First produced in June 1996, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) is an internationally agreed standard that ensures ethical and scientific quality in designing, recording and reporting trials that involve human subjects. The objective of the standard is to ensure that the rights, safety and well-being of the individuals recruited for these trials are protected and that clinical trial data are credible and reliable, regardless of where in the world the trials have been carried out.
In November 2016, for the first time in 20 years, ICH GCP was updated by means of an addendum that provides additional guidance without altering the existing text. Now that we are in the implementation phase of the ICH GCP revision, it may be a good idea for biotech and specialty pharma innovators to review the key principles of ICH GCP and how they have been updated to reflect the realities to today’s clinical trial landscape.
The Principles of ICH GCP
There are 13 principles and they can be summarized as follows:
- Clinical trials are conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
- Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
- The rights, safety and well-being of the trial subjects are the most important considerations and should prevail over the interests of science and society.
- The available non-clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
- Clinical trials should be scientifically sound and described in a clear, detailed protocol.
- A trial should be conducted in compliance with the protocol that has received prior Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approval or favorable opinion.
- The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
- Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s).
- Freely given informed consent should be obtained from every subject prior to clinical trial participation.
- All clinical trial information should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification. The ICH GCP addendum adds to this principle, stating that it applies to all records referenced in the guideline, irrespective of the type of media used. This addendum is aimed at advances in technology—the proliferation of the internet, smartphones, electronic data capture, real-time review of clinical data—that have fundamentally changed the conduct of clinical trials.
- The confidentiality of records that could identify subjects should be protected respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
- Investigational products should be manufactured, handled and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
- Systems with procedures that assure the quality of every aspect of the trial should be implemented. The addendum emphasizes that aspects of the trial that are essential to ensure human subject protection and reliability of trial results should be the focus of such systems. In other works, these systems should be risk-based.
These are top-level principles which need to be interpreted and translated into good clinical research practice, which can be significant for biotech and specialty pharma innovators who are resource-constrained and often new to the clinical trial area.
While a sponsor may transfer any or all of their extensive duties to a contract research organization (CRO), responsibility for the quality and integrity of a clinical trial ultimately lies with the sponsor. With the significant changes to the standard in the recent revision, all sponsor personnel and investigative sites with trial-related duties and functions should receive appropriate and timely training on the updates.
To learn more, read our white paper ICH GCP E6 (R2): A Primer for Small Biotech and Specialty Pharma Companies.