A lot has changed in clinical trial transparency since Project Data Sphere outlined plans to share cancer results in 2012, with the European law voted in last week then still a distant threat. Even so, Pfizer ($PFE), Sanofi ($SNY) and the other groups behind the initiative think it still offers something different now that it has belatedly launched.
Pfizer and Sanofi have joined with AstraZeneca ($AZN), Bayer, Celgene ($CELG), Johnson & Johnson ($JNJ) and Memorial Sloan-Kettering Cancer Center to set up Project Data Sphere. Together, the groups have contributed comparator-arm data from 9 clinical trials, with results from more studies and organizations to follow soon. Focusing on comparator-arm data made it easier to get companies to join the initiative because fears about giving away proprietary information are reduced.
The decision also limits the usefulness of the database--it isn't the trove of data on marketed drugs that transparency campaigners want--but it can nonetheless play a role in improving development. "Understanding the expected outcome for a comparator arm is a very important step in designing new clinical trials. It will help with physical assumptions, the sizing of a trial, and other design logistics," Pfizer's oncology medical affairs lead, Ronit Simantov, told PharmExec.
At this stage nobody is quite sure of the full potential of the data. "In silico" comparator arms for new trials are one possibility, but this and other ideas still need testing. By making the deidentified clinical trial data available to everyone--and providing built-in analytics tools from SAS--the Big Pharma allies hope to tap into the research community's capabilities. A series of research challenges, starting with a prostate cancer-focused project, are planned to stimulate this work.
|Sanofi CMO Charles Hugh-Jones|
The project has received slight criticism for only including comparator-arm data, but the partners were aiming to create a useful resource, not further the transparency agenda. Having met their initial target, the partners are now working to expand the database--the goal is to have data from 25,000 patients within a year--and add social tools. "My belief is that [we] will be maximally successful once we start to build in the social overlay, because then everyone--payers, researchers, companies, academia and others--can start talking to each other," Sanofi CMO Charles Hugh-Jones told PharmExec.