Big Pharma Companies Open Up Cancer Trial Comparator Arm Data

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.