Cochrane Centres call for transparency of COVID-19 clinical studies

Representatives of four Cochrane Centres in Europe have signed an open letter to the European Medicines Agency (EMA) initiated by the German Institute for Quality and Efficiency in Health Care (IQWIG).The letter – which Cochrane Austria, Cochrane France, Cochrane Germany and Cochrane Ireland have signed – calls on the EMA to publish clinical study reports on all drugs and vaccines for COVID-19 in full and immediately on the date of marketing authorisation.Clinical study reports (CSRs) are detailed study documents that pharmaceutical companies provide to regulators such as the EMA as part of the drug approval process. In these reports, which are often thousands of pages long, manufacturers document in detail their clinical studies on the efficacy and risks of new active ingredients. CSRs also contain details on the design, methods and results of the study, down to the level of anonymised data of individual study participants. CSRs are therefore by far the most comprehensive information about a clinical trial.The open letter, addressed to EMA Executive Director Prof Guido Rasi, highlights how the international research community has joined forces to identify or develop, test and evaluate drugs and vaccines to combat the pandemic. It states: “To assess these products further and to accelerate the development of additional products, the fast and full public availability of the information submitted to regulators is of utmost importance. In recent years, the EMA has been a p...
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