Podcast: Renovating ICH Guidelines to Support the Evolution of Clinical Research
June 28, 2021 | Oracle Health Sciences – The Latest Dose Podcast
The clinical research ecosystem has undergone an incredible evolution over the past 18 months, and many want it to continue. To help set the industry on a solid path forward, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has created guidelines that provide direction on behaviors and actions to take.
Recently, an ICH working group referred to a specific set of these guidelines, ICH E6 Revision 3 and E8 Revision 1, as being under renovation in response to the way work is done today and in the future, including innovative clinical trial designs, increasing use of digital components, and advancing evidence generation. In episode 17 of The Latest Dose, host Kathy Vandebelt speaks with Andy Lawton, director at Risk Based Approach Ltd., Crissy MacDonald, vice president of client delivery at WCG Avoca, and Erika Stevens, principal at Recherche Transformation Rapide, about these specific ICH guidelines to learn what is new and improved about the quality by design (QbD) approach, how this will impact the future of clinical research, and what you need to do to prepare.