Advanced Clinical Research and Clinical Trials

Biography

Biography: Madhura Joshi

Abstract

For every clinical trial- clear hypothesis, endpoints and study design should be adequate so that study can be easily get regulatory approval. The rate of late stage clinical trial failures is the single biggest determinant of returns on pharmaceutical R&D. If those trials fail (whether for safety or lack of efficacy), all the capital invested up to that point is lost. Thus, understanding of the study endpoints is very important for study success. Study endpoints can vary as per the molecule for which the study is planned and also the therapeutic indication for which it is to be used. Clinical endpoint generally refers to occurrence of a disease, symptom, sign or abnormal laboratory finding that account for one of the target outcomes of the clinical trial. The clinical trial may have one or more clinical endpoints. Endpoints are defined as a measure that allows us to decide whether the null hypothesis of Clinical trial should be accepted or rejected. A clinical trial may have one or more (secondary) endpoints. The primary endpoint of a clinical trial is the endpoint for which subjects are randomized and are essential to establish effectiveness for approval. Secondary endpoints may be used to support the primary endpoints and for which the trial may not be powered nor randomized. As recognized there are three types of Endpoints which is direct, surrogate and composite endpoints. Direct endpoint measure how a patient feels, functions or survives. A surrogate endpoint 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. In composite endpoint, different outcomes are combined into one group. The purpose of this paper is to understand various end points used for different therapeutic indications for particular phase of trial