Work

Subjective endpoints in clinical trials: the case for blinded independent central review

Year: 2013

Type: article

Abstract: : Primary efficacy and safety endpoints in clinical trials are often subjective assessments made by site personnel. For international confirmatory trials conducted over broad geographic regions and different clinical practice settings, variability in these subjective assessments can be substantial. Centralized endpoint assessment committees (EACs) offer a mechanism through which to reduce assessment bias and potentially increase assessment precision and accuracy, particularly in open-label trials. An overview of regulatory agencies' rationales for an EAC is reviewed. In addition, the two main types of EACs, the blinded independent central review, and the consensus panel are compared. Selection of endpoints for EAC evaluation and design of EAC process to maximize EAC value proposition are also discussed. Keywords: endpoint assessment committee, FDA, central review, BICR, adjudication, consensus panel

Source: Open Access Journal of Clinical Trials

DOI: 10.2147/oajct.s50283

Authors: Richard C Walovitch, Bin Yao, Patrick Chokron, Helen Le, Bubley

Institutions: Amgen (United States), Beth Israel Deaconess Medical Center

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $1,806