Essential clinical study documents (first of all, clinical study reports, protocols and related amendments, statistical documents, and case report form templates) on new human medicines authorized in the European Union are now available at EMA’s website. In addition, such registration dossier modules as clinical overviews and clinical summaries will also be made publicly available. The published materials will include initial MA applications submitted to the agency after January 1, 2015, or those submitted to vary a marketing authorization for an extension/modification of indication or a line extension. Clinical data for two medicines is now made publicly available by EMA. This event has become a really important step in global clinical research development and here is why.
Opening up clinical data encourages transparent relations between all industry participants and guarantees a fair approach to customers, which is of utmost importance. It is expected that EMA will focus its efforts on making clinical research information available for non-specialists. This step is also expected to assist healthcare workers in making treatment decisions by providing them with an enormous scope of information and serving as an independent filter to promote effective medicines. Finally, it will also facilitate work of pharmaceutical manufacturers by reducing duplication of research and risks in new drug developments.
But the most significant consequence of this decision is that it will accelerate drug development process and benefit academic research and the practice of medicine as a whole. Considering the fact that many EU countries conduct important international research programs, data of thousands of trials held by hundreds of companies will provide the basis for re-analysis of data and further inform regulatory decision making in the future.
This step initiated by EMA is just a beginning. We in OCT believe that this is the beginning of the whole new era of clinical trials when every mistake, inaccuracy or omission in a clinical research project can be identified and become publicly available. We also believe that this will boost market consolidation by filtering non-experienced vendors, thus increasing the trust of sponsors in CROs and the confidence of customers in regulatory authorities and pharmaceutical market in general.
Dmitry Sharov, OCT President