ICH Guideline E8 (R1) on General Considerations for Clinical Studies

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 blog provides general 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

General principles

1. Protection of clinical study participants

Important principles of ethical conduct of clinical studies and the protection of participants, including special populations, have their origins in the Declaration of Helsinki and should be observed in the conduct of all human clinical investigations.

The investigator and sponsor have responsibilities for the protection of study participants together with the Institutional Review Board/Independent Ethics Committee. The confidentiality of information that could identify participants  should be protected in accordance with the applicable regulatory and legal requirement(s).

Before initiating a clinical study, sufficient information should be available to ensure that the drug is acceptably safe for the planned study in humans. Emerging non-clinical, clinical, and pharmaceutical quality data should be reviewed and evaluated, as they become available, by qualified experts to assess the potential implications for the safety of study participants. Ongoing and future studies should be appropriately adjusted as needed, to take new knowledge into consideration and to protect study participants.

2. Scientific approach in clinical study design, planning, conduct, analysis, and reporting:

Clinical studies should be designed, planned, conducted, analysed, and reported according to sound scientific principles to achieve their objectives. The purpose of a clinical study is to generate reliable information to answer the research questions and support decision making while protecting study participants.

Quality by design in clinical research sets out to ensure that the quality of a study is driven proactively by designing quality into the study protocol and processes.

3. Patient input into drug development

Consulting with patients and/or patient organisations during drug development can help to ensure that patients’ perspectives are captured. Involving patients early in the design of a study is likely to increase trust in the study, facilitate recruitment, and promote adherence. Patients also provide their perspective of living with a condition, which may contribute to the determination, for example, of endpoints that are meaningful to patients, selection of the appropriate population and duration of the study, and use of acceptable comparators. This ultimately supports the development of drugs that are better tailored to patients’ needs