The International Council for Harmonisation (ICH) have released a draft version of their guideline E8(R1) on the general considerations for clinical trials, which is open for public consultation.
The revised guideline details critical-to-quality factors that may be adapted to different types of trials and addresses a broader range of trial designs and data sources. The guideline provides an updated cross-referencing of other relevant ICH guidelines related to planning clinical studies. The guidance also explains how the patient’s perspective should be included in some of the discussions around how the trials are set up and conducted.
The ICH guidance is intended to do the following:
- “Describe internationally accepted principles and practices in the design and conduct of clinical studies that will facilitate acceptance of data and results by regulatory authorities.
- Provide guidance on the consideration of quality in the design and conduct of clinical studies across the product lifecycle, including the identification during study planning of factors that are critical to the quality of the study, and the management of risks to those factors during study conduct.
- Provide an overview of the types of clinical studies performed during the product lifecycle, and describe the aspects of those studies that support the determination of which quality factors are critical to ensuring the protection of study subjects, the integrity of the data, the reliability of results, and the ability of the studies to meet their objectives.
- Provide a guide to the ICH efficacy documents to facilitate user’s access (Annex 2 and 3).”
With regards to quality, the guidance describes 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.
The guideline states that “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.”
Several subsections in the guideline address protocol adherence, methods to reduce or assess bias, safety monitoring and the data monitoring committee.
To read the ICH drafted revised guideline on general considerations for clinical studies, please click here.