Towards Greater International Transparency of Clinical Trials – Short Term Efforts for Long term Benefits: CIHR Trial Policy 2010

Date: February 24th 2011 from 12pm to 1pm EST

Abstract: In this webinar we shall provide a brief overview of the international trends of transparency of clinical trials (WHO international standards, ICMJE and other journal editors, Ottawa Group, regulators and funders, CIHR-PROCTOR). Subsequently I will describe the CIHR trial policy 2010 and some of its implementation plans and issues.

Prospective registration of protocol items and publication of the full protocol as well as public disclosure of trial findings in peer review journals, complemented with more detailed results including individual participant data (micro-level data) sets on the Internet, are integral part of the effort to achieve higher levels of transparency and accountability of clinical trials. It is expected that this will contribute to more efficient knowledge creation that will produce research of higher quality and integrity.

While trial registration and trial registries are fairly well established, with WHO international standards and a world-wide network of registries, the public disclosure of results and related databases are only starting to form, there are no standards and no acceptable repository for micro-level data. I will discuss some issues and efforts aiming at addressing them particularly in the light of the CIHR trial policy 2010 and hope for a feed back.

Speaker: Karmela Krleza-Jeric, Knowledge Translation, CIHR

Biography: Dr. Krleza-Jeric is public health specialist. She is a Senior Advisor in Knowledge Translation Department at the Canadian Institutes of Health Research. She is an adjunct professor in the Department of Epidemiology and Community medicine at The University of Ottawa; leader of the Ottawa Group, and Regional Editor of the Croatian Medical Journal. Her research interests are broad, covering a variety of topics in health research, knowledge translation, international health, and mentoring. She has a keen interest in clinical epidemiology, transparency and impact of research, as well as in development of related standards.

Dr. Krleza-Jeric received her medical degree from University of Sarajevo, her Masters degree in Epidemiology from A. Stampar School of Public Health in Zagreb and Doctoral degree from University of Zagreb. As a Fulbright visiting scholar she spent a year with the American Health Foundation in New York City while working on her thesis. Over the years, Dr Krleza-Jeric has acted as a consultant to the WHO-EURO and HQ.

Download the slides here.

Link to Canadian Institutes of Health Research website.