Big pharma on big data collaboration

Last week alone, no fewer than three different models emerged for sharing big data across the pharmaceutical industry.
By Dillan Yogendra
07:13 AM

The overwhelmingly positive vote (547 to 17) is also aimed at clinical trial data transparency but only targets new trials commencing after the law takes effect. Assuming it is enacted, the benefits of a legislative model will be:

  • Requirement that all drug trials in Europe are registered before they begin on the publicly accessible EU clinical trials register.
  • Requirement that a summary of the results from these trials is published on the register within a year of trial end.
  • Requirement that a summary understandable to a lay person of what was found in the trial is published on the register.
  • Establishment of a new publicly accessible EU clinical trials register, to be set up and run by the European Medicines Agency.
  • Imposed financial penalties on anyone running a clinical trial that does not adhere to these new laws.

The other approaches announced include the 5-year commercial agreement between Genentech and PatientsLikeMe that also targets cancer research as the lead effort. The data in this case are not clinical trial data but data provided by actual patients in the course of their current treatment for a wide-range of conditions including cancer.

Also, Project Data Sphere (PDS) was announced with the official opening of an online resource to share clinical trial data for use in cancer research.

The number of available datasets available today is fairly small (currently nine), but the list of companies committed to providing data is impressive and includes AstraZeneca, Bayer, Celgene, Janssen R&D, Pfizer, Memorial Sloan Kettering Cancer Center and Sanofi.

The primary objective is to accelerate drug discovery and development. Formal registration for professional researchers will be required, but there will be no charge for accessing the research, uploading datasets and access will be available online globally.

“Using clinical trial datasets collaboratively is a big leap forward in the cancer drug discovery process. 8.2 million people still die of cancer every year while the attrition rate for clinical testing of promising compounds can be as high as 95%. This could become substantially lower once researchers in both academia and industry share clinical trial data. We’re excited to be working with world class partners like SAS, SAGE Bionetworks, academia, many in industry and importantly patient groups to bring this free resource to researchers globally,” said Charles Hugh-Jones, Chief Medical Officer for North America, Sanofi.

Also in development are datasets to be provided to PDS by the Alliance for Clinical Trials in Oncology (sponsored by the National Cancer Institute), Amgen and Quintiles.

The flurry of data collaboration has taken years to develop, but it also speaks volumes about the need to accelerate drug discovery and development globally.

The larger question then seems to be whether the value of a voluntary ‘open-source’ model will outweigh the regulated or commercial variants. In all cases, however, the clear intent is for patients to benefit directly from accelerated drug development and the use of their de-identified data for broader research purposes. Clinical trial data that is captured and used once is time consuming, expensive and often at risk of being duplicated.

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