Explore how life sciences and biotech consulting can help you implement the new ICH E6(R3) Good Clinical Practice for effective clinical trials.
The new ICH Good Clinical Practice (GCP) E6(R3) is the major revision of the previous version, embracing many new concepts and approaches in ensuring the quality of clinical trials. It allows the assurance of better safety and ethics within clinical trials with new guidelines in place.
Following are some of the main elements of the new guidelines:
Quality by design:
This is a new concept that revolves around the designing of clinical trials to be as high quality as possible. The techniques used in the selection of the population for the study, design of the protocol of the study, and application of methodologies in the collection and analysis of data are considered. It is applied systematically for the quality of a clinical trial. It is particularly important to identify and mitigate potential sources of error or bias at every step of the clinical trial process, from design to data analysis.
Risk-based monitoring:
It is a novel approach to monitoring clinical trials in terms of identifying and managing the risks to the trial’s quality. This encompasses issues like the gravity of the trial, the potential for harm to participants, and the prospects of bias. This approach is more proactive in monitoring clinical trials compared to the former reactive monitoring. Identifying and assessing the risks to the quality of the trial and then taking steps to mitigate those risks is implied by the foregoing.
Proportionality:
This is a new principle that heralds the practice of clinical trials being proportionate to the risks and benefits of the trial. It includes the size of the trial, the duration of the trial, the quantity of data that is anticipated, and the available resources. This principle identifies the fact that not all clinical trials are equal. Some trials are more complicated and riskier than others. The new guideline gives renewed emphasis to conducting the trial in a proportionate way with respect to the risks and benefits involved in the trial.
Critical to quality factors:
This new concept identifies what is important to ensure the quality of a clinical trial. It highlights aspects that should be given special attention during the planning, execution, and monitoring of the trial. These factors are among the most significant issues regarding quality clinical trial performance. They include staff study training, the quality of the data, and the independence of the committee responsible for monitoring amongst other critical factors.
The following are the steps to follow the new ICH GCP E6(R3):
Review the Draft Guideline
A draft guideline of the ICH is available on its official website. Identify changes that need to be made to your clinical trial practices. The new draft guideline introduces numerous changes from the version previously in use. Identify any changes to your clinical trial practices to comply with the new requirements.
Clinical trial document update:
After you identify changes for implementation, you will need to update your clinical trial documentation. This may include your informed consent documents and study protocols, amongst others.
Train your staff
In case of new GCP requirements, it is advisable that you train your staff in them to ensure that your clinical trials run in compliance.
Monitor your clinical trials.
After you have launched your clinical trials, you must monitor them to comply with the new GCP requirements.
Implementation tips for the new ICH GCP E6(R3).
Plan to get started early. It is not necessary to wait until the last minute to implement the new requirements. You have enough time to review the draft guidelines and make any decisions on changes you would like to include in your documentation.
Have the experts help you. If you have to implement the new requirements of GCP, many resources could be put forward for you. In this regard, the ICH website publishes a list of accredited training providers and there are also consultants that specialize in GCP compliance.
The new ICH GCP E6(R3) is a comprehensive guideline providing people with guidelines on how to conduct clinical trials in a safe and ethical manner. It is an essential resource for researchers, sponsors, and regulatory authorities.
Feel free to contact us at BioBoston Consulting today or visit our website for further information about how we can support your organization.