A clinical trial is a scientific study which is conducted to explore the effectiveness and safety of a medical intervention in human volunteer participants. Clinical trials are a vital step for ensuring that only the safest and most effective treatments are made available to patients. However, as clinical research studies deal with human subjects, there are numerous ethical considerations to be taken into account. In order to help protect the safety and well-being of participants, there are various sets of standards and regulations in place, both internationally and at regional levels. The ICH is one such organization setting standards that apply to clinical research at the international level.

What is ICH? Overview of ICH GCP

ICH is the short-form abbreviation applied to 'The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.' The purpose of ICH is to bring together pharmaceutical companies with regulatory authorities to discuss various aspects of scientific research and product development.1 A specific framework developed ICH - ICH E6, more widely known by its name ‘Good Clinical Practice (GCP)’ - sets forth international standards for ensuring scientific and ethical quality and integrity in conducting, reporting, and recording of clinical trials.2

In the United States, following the ICH E6 guideline is not legally mandatory for FDA-regulated drug studies. The FDA recognizes the principles underlying the ICH-GCP and has accepted them as guidance.

What are the objectives of ICH-GCP guidelines?

In short, ICH E6 (ICH GCP) describes standards that apply to improving harmonization amongst research efforts involving human subjects and protecting the rights and well-being of research subjects.

ICH E6 describes standards that apply to Sponsors, Investigators, and IRBs in Clinical Research

ICH was established in 1990 to respond to the increasing globalization of drug development efforts. ICH E6 provides guidelines for good clinical practice (GCP), supporting high-quality and ethical design, conduct, and monitoring of clinical trials involving human subjects. In general, ICH aims to minimize redundant research while encouraging excellence in pharmaceutical product development.

The ICH E6 (GCP) describes standards that apply to sponsors, investigators, and IRBs in clinical research. In the United States, following the ICH E6 guideline is: voluntary for FDA-regulated drug studies, but mandatory for studies conducted outside of the United States.

A primary purpose of the ICH is to: Reduce the need for redundant research

The overall mission of ICH is to promote public health by achieving greater harmonization in research through the development of technical guidelines and requirements for pharmaceutical product development, testing, and registration.

A main purpose of the ICH E6 guideline is to provide a uniform standard that the United States, Japan, and the EU can follow, to help facilitate the mutual acceptance of clinical trial data produced under these different regulatory frameworks.

Further Detail about ICH GCP

ICH is an internationally-recognized non-profit association under Swiss law since 2015, and the organization's mission embodies various aspects of regulations and research procedures. Further information can be found in ICH’s mission statement.1

The ICH GCP plays a significant role in improving the process of gathering and recording data in clinical trials, with wide-ranging impacts on the safety and protection of participants, regulatory compliance, clinical data quality and management, and the overall quality of trials and the results produced. The following links provide two authoritative sources where you can go to find more information about ICH, depending on whether you are in the US or the EU:

EMA (for the European Union): International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) | European Medicines Agency [3]

FDA (for the US): E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) | FDA [4]

References:

[1] https://www.ich.org/

[2] https://premier-research.com/blog-updates-guideline-good-clinical-practice-quick-review

[3] https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/international-council-harmonisation-technical-requirements-registration-pharmaceuticals-human-use

[4] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1