Big Pharma spends billions of dollars each year researching, developing and testing new treatments for cancer. In the meantime, it’s also collecting millions of data points that figuratively sit on a shelf and collect dust once a clinical trial is complete.
A consortium of Big Pharma companies and research organizations are attempting to give that raw data a second life by making it available to researchers on the new Project Data Sphere platform.
The not-for-profit PDS initiative was designed to be a single place where the cancer research community can share and analyze data. Specifically, it’s housing de-identified, patient-level data from late-stage comparative studies.
The idea is that expanding access to that historical clinical trial data could help other researchers better understand disease progression, accelerate drug development or design more efficient clinical trials. As the site launches today, it includes nine data sets from AstraZeneca, Bayer, Celgene, Johnson & Johnson, Pfizer, Sanofi and Memorial Sloan Kettering Cancer Center.
Charles Hugh-Jones is the vice president of medical affairs, North America for Sanofi Oncology and is also part of the CEO Roundtable on Cancer’s Life Sciences Consortium, which developed and funds the platform. He said the initiative was born out of a dire need for new ways to approach cancer research. Some 8.2 million people still die of cancer each year, and less than 10 percent of potential new drugs that enter clinical trials end up on the market.
Former President George H.W. Bush commissioned the CEO Roundtable on Cancer in 2001, challenging a group of executives from more than 30 U.S.-based organizations to work together to achieve what no one organization could do on its own in preventing, diagnosing and treating cancer. The Life Sciences Consortium came together a few years later, comprising member organizations who could work together to collaborate on R&D efforts in oncology.
“We were thinking about, what is it we can do together that no individual organization could do on its own?” Hugh-Jones said. “The real power of this is going to come from getting very large numbers of datasets and combining that with the power of the crowd.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
An additional 25 data sets will be added to the platform soon, and the eventual goal is to include data from 25,000 patients over the next year, the PDS website says.
Access is free for researchers, who need only to fill out an application and agree to the data-sharing terms on the site. They can download raw data from all of the available studies, or use a suite of analytics tools built into the platform through a partnership with SAS Institute Inc.
The new platform comes at a time when several Big Pharma companies have recently pledged to become more transparent with clinical trial data. PDS says it addresses prior obstacles to clinical trial data sharing by working with legal and privacy experts, clinicians, commercial institutions and patient groups to build the framework.
Once it gets more data sets, PDS will launch two more pillars of the platform. The first will be a series of research challenges to spark new discoveries in certain therapeutic areas, starting with prostate cancer, Hugh-Jones said. Then, it will add a social media layer that will provide different resources for researchers to use to collaborate on projects virtually.
“Our idea is that if we included the data, the study protocols, case report forms and data descriptors and put that in an environment with free data analytics, you could do some really amazing things,” Hugh-Jones said.
