The US Food and Drug Administration (FDA) has started its public consultation for the International Council for Harmonisation (ICH) guideline on good clinical practice (GCP) and has requested feedback on the guidance, which would help modernize clinical trials.
The ICH draft guideline was published in late May, and serves as an update for the E6(R2) version of the guideline that was adopted by the FDA in March 2018. Despite the E6(R2) covering the areas of emerging technology and electronic data sources, after its adoption, ICH decided to address innovative trial designs and diverse data sources in E6(R3). (RELATED: E6(R3): ICH releases draft of overhauled GCP guideline for consultation, Regulatory Focus 25 May 2023)
The goal of the E6(R3) draft guideline is to modernize clinical trial design and conduct and enable the introduction of “rapidly developing technological and methodological innovations” in clinical trials, according to the agency…
