With a focus on modernization, the International Council for Harmonisation (ICH) on Thursday released for public consultation a draft version of its guideline E8(R1) on the general considerations for clinical trials.
The 33-page revised guideline, which is part of a broader good clinical practice renovation initiated in 2017, identifies critical-to-quality factors (with select examples) that can be adapted to different types of trials, addresses a broader range of trial designs and data sources and provides an updated cross-referencing of other relevant ICH guidelines related to planning clinical studies.
E8(R1) is broken down by sections on designing quality into clinical trials, drug development planning, design elements for clinical studies, conduct and reporting and considerations in identifying critical-to-quality factors.
ICH lays out four objectives for the document:
- To describe principles and practices related to the design and conduct of clinical studies to ensure data and results are accepted by regulators;
- To provide guidance on considering quality in designing and conducting trials, including identifying factors that are critical to quality in the study planning phase and how to manage certain risks;
- To provide an overview of the types of studies conducted, as well as to describe how to determine which quality factors can ensure study subject protection, integrity of data, the reliability of results and the ability of studies to meet their objectives;
- To provide a guide to the ICH efficacy documents in two annexes.
The guideline also describes in several sections how the patient’s perspective should be included in some of the discussions around how the trials are set up and conducted.
“Involving patients at the early stage of study design is likely to increase trust in the study, facilitate recruitment, and promote adherence, which should continue throughout the duration of the study,” the guideline says.
In terms of the focus on quality, the guideline explains how the proactive communication of the critical-to-quality factors and risk mitigation activities will support a better understanding of the priorities and resource allocation by the sponsor and investigator sites.
“A key aspect of a quality approach to study design is to ask whether the objectives being addressed by the study are clearly articulated; whether the study is designed to meet the need it sets out to address; whether these needs are meaningful to patients; and whether the study hypotheses are specific, timely and scientifically valid,” the guideline adds.
Several of the subsections of the guideline deal with methods to reduce or assess bias, protocol adherence, safety monitoring and the data monitoring committee.