May 30, 2017What's New
This is a must for those interested in clinical trials of the future.
Recommendations from the Clinical Trials Transformation Initiative (CTTI) Registry Trials Project were publicly announced last week in a CTTI-hosted webinar. The recommendations describe how to design new registries or evaluate and modify existing registries to conduct clinical trials suitable for regulatory purposes. By applying these recommendations, stakeholders can make registries into reusable platforms for clinical trials. CTTI has invited interested parties to consider the application of these recommendations in their clinical trials, and encourages sharing the recommendations and webinar recording with colleagues.
The Team Leaders on the project included: Dawn Flick (Celgene), John Laschinger (FDA), Ted Lystig (Medtronic), and Jimmy Tcheng (Duke)
Team Members included: Chunrong Cheng (FDA), Christopher Dowd (Cystic Fibrosis Foundation), Nicolle Gatto (Pfizer), Lauren Mclaughin (Michael J Fox Foundation for Parkinson's Research), Stephen Mikita (Patient Representative), Kristen Miller (FDA), Daniel Mines (Merck), Jules Mitchel (Target Health), Magnus Petterson (AstraZeneca), Sunil Rao (Duke), Arlene Swern (Celgene), and Emily Zeitler (Duke)
Project Managers: Sara Calvert and previously Steve Mikita
John Laschinger, MD, Medical Officer, Center for Devices and Radiological Health, US Food and Drug Administration
Jules Mitchel, MBA, PhD, President, Target Health Inc.
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors.
Joyce Hays, Founder and Editor in Chief of On Target
Jules Mitchel, Editor