Time to Review ICH GCP Guidelines, Say ICR Members
According to a recent Institute of Clinical Research (ICR) poll, more than 80% of its members would like the ICH GCP guidelines to be revised. Unlike other guidelines, such as the Declaration of Helsinki, ICH GCP, which describes the responsibilities and expectations of all participants in clinical trials, has not been updated since its implementation in 1996.
“The opinion expressed by our members was that some areas of ICH GCP should remain unchanged as they are still very relevant to clinical research today," said Sue Fitzpatrick, CSci, ICR's education manager, "however, certain amendments would be welcomed and would ensure the guidelines are still meeting the needs of the industry.”
Areas suggested for review by ICR members included: harmonization and globalization; clarifications and interpretation; scientific developments; and data protection.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
The Rise of Predictive Engagement Tools in Clinical Trials
November 22nd 2024Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.
