Can publishers open the data door?

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The BMJ said it will not publish research papers on drugs when clinical trial data are kept secret.  What effect will BMJ have on other medical journals, and will companies begin to take the wraps off such data?
 
Matt Bennett
Sr. VP of Communications and Public Affairs, Pharmaceutical Research and Manufacturers of America (PhRMA)

Biopharmaceutical research companies are committed to transparency through timely submission and registration of all clinical trials involving patients on the NIH's database, ClinicalTrials.gov, and to releasing the results of all clinical trials conducted in patients involving our products that are approved for marketing or that are investigational products whose development programs are discontinued.
 
PhRMA supports the benefits associated with making appropriate clinical trial information available. We are concerned about the proposed release of anonymized patient-level data which could not only lead to misinterpretation of the risks and benefits of medicines, but would deter future medical innovation.
 

Jody Charnow
Editor, Renal & Urology News

I applaud BMJ for formulating a policy against publishing research papers in which clinical trial data are withheld. All clinical trial data should be made available for analysis as long as patient confidentiality is ensured. BMJ is a respected journal, so it is possible that other medical journals will follow its lead or at least give some thought to adopting a similar policy. Unless most journals agree not to publish papers in which trial data are kept secret, the policy will not likely have a major impact on pharmaceutical companies. If they cannot publish a paper in BMJ, they may shop around for another journal.
 

Jack Angel
Executive Director, Coalition for Healthcare Communication Foundation

While we should embrace any effort medical journals take to enhance the reader experience, we would be remiss if we didn't note the level of mistrust that has developed in medicine.  Between journalists seeking exposure, government seeking deficit closure, and academics seeking purity, our proud industry has suffered.  The actions that prompted BMJ's decision have largely been corrected through policy decisions of industry and academia.
Informed academics are aware of the importance of collaboration with industry because the talents of each are different and complementary.  As a result, a middle ground will be forged that protects company ownership of its secrets while advancing scientific exchange.  It is doubtful that the BMJ action will contribute much to that outcome.
 

Glen Campbell
Executive Vice President, Elsevier

BMJ's decision is another step among many that biomedical journals are taking to adjust and improve their requirements and policies in an ongoing effort to ensure the integrity of research and the biomedical literature.
The ICMJE's rules require clinical trial registration, and all the major medical journals have committed to that. The ICMJE will likely discuss the BMJ decision and whether their requirements should change.  However, I think it more likely that individual journal editors and editorial boards will make their own decision in this regard.
 
Got a forum question or comment? Send an e-mail to marc.iskowitz@haymarketmedia.com or kevin.mccaffrey@haymarketmedia.com

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