Open access to clinical data
EMA released the new policy for open access to the clinical data submitted to the agency during the marketing authorization application process (WC500214989.pdf). This is an important step both for the transparency of the process and for the researcher. On one hand the access to the data will substantiate the scientific reasons behind the marketing authorization process and on the other will made a plethora of clinical data available for analysis and research. These data will have a second life supporting further innovation and facilitating the design of more effective clinical trials reducing the burden on the patients.
The database at https://clinicaldata.ema.europa.eu is still in its infancy and the addition of more trials will require time to allow for the the clearing of proprietary information and of personal details from the documents. However, in view of the application of the Regulation 536/2014 and the creation of a database of the ongoing clinical trial, Europe and the EMA is proving the value of centralizing and sharing the information.