5AM began working with Pfizer in 2013. 5AM contributed to piloting the concept of delivering data collected during their clinical trials directly back to the individual patients over the Internet. The project was propelled by several factors:
- The first was compliance with US, Canadian and European Informed Consent policies of Pfizer that authorize patients to receive data if requested.
- The second is a movement by industry to support data transparency—that is the publishing of clinical trial data that traditionally has been kept tightly under wraps.
- The third is that since 2009 with the enactment of the HITECH Act in the US, there has been heavy investment to support the adoption of electronic health records.
One result was a White House technology standards initiative to promote the “blue button” concept to allow individuals to view, download, and transmit their medical records and to foster communication between patients and their caregivers.
5AM collaborated with Pfizer (the sponsor) and United Biosource Corporation (the safe harbor) to implement the standard, integrate the systems of Pfizer and UBC, and create a data service that can routinely perform this service for the 150,000 current patients enrolled in clinical trials for Pfizer that is expected to grow annually. Within three months (July 2013 – Sept 2013) we were able to develop, test and distribute the service to Pfizer. This is record time in Pfizer’s experience with external technology companies. We have delivered several iterations since our first engagement.