The ICH E8(R1) draft Guideline on General Considerations for Clinical Trials reached Step 2b of the ICH Process in May 2019 and has entered the public consultation period. The modernization of ICH E8 is the first step towards the GCP Renovation initiated in 2017.
The International Council for Harmonisation, ICH, is proposing a modernization of ICH E8 in order to incorporate the most current concepts achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials. The revision proposes to:
identify a basic set of critical-to-quality factors that can be adapted to different types of trials to support the meaningfulness and reliability of trial results and to protect human subjects;
address a broader range of trial designs and data sources;
provide an updated cross-referencing of all other relevant ICH Guidelines that should be referred to when planning clinical studies.
Topics and structure of the ICH draft
The draft document covers the following topics:
GENERAL PRINCIPLES, including the protection of clinical study subjects, scientific approach in clinical study design, conduct, and analysis, patient input into study design.
DESIGNING QUALITY INTO CLINICAL STUDIES, e.g. by applying Quality by Design (QbD), including processes that ensure Data Integrity (DI), critical-to-quality factors & approaches to identifying the critical-to-quality factors.
DRUG DEVELOPMENT PLANNING for non-clinical studies & clinical studies, including quality & formulation of Investigational Medicinal Products (IMPs), & feasibility.
DESIGN ELEMENTS FOR CLINICAL STUDIES, including study design & study data.
STUDY CONDUCT AND REPORTING, including training, data management, access to interim data, safety monitoring, Data Monitoring Committee (DMC) & clinical study reports.
CONSIDERATIONS IN IDENTIFYING CRITICAL-TO-QUALITY FACTORS.
In addition, the draft document comprises 3 Annexes:
Annex 1: TYPES OF STUDIES (i.e. Non-clinical testing, Human Pharmacology, Exploratory, Confirmatory, Post-Approval)
Annex 2: ICH E FAMILY OFGUIDELINES
Annex 3: SELECTED EXAMPLES OF CRITICAL-TO-QUALITY FACTORS, including randomization, blinding/ masking, data quality, procedures supporting study endpoints and Data Integrity (DI), informed consent, training, data recording and reporting, data monitoring and management, statistical analysis, and delegation of sponsor responsibilities.