With pressure mounting on drugmakers to make clinical trial data more transparent, Pfizer ($PFE) has started to take steps to open up its results. Having given the world a brief look at its plans to let patients access their data in September, this week it unveiled more concrete details and a timeline for adoption.
Previously announced plans to allow patients to download their clinical trial data will come into force at the start of next year. The feature makes use of the "Blue Button" standard developed by the White House to help patients take control of their personal health records. Pfizer is also making use of the standard in its recently revealed plans to soup up ClinicalTrials.gov. Both initiatives are intended to encourage people to take part in clinical trials, either by matching them to a study or giving them more reasons to participate.
"We've had patients ask for information for many, many years and I think one way of making them feel that the value that they brought to the whole development process is in fact recognized is to get information back to them," Steve Romano, head of Pfizer's medicines development group, said at a media day attended by Reuters. Pfizer will also distribute lay-language summaries of trial results to patients who enroll in studies from next year onward.
The company is trumpeting the move to give patients their own results as something that sets its project apart from other Big Pharma initiatives, like GlaxoSmithKline's ($GSK) push to give researchers data. Pfizer has included researchers in its plans too, though. From next year Pfizer's website for investigator-initiated studies will include a standard form with which researchers can request anonymized patient-level data. The final decision whether to approve the request will rest with an independent panel of academics.
- here's Reuters' article
- read the press release