This webcast is part of the 2006 Global Strategies for Clinical Research Information 2006 series sponsored by CDISC and AMIA.
Learning Objectives
Participants will:
- Learn the purpose and value of registering all clinical trials at inception
- Hear a status update on the progress of the International Clinical Trials Registry Platform project
- Gain a thorough understanding of the project goals going forward
- Hear how CDISC and HL7 are involved in this project
Program content
Ensuring transparency of clinical research information and increasing public trust in clinical trial conduct will rely on having openly available clinical trial registries.
The World Health Organization (WHO) has taken the global lead in setting international norms and standards for trial registration and reporting; they have initiated the International Clinical Trials Registry Platform project. The project leader, Dr. Ida Sim, will present a webcast describing the objectives and progress of this important activity.
Who Should Attend?
This session is intended for Biopharmaceutical Industry leaders, Clinical Project and Program Managers, and all others who are interested in global trial registration.
For instance, these professionals may also gain valuable information from this session:
- Medical communications personnel (Medical writers)
- Journal Editors
- Consumer Advocates
About Ed Helton, PhD, SAS; and Ida Sim, MD, PhD, World Health Organization
Edward D. Helton, Ph.D. (moderator), is the Chief Pharmaceutical and Regulatory Strategist at SAS Institute. He is responsible for guidance and compliance of SAS software in the pharmaceutical industry. Prior to joining SAS, Dr. Helton was a Senior Clinical Study Director in the Neuroclinical Trial Center at the Virginia Neurological Institute. As Vice President of Regulatory Affairs for Quintiles Inc., he was responsible for global drug submissions, a position that allowed him to build upon his already-extensive experience working with the FDA.
Dr. Helton has continued his scientific research and has been closely involved in both the design and FDA submission of pharmacokinetic, efficacy and safety data of recombinant drugs, synthetic peptides, endogenous products and low molecular weight lipophilic xenobiotics.
Ida Sim, MD, PhD (speaker) is an Associate Professor of Medicine in General Internal Medicine and Associate Director of Medical Informatics for the Program in Biological and Medical Informatics at the University of California San Francisco. She received her MD and her PhD in Medical Informatics from Stanford University, and her Primary Care Internal Medicine training from the Massachussetts General Hospital. She is also fellowship-trained in General Internal Medicine at Stanford University. Dr. Sim's primary research interest is the design and use of clinical trial reporting systems for scientific analysis and evidence-based practice. As the Project Coordinator of the World Health Organization's International Clinical Trials Registry Platform project, she is a leading expert on the scientific and technical issues surrounding clinical trial registration and results reporting worldwide.
