The Future of Clinical Data Sharing is Taking Shape

16 April, 2014, by ClinCaptureTeam

Amazing!!  For profit, companies are recognizing that it’s in their interest to share data. It only takes some careful planning to protect their assets.  The extremely high cost of drug R&D has now made it clear that collaboration is necessary to be successful. We are seeing new efforts to speed up discovery by sharing data, where possible, rather than repeating expensive mistakes separately. Perhaps now the war on cancer can advance more rapidly.  The success of this initiative has depended on the buy in by top executives, or almost all of them.

Those of us working in new drug development as well as other development of associated treatments for cancer welcome more collaboration to help uncover needed information about cancer and   potential  treatment solutions. Back in 2001 a CEO Roundtable on Cancer was formed to address a challenge from then President George H.W. Bush to address cancer prevention, diagnosis, and treatment within their families as well as within their corporate family.  See http://www.businesswire.com/news/home/20140408005149/en/CEO-Roundtable-Cancer-Launches-Project-Data-Sphere

After dealing with recognized legal, privacy and technology issues in making the sharing of patient data from commercial as well as nonprofits  possible, the Life Science Consortium an offshoot of the not-for profit  CEO Roundtable on Cancer launched  Project Data Sphere LLC: https://www.projectdatasphere.org. “The goal is to improve the design and efficiency of clinical trials by developing new disease models and improving the understanding of patient risk factors and how comparator arms behave,” according to Erin McCallister, Senior Editor, BioCentury in the article “Unlocking Cancer Data” in their April 14, issue. Access to this information will help researchers design improved trial protocols and move innovation faster and with possibly lower cost by cutting on the waste.

The Project Data Sphere Initiative from Project Data Sphere Initiative on Vimeo.

The website will provide independent  researchers  as well as those affiliated with companies, hospitals and institutions free access to de-identified, patient-level data from the comparator arms of Phase III cancer trials sourced by academia and industry. The website currently includes nine data sets covering 3,500 patients provided by AstraZeneca plc, Bayer AG, Celgene Corp, the Janssen Research and Development LLC unit of J&J, Pfizer Inc., Sanofi and Memorial Sloan-Kettering Cancer Center. An additional 25 data sets are anticipated to be added soon.

The CEO Roundtable includes chief executives from 30 companies, cancer non-profits and cancer research centers of which, unfortunately, Genentech/Roche is noticeably absent. I was disappointed that this high profile cancer company with huge profit from oncology products is not participating. See list of Roundtable members at http://www.ceoroundtableoncancer.org/member.  The above-mentioned BioCentury article notes that Roche and Genentech have opted out of participation.

Reposted from Audrey Erbes’ blog: Audrey’s Network

Audrey’s Network includes Bay Area bioscience professionals from all sectors who are working in broad array of functions in the industry. The group originated, first, with members sourced from Audrey’s UC Extension intensive courses in Bioscience Business and Marketing (now numbering over former 1,250 students), the Syntex Syva Alumni Association, the Bio2Device Group (now has over 1,000 members) and other industry professional groups and individuals with whom Audrey has worked. The mission is to assist industry professionals continue to keep up-to-date in their fields through “sharpening the saw” regularly and building and maintaining a vibrant network.