GENERAL CONSIDERATIONS FOR CLINICAL STUDIES E8(R1), ICH Consensus Guideline

Clinical studies of medicinal products are conducted to provide information that can ultimately improve access to safe and effective products with meaningful impact on patients, while protecting those participating in the studies. This document provides guidance on the clinical development lifecycle, including designing quality into clinical studies, considering the broad range of clinical study designs and data sources used.

The ICH document "General Considerations for Clinical Studies" is intended to:

1. Describe internationally accepted principles and practices in the design and conduct of clinical studies that will ensure the protection of study participants and facilitate acceptance of data and results by regulatory authorities. 

2. 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.

3. Provide an overview of the types of clinical studies performed during the product lifecycle, and describe study design elements that support the identification of quality factors critical to ensuring the protection of study participants, the integrity of the data, the reliability of results, and the ability of the studies to meet their objectives.

4. Provide a guide to the ICH efficacy documents to facilitate user's access.

This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of ICH regions.

Final version Adopted on 6 October 2021

Table of Contents

1. OBJECTIVES OF THIS DOCUMENT

2. GENERAL PRINCIPLES

2.1 Protection of Clinical Study Participants 

2.2 Scientific Approach in Clinical Study Design, Planning, Conduct, Analysis, and
Reporting

2.3 Patient Input into Drug Development

3.  DESIGNING QUALITY INTO CLINICAL STUDIES

3.1 Quality by Design of Clinical Studies
3.2 Critical to Quality Factors 
3.3 Approach to Identifying the Critical to Quality Factors 
3.3.1 Establishing a Culture that Supports Open Dialogue 
3.3.2 Focusing on Activities Essential to the Study
3.3.3 Engaging Stakeholders in Study Design
3.3.4 Reviewing Critical to Quality Factors
3.3.5 Critical to Quality Factors in Operational Practice

4. DRUG DEVELOPMENT PLANNING 

4.1 Quality of Investigational Medicinal Product 
4.2 Non-Clinical Studies 
4.3 Clinical Studies 
4.3.1 Human Pharmacology 
4.3.2 Exploratory and Confirmatory Safety and Efficacy Studies
4.3.3 Special Populations 
4.3.4 Post-Approval Studies 
4.4 Additional Development 

5. DESIGN ELEMENTS AND DATA SOURCES FOR CLINICAL STUDIES 

5.1 Study Population 
5.2 Treatment Description
5.3 Choice of Control Group 
5.4 Response Variables 
5.5 Methods to Reduce Bias 
5.6 Statistical Analysis
5.7 Study Data 

6. CONDUCT, SAFETY MONITORING, AND REPORTING

6.1 Study Conduct 
6.1.1 Protocol Adherence 
6.1.2 Training 
6.1.3 Data Management 
6.1.4 Access to Interim Data 

6.2 Participant Safety during Study Conduct 

6.2.1 Safety Monitoring 
6.2.2 Withdrawal Criteria 
6.2.3 Data Monitoring Committee 

6.3 Study Reporting

7.  CONSIDERATIONS IN IDENTIFYING CRITICAL TO QUALITY FACTORS 

ANNEX: TYPES OF CLINICAL STUDIES 

Source: ICH Expert Working Group

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