Clinical Trial Data Sharing: Landscape, Trends, and Risks


The Clinical Trial Data Sharing Landscape
 
The potential benefit of sharing clinical trial data (patient-level data and clinical documentation) has been recognized by various industry groups over the past several years, but the reality of sharing data is emerging. While several successful initiatives have launched, e.g. the Coalition Against Major Diseases (CAMD), and contributed to the cumulative trend to share data, recent industry commitments and policy decisions have propelled this effort in a significant way.
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The Efficiency of Bringing Drugs to Market Versus the Fairness of Making Drugs Accessible


As the 2014 Ebola outbreak continues to spread in West Africa, drug companies, national governments, and public health entities as a whole are coming under increasing criticism for failing to offer what many would view as equitable approaches to addressing public health epidemics, particularly those occurring in poor or developing nations. Indeed, public health threats like the Ebola virus challenge drug companies to find the right balance between making unproven treatments available to desperate populations and ensuring the safety and efficacy of treatments that have yet to undergo comprehensive clinical testing. Furthermore, striking such a balance highlights a medical ethics issue that has haunted some of these drug companies in the past: conducting clinical trials on foreign populations with few of the ethical and safety protections required by western cultures, yet then pricing drugs out of the market for these same populations once they are FDA approved.
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New EU Clinical Trials Regulation


On 16 June 2014 a new Clinical Trial Regulation entered into force in Europe. It will apply no earlier than 28 May 2016.
 
The new regulation presents a major step forward in harmonizing clinical trial assessment process in the EU. For years, Europe was criticized for having too complicated, non-harmonized, nationally driven procedures for clinical trial assessment which often resulted in timely unpredictable and divergent assessment conclusions. Sponsors were faced with numerous country-specific protocol amendments as result of different opinions of one-country’s Competent Authority and Ethics Committee compared to opinions of other EU countries or even different opinions of Ethics Committee compared to national Competent Authority of the same country. In any case, Sponsors could expect any combination of decisions and close follow up by national experts was necessary.
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