The International Council for Harmonisation (ICH) has issued draft guidance designed to provide the pharmaceutical industry with the flexibility to incorporate innovative approaches into clinical trial designs. This move signals a potential shift towards more adaptive and efficient clinical research methodologies.
The draft guidance addresses various aspects of clinical trial conduct, including the possibility of obtaining informed consent remotely where appropriate. This suggests a move towards decentralized clinical trials, potentially improving patient access and reducing the burden of participation. The ICH's initiative reflects a growing recognition of the need to modernize clinical trial processes to accelerate drug development and enhance patient outcomes.
