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.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
Optimizing Phase III Oncology Trial Recruitment with Data-Driven Insights
February 3rd 2025A pharmaceutical company aimed to launch a Phase III clinical trial for a new oncology drug, focusing on efficient and effective patient recruitment across diverse regions. They evaluated patient populations by analyzing demographics, social determinants of health, and geography. Investigator profiling included practice details, affiliations, referral networks, and clinical trial experience. The final step involved selecting and extracting target lists for implementation.
