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.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.