Cautious Moves Toward Data Transparency by Big Pharma

PhRMA Data Sharing Proposal

A longtime goal of some researchers has been to obtain public access to clinical trial data for approved drugs and medical devices. Access by competent investigators was requested first, but patient groups have also sought access to such data.

The key offering is to disclose
. . . patient-level clinical trial data, study-level clinical trial data,and protocols from clinical trials in patients for medicines and indications approved in the United States (US) and the European Union (EU) as necessary for conducting legitimate research.
The proposal also recommends that:
  • negative as well as positive findings should be published 
  • external reviewers as well as each company's review process will be publicly disclosed 

Greater transparency for clinical trial data may be forthcoming if such an industry plan gains traction. It will take more than just providing an email address and getting a password. The proposal would require that companies set up "outside panels." and such panels would review data sharing requests from “qualified” researchers. Data recipients would also have to explain how the data was to be used.

Skeptical advocates such as Ben Goldacre of AllTrials.com, quoted by The Scientist, said  “the industry commitments suggested here are weak and filled with loopholes. . . They fall way short of the concrete commitments the European Medicines Agency has already made about sharing trial information, and also fall short of recent commitments from GSK and Roche.”

Some theorize that this effort is mainly to ward off European Union regulators, as reported by New York Times writer Katie Thomas. The announcement was made by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations. The original sharing proposal text is available at their web site.

KNOWLENGR Knowledge Engineering Analysis 

From the manufacturers' perspective, there are some serious concerns. Apart from the patient privacy concerns, risk of frivolous requests and competitive issues, it is a new information technology initiative that will require sophistication and protocols -- especially if indirect consumer access is anticipated. Because standards for interoperable data sharing across publishers is still evolving, compliance with the proposal will entail more than posting up a public Google spreadsheet. As work at the Elsevier Innovation Explorer community has shown, there are various stakeholders with different perspectives on what constitutes data quality, transparency and usability. For instance, how can there be a data warehouse of information across manufacturers if there is no agreement that could represent a de facto master data management plan?

Gartner defines MDM as “a technology-enabled discipline in which business and IT work together to ensure the uniformity, accuracy, stewardship, semantic consistency and accountability of the enterprise’s official shared master data assets.”

It will be awhile before "transparency" can be added to this definition for public clinical trial data warehouses.

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