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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
