Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
Transparency and access to research data is a key feature of modern research policy, impacting data quality and the robustness of results, and allowing the optimal use of data generated by research projects.
Although the forms of open data access may vary across disciplines, the theme of data accountability and transparency applies broadly to any type of research activity. It is of particular importance for research receiving public funding. The debate around transparency in clinical trials involves additional factors (e.g. consent and protecting privacy) and many different stakeholders. Although various organisations have endorsed the principle of providing the scientific community with access to individual participant data from clinical trials, and several initiatives promote data sharing and have provided recommendations, a global consensus is needed. Within the H2020-funded CORBEL project, ECRIN (the European Clinical Research Infrastructure Network) working with a large, international group of experts, produced a consensus document listing clear, broadly based and pragmatic recommendations supporting the sharing and reuse of individual-participant data from clinical trials.
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About the speakers...
Christian Ohmann is a mathematician by training; he received the habilitation in Theoretical Surgery and has over 30 years of experience in clinical trials and clinical research informatics, as Head of the Theoretical Surgery Unit at the Heinrich-Heine-University of Düsseldorf first and then as Scientific Head of the Coordination Centre for Clinical Trials in the same University, until 2014. Retired, he is now working for the European Clinical Research Infrastructures Network (ECRIN) as a chair of Network Committee and chair of Independent Certification Board; he also represents ECRIN in several H2020 funded projects such as CORBEL.
Rita Banzi is the Coordinator of the Centre for Drug Regulatory Policies at the Mario Negri Institute in Milan. She received her BS in Pharmaceutical Chemistry from the University of Bologna and completed her PhD in Pharmaceutical Sciences at the same University. She’s been working at Mario Negri since 2007 as staff of the Italian Cochrane Centre for the development of systematic reviews and ECRIN European Correspondent for Italy. She has an extensive experience and expertise in clinical research systematic review methodology and appraisal of mechanisms of marketing approvals of drugs in Europe.
Steve Canham is an IT consultant specialized in clinical trial data systems and data management, with 16 years' experience with clinical research systems. From 2002 - 2011 he was the Head of the IT team at the trials unit at the Institute of Cancer Research, London. He is currently Secretary to the ECRIN Independent Certification Board for data centres, Chair of ECRIN standards review, ECRIN auditor and member of the UK's international Registration Panel for clinical trials units. Steve is also involved in several H2020 projects on behalf of ECRIN.