A case for 'open source' clinical trial data (locked behind a pay wall)

It's a major bugaboo in life sciences R&D: Biopharma researchers waste lots of time and resources doing experiments that have already been done, in part because scientists in one lab aren't sharing results with their counterparts in another lab. Now Australian researchers argue that open source rules for clinical trials could nix the replication and stymied progress which result from keeping data from studies under wraps.

(Ironically, the group from the University of New South Wales made their case in a Science Translational Medicine commentary that is locked behind a pay wall.)

Amid many calls for open access to scientific research data, the researchers say that "open sharing" of clinical trial evidence from studies could speed progress and enable trial data to be used in real-world applications, according to University of New South Wales' press release. In their commentary, they point out that the open-source movement in the software sector advanced the development of applications by making source code freely available.

To realize their vision for open sharing of clinical data, the Australian researchers call for letting clinicians contribute to and tap a pool of interoperable patient-level data, creating data standards for sharing the data, and open the airwaves of communication between doctors and developers, Life Scientist reported. Yet whether the clinical community can overcome the economic and cultural barriers that hackers cleared to drive the open source software movement remains an open question.

"Similar roadblocks plague the clinical evidence domain where, despite a rapid increase in the volume of published research, physicians still make decisions without access to the synthesized evidence they need," said Dr. Adam Dunn, who co-authored the commentary and serves as a UNSW Australian Institute of Health Innovation Research Fellow.

Recently, however, there have been some signs that scientific and clinical data could become more widely available. The Wellcome Trust recently endorsed an initiative to make all scientific research available for free and the U.K. charity plans to start a new open-access journal for publishing studies. And the FDA's IT chief, Eric Perakslis, has said he would push for open source projects to make non-proprietary data at the agency accessible to researchers.

- here's the release
- see Life Scientist's article
- and the Science Translational Medicine commentary abstract (sub. req.)

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