Transparency of clinical trials data
This document contains an overview of current rules on access to clinical trials data, an overview of the anticipated legislative changes and a summary of the issues that the new regulation may bring, including concerns raised by the industry. This is an area of considerable interest to the industry at large and to many clients, and is one that Allen & Overy is following in detail.
Information on clinical trials is accessible to the public through the EU Clinical Trials Register website, launched by the European Medicines Agency (EMA). The register provides public access to the following information: interventional adult clinical trials for medicines, phase II to phase IV, which were authorised in the EU member states or the EEA; and clinical trials authorised to be carried out outside the EU if these trials are part of a paediatric investigation plan.
Specifically, the register contains information on trial identification, identification of the sponsor, information on each investigational medicinal product, information on placebo, objective, scope, trial type and phase and design of the trial. The information available dates back to 2004…
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