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Brainstorm: How can we fix the global clinical trial registry system?

08 September 2022 at 18:00-19:00 CEST (Berlin time) / 17:00-18:00 London time

Video | Transcript

The global network of 17 clinical trial registries provides the world’s only comprehensive overview of who is researching which medical treatments. Whether it’s a funding agency trying to decide where to target its resources, or a patient trying to find trials to enrol in, registries are indispensable. But the entire system is riddled with inconsistent, incorrect and out-of-date data, slowing down trial recruitment, undermining health policy making, and fuelling costly research waste. This seminar brings together registry managers and data users to jointly brainstorm realistic and practical options for improving individual registries and the system as a whole.

 

Participants:

Till Bruckner, PhD

Senior Policy Researcher 

Till Bruckner is the founder of TranspariMED, a campaign that works to end evidence distortion in medicine, and a Research Fellow at the QUEST Center for Responsible Research. His work focuses on regulatory transparency and clinical trial registration and reporting. He previously worked for the AllTrials campaign, the Transparify think tank initiative, the anti-corruption group Transparency International, a commercial microfinance consulting company, and various international development NGOs. Till holds a PhD in political science from the University of Bristol.

Nicholas DeVito, DPhil
 
Nicholas DeVito is a postdoctoral researcher in health policy at the Bennett Institute for Applied Data Science at the University of Oxford. Nick recently completed his DPhil at Oxford on the impact of clinical trial registries on transparency and accountability with a particular focus on compliance with legislative requirements to report in the US and EU.

Perrine Janiaud 

Perrine Janiaud is a researcher at the Research Center for Clinical Neuroimmunology and Neuroscience Basel and at the Department of Clinical Research at University of Basel and University Hospital Basel, in Switzerland. She is a trained clinical epidemiologist and her research focuses on clinical trial methodology, more specifically pragmatic trials, real world evidence and more broadly meta-research. She was one of the lead investigators for COVID-evidence a living database of all planned, ongoing, completed, and published COVID-19 randomized controlled trials.

Gayatri Saberwal 

Prof. Gayatri Saberwal is a faculty member and Dean at the Institute of Bioinformatics and Applied Biotechnology (IBAB) in Bangalore. She did her PhD in the life sciences at the Centre for Cellular and Molecular Biology, Hyderabad, and then did post-doctoral work at at the Weill Medical College of Cornell University, New York. She has worked on various aspects of public health policy, and is currently focussed on determining what clinical trial registries can, and cannot, tell us.

Thomas Wicks

Thomas Wicks is the Head of Data and Partnerships at Informa Pharma Intelligence, where he is responsible for the organization’s data governance and interoperability as well as tracking regulatory requirements and clinical data sharing trends that shape the company’s clinical transparency solutions and services. He has over 25 years of experience with compliance management solutions, specializing in applications for life sciences with a focus on clinical trial disclosure and transparency since 2007.

C Marc Taylor 

Marc Taylor chairs the not-for-profit company which owns the ISRCTN registry. Based in the United Kingdom, ISRCTN is a primary clinical trials registry in the WHO system. BMC, part of Springer Nature, maintains and publishes it under contract. Marc has chaired ISRCTN since he retired in 2011. For ten years, Marc led system reforms in the regulation, governance, management and funding of health research in England. He was a member of the team at the Department of Health which established the National Institute for Health Research and the Health Research Authority. As an official he took part in setting up the UK Research Integrity Office and the ISRCTN registry. Until 2022 Marc was a member of the HRA’s audit and risk committee. His earlier career in the Department of Health gave him a strong background in health service finance, building on what he learnt in the 1980s as a budget holder for official British development assistance programmes. He headed the development section of the British High Commission in India in 1986-9. Marc is a British and French citizen.

Deborah Zarin 

Deborah Zarin is currently the Director of the Program for Advancement of the Clinical Research Enterprise at the MRCT Center of Brigham and Women’s Hospital and Harvard. Prior to that, she was the Director of ClinicalTrials.gov. Dr. Zarin has focused her career on applying evidence to improve the quality of critical clinical, policy and research decisions. Specific positions have enabled her to focus on clinical decisions in psychiatry, payment and coverage decisions for the Medicare program, and overarching issues related to the reporting and conduct of clinical trials.

As the Director of ClinicalTrials.gov at the National Institutes of Health, she led the development of the world’s largest trial registry, contributed to a series of policy initiatives in the US and internationally designed to improve the reporting of clinical trials, developed the first ever structured database of summary trial results, and oversaw the implementation of Section 8 of the Food and Drug Administration Amendments Act (FDAAA) that mandates the reporting of most clinical trials conducted at US academic medical centers, as well as trials conducted by industry throughout the world.

In addition to serving as a key advisor for the various policies and overseeing the development and operations at ClinicalTrials.gov, she led a research program focused on improving trial reporting policies, and using data generated from ClinicalTrials.gov to analyze issues within the clinical research enterprise that interfere with the optimal generation of evidence to guide clinical and policy decisions. 

Since joining the MRCT Center, Dr. Zarin has focused on improving the quality of clinical trials, as well as the quality of clinical trials reporting. She worked with colleagues to develop a framework for understanding the sources of uninformative (low value) clinical trials and is now engaged in several research projects to identify points of leverage for decreasing the initiation of low value trials.

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