Access to full data sets from clinical trials will benefit both large and small biopharmaceutical companies and researchers, according to an article published in the New England Journal of Medicine by four members of the EMA staff, including its executive director and senior medical officer.
“A managed-release environment that allows sharing of patient-level data while ensuring patient privacy would create a level playing field for all stakeholders,” said the authors.
In Access to patient-level trial data—A boon to drug developers, the authors argued access to complete clinical trial data, including patient-level data, will achieve the following:
In response to concerns related to the risk of misinterpretation of clinical trials, the authors said inappropriate secondary data analyses are likely to occur regardless of the nature of the data. To address this risk, they call for a two-way transparency principle by which any secondary analysis is also to be published and subject to critical review.
The EMA recently published a draft policy on publication and access to clinical trial data, including patient-level data. The agency currently is reviewing the comments received on the draft policy as part of the three-month public consultation phase that ended Sept. 30.