Developing generic templates to shape the future for conducting integrated research platform trials.

ABSTRACT:

Background

Interventional clinical studies conducted in the regulated drug research environment are designed using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E6 (R2) Good Clinical Practice-scientific guideline, first published in 2002 and last updated in 2016. This document provides an international ethical and scientific quality standard for designing and conducting trials that involve the participation of human subjects. Recently, there has been heightened awareness of the importance of integrated research platform trials (IRPs) designed to evaluate multiple therapies simultaneously. The use of a single master protocol as a key source document to fulfill trial conduct obligations has resulted in a re-examination of the templates used to fulfi

SUBMITTER: Gidh-Jain M 

PROVIDER: S-EPMC10956223 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature