for the ability to draw conclusions about the Prentice definition or consistency. In addition, we emphasize that in some scenarios that occur commonly in practice, the principal strata subpopulations for inference are identifiable from the observable data, in which cases the principal stratification framework has relatively high utility for the purpose of effect modification analysis and is closely connected to the treatment marker selection problem.
Cancer is a major public health problem in the United States and worldwide. In the U. The current estimated lifetime risk of developing an invasive cancer is one in three for woman and an amazing one in two for men. All cancers also share the potential to cause significant morbidity and death. However, the natural history, epidemiology, biology, prevention, detection, and treatment of cancer varies widely by the specific type of cancer. Among other things, these differences necessitate different approaches for each type of cancer in the design and analysis of cancer clinical trials.
November , Volume Number 11 , page 1 - 2 [Free]. Join NursingCenter to get uninterrupted access to this Article. The critical importance of a systematic review protocol for the conduct of the systematic review has been highlighted previously in this journal. It is fundamental that reviewers understand the differences between "surrogate" outcomes and those that are not, and select and justify the outcomes proposed for their review based on sound understanding of their review topic and reasoning. The purpose of this editorial is to touch upon some of these issues by defining "surrogate" outcomes, providing examples, and reflecting on the importance of these types of outcomes for the conduct of systematic reviews.
Surrogate endpoints in clinical trials: definition and operational criteria.
Skip to search form Skip to main content You are currently offline. Some features of the site may not work correctly. DOI: Prentice Published Medicine Statistics in medicine. I discuss the idea of using surrogate endpoints in the context of clinical trials to compare two or more treatments or interventions in respect to some 'true' endpoint, typically a disease occurrence.
In clinical trials , a surrogate endpoint or surrogate marker is a measure of effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship. The National Institutes of Health USA defines surrogate endpoint as "a biomarker intended to substitute for a clinical endpoint". Surrogate markers are used when the primary endpoint is undesired e. The FDA and other regulatory agencies will often accept evidence from clinical trials that show a direct clinical benefit to surrogate markers.
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