Pfizer broadens researcher, patient access to clinical trial data

Pfizer announced that it will expand access to clinical trial information to independent researchers and patients who take part in the studies. The company said it hoped that the enhanced access to its data will boost further scientific and medical research, as well as encourage more patients to enrol in clinical trials.

Under the new initiative, the drugmaker will produce and distribute "lay-language" summaries of clinical trial results to participants who wish to receive them, starting with studies that begin enrolling in 2014. Pfizer added that it is also piloting technology that allows patients to download their own electronic clinical data collected in the trial. Pfizer research chief Mikael Dolsten remarked "we are proud to be, I think, the first company to take this step."

Steve Romano, head of Pfizer's medicines development group and specialty care unit, said "we've had patients ask for information for many, many years and I think one way of making them feel that the value that they brought to the whole development process is in fact recognised is to get information back to them." Romano added "as far as changing the mindset of patients getting involved in clinical trials, which has always been a challenge, this will help quite a bit."

In addition, the company said that it will allow "qualified researchers" to request access to anonymised patient-level data from its clinical trials. Pfizer indicated that it will establish an external independent review panel to consider requests that have been denied or only partially approved by the company, with the panel making a final decision.

In July, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) detailed commitments under which drugmakers will increase the amount of clinical trial information available to researchers, patients and members of the public. The move followed draft guidance from the European Medicines Agency on the publication and access to clinical trial results, which is expected to come into force at the beginning of 2014.

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