ICH E6

ICH E6 (R2) is a set of guidelines developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) for the conduct of clinical trials. The guidelines were updated in November 2016 and are commonly referred to as ICH E6 (R2).

The guidelines provide recommendations for the design, conduct, and reporting of clinical trials, with a focus on improving the quality, reliability, and consistency of data generated from clinical trials. Some of the key areas covered by ICH E6 (R2) include:

• Clinical trial design: This includes recommendations for the design of clinical trials, including the choice of endpoints, sample size calculations, and the use of adaptive trial designs.
• Clinical trial conduct: This includes recommendations for the conduct of clinical trials, including the use of Good Clinical Practices (GCPs), data management, and monitoring.
• Clinical trial reporting: This includes recommendations for the reporting of clinical trial results, including the use of Standard Operating Procedures (SOPs), data sharing, and the reporting of adverse events.

ICH E6 (R2) is widely recognized as the global standard for the conduct of clinical trials and is used by regulatory agencies, clinical trial sponsors, and other stakeholders around the world. The guidelines provide a framework for ensuring the quality, reliability, and consistency of data generated from clinical trials and are an essential resource for anyone involved in the development of new drugs and therapies.

ICH E6 (R2) provides recommendations for the design of clinical trials to ensure the quality, reliability, and consistency of data generated from clinical trials. Some of the key design principles outlined in ICH E6 (R2) include:

• Endpoints: The guidelines recommend the use of appropriate and scientifically valid endpoints to measure the efficacy and safety of a new drug or treatment.
• Sample size: The guidelines provide recommendations for sample size calculations to ensure that the study has adequate power to detect the effects of the treatment being tested.
• Adaptive trial design: The guidelines encourage the use of adaptive trial designs, which allow for the modification of certain aspects of the trial (e.g., sample size, dose regimens) based on the interim data collected during the trial.
• Control groups: The guidelines recommend the use of appropriate control groups, such as placebo or active-comparator controls, to compare the effects of the treatment being tested to a reference group.
• Blinding: The guidelines recommend the use of blinding (single or double) to minimize bias and improve the accuracy of the data generated from the trial.
• Randomization: The guidelines recommend the use of randomization to ensure that treatment assignments are made in a fair and unbiased manner.
• Ethical considerations: The guidelines emphasize the importance of ethical considerations, such as informed consent, in the design of clinical trials.

These design principles outlined in ICH E6 (R2) are intended to ensure that clinical trials are conducted in a scientifically rigorous and ethical manner, and that the data generated from clinical trials are of high quality and can be used to make informed decisions about the safety and efficacy of new drugs and treatments.