While PhRMA, EFPIA and other trade groups have established positions on trial data transparency, Big Pharma consortium TransCelerate BioPharma has been on the periphery of the public debate. Behind the scenes though it has been looking into the best way to redact information--and has shared its thoughts on the topic with the European Medicines Agency (EMA).
The extent to which biopharma companies will be allowed to redact information is one of the big remaining controversies in the row over transparency in Europe, with the ombudsman questioning why EMA's recent policy allows for the removal of "significant information." TransCelerate is working from the position that some redaction will be needed, with its project coming in response to a paper from PhRMA and EFPIA that called for "appropriate" deletions. Protecting the privacy of patients, investigators and clinical trial staff is the stated goal of TransCelerate's transparency working group.
Senior staff at EMA have been privy to the approach proposed by the working group, which seeks to find the best, most efficient way to redact information. An evolution in the principles underpinning the writing of clinical study reports is one of its areas of focus. The group is also working on ways to anonymize--and de-identify--patient-level data, the results of which will be shared and have implications beyond trial transparency. Doubts over the ability of Britain's National Health Service to protect patient privacy was one of many concerns that set back its database plans.
TransCelerate has also added a program to develop a framework for a clinical trial quality management system (QMS) to its list of initiatives. The project takes its cue from drug production, an activity that already uses QMS to control quality. By applying the idea to clinical trials TransCelerate hopes to put a stop to the recurring regulatory failings that affect research.
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