Drugs

ICH Good Clinical Practice Guide Comments

The International Council for Harmonization (ICH) has released for public comment a draft guideline entitled “ICH Harmonized Guideline — Good Clinical Practice (GCP) E6(R3).” The document is intended to provide a unified standard to facilitate mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities. It builds on key concepts outlined in “ICH E8(R1) General Considerations for Clinical Studies,” including fostering a quality culture and proactively designing quality into clinical trials and drug development planning, identifying factors critical to trial quality, and engaging stakeholders, as appropriate, using a proportionate risk-based approach.

The principles discussed in the document are intended to support “efficient approaches to trial design and conduct,” ICH says. “For example, innovative digital health technologies, such as wearables and sensors, may expand the possible approaches to trial conduct. Such technologies can be incorporated into existing healthcare infrastructures and enable the use of a variety of relevant data sources in clinical trials. This will aid in keeping clinical trial conduct in line with advancing science and technological developments. The use of technology in the conduct of clinical trials should be adapted to fit the participant characteristics and the particular trial design."

Additionally, the guideline says that using innovative clinical trial designs and technologies may help include diverse patient populations and enable wider participation. It also says trial designs may be supported by stakeholder perspectives (patients and healthcare providers). “Their input can increase the likelihood of meaningful trial outcomes, which are relevant to both trial participants and future patients,” it says. “This input will also guide decisions on the feasibility of data collection and assure that participation in the trial does not become unduly burdensome for those involved.”

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