By Fadwa Dabbah-Assadi
Since 2016, emerging technological innovations have made clinical trial designs more diverse and complex, and increase the risk that stakeholders may fail to comply with the present/former E6(R2) guidelines.1 Consequently, the E6(R2) guideline was amended to the E6(R3) guideline (endorsed on 19 May 2023) by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to allow easier and appropriate application in complicated innovative clinical trial design and conduct. E6(R3) guidelines include the use of an investigational product (IP) in a controlled setting, with prospective treatment of participants and appropriate data gathering in non-traditional interventional clinical trials, guaranteeing consistency and full adherence to GCP guidelines that comply with the global regulatory environment.2
Innovative digital health technologies such as wearables and sensors may greatly influence trial conduct due to increased reliance on electronic systems (especially those with remote monitoring). These technologies could be integrated into current clinical healthcare infrastructures, allowing a wide range of data sources, data capture, and data gathering.
In particular, the new E6(R3) guidelines focus on the need to identify critical quality elements, building quality by design (QbD), reliability of clinical trial results, simplifying informed consent, and ensuring representative study participants. In addition, E6(R3) guidelines allow the use of the various new technologies mentioned above for proper clinical documentation (source records which should be accompanied by relevant metadata) and risk management processes while protecting trial participants.
To summarize, E6(R3) guidelines provide stakeholders with a complete package that will replace E6(R2), enhancing robustness and increasing flexibility of GCP principles, thereby opening the way to using a variety of instruments and methodologies that are customized and fit-for-purpose in any future clinical study.
- E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry.
- ICH E6 (R3) Guideline on good clinical practice (GCP)_Step 2b.