EMA calls for sponsor and CRO input on trial data publication plan
The European Medicines Agency (EMA) has scheduled a meeting on November 22 and has invited academic and industry stakeholders to help it “define the modalities of proactive access to clinical trial data, in a way that best serves patients and public health in an open and transparent forum.”
The idea of data publication hit the headlines again in April following an article in the PLOS journal in which author Peter Doshi, a postdoctoral fellow in comparative effectiveness research at Johns Hopkins University School of Medicine in the US, argued that failing to make all clinical trial data available to the public is hampering independent research.
“Systematic reviews of published randomized clinical trials (RCTs) are considered the gold standard source of synthesized evidence for interventions, but their conclusions are vulnerable to distortion when trial sponsors have strong interests that might benefit from suppressing or promoting selected data.”
Doshi also suggested that – beyond alleged industry suppression of unfavourable clinical trial data – the other part of the problem is that regulators have traditionally treated clinical trials data as confidential.
In a response piece published in the same journal the EMA agreed that clinical trial data should not be kept secret for commercial reasons, but did caution that the publication of raw data sets may breach patient confidentiality rules.
The EMA team went on to say that while publication of study data may have public health benefits they also called for the development of “rules of engagement for sharing raw data, with the same standards applying to all clinical trial data on medicines, regardless of the type of sponsor.”
Sponsors and CROs interested in the development of these rules can find out how to register for the EMA meeting here.
