GLOBAL INITIATIVES TO OPEN ACCESS TO CLINICAL TRIAL DATAPeter Doshi

July 26, 2013

Spitzer v. GSK Consent OrderAugust 26, 2004

Nissen and WolskiMay 2007 (e-pub)

“As described on the FDA Web site, the published CLASS trial differs from the original protocol in primary outcomes, statistical analysis, trial duration, and conclusions. In particular, the unpublished data show that by week 65, celecoxib was associated with a similar number of ulcer complications as diclofenac and ibuprofen.”

Hrachovec JB, Mora M. JAMA. 2001;286(19):2398-2400.

2000-2001

Doshi P, Dickersin K, Healy D, Vedula SS, Jefferson T. Restoring invisible and abandoned trials: a call for people to publish the findings. BMJ. 2013 Jun 13;346:f2865.

John Castellani is the President & Chief Executive Officer of the Pharmaceutical Research and Manufacturers of America (PhRMA).

Ben Goldacre is a best-selling author, broadcaster, campaigner, medical doctor and academic

Reactive release of documentsThe Agency has been releasing documents [>1.9 million pages so far] submitted as part of applications for marketing authorisation on request since November 2010 … including clinical-trial reports, once the decision-making process for the medicine in question has been completed.

Proactive publication of dataThe Agency has committed to the proactive publication of the data from clinical trials supporting the authorisation of medicines. This will enable the independent re-analysis of the evidence used by the Agency's committees to determine their benefits and risks and is expected to lead to public-health benefits.

8545 pages80007000600050004000300020001000

One full clinical study report(Roche Tamiflu study WP16263)

Same trial – 7 pages in a medical journal

Arguments against sharing data• Industry

• Misleading analyses• Commercial confidential information• Patient privacy/confidentiality• Too much work• Not everybody needs so much detail

• Academics• Too much work• No money• Unclear how to share• Promotion/career

http://www.ema.europa.eu/

Publication and access toclinical-trial dataJune 24, 2013 http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/06/WC500144730.pdf

16 pages

“The Agency respects and will not divulge commercially confidential data or information. In general, however, CT data cannot be considered CCI; the interests of public health outweigh considerations of CCI.”

“Access to CT data … will make drug development more efficient … learn from past successes and failures … develop new knowledge in the interest of public health … promote better-informed use of medicines … enable third parties to verify the regulatory authority’s positions and challenge them where appropriate.”D

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“The contribution of patients who participate in clinical trials should be maximized for the benefit of society.”

“We note that this proposal contemplates the availability of certain data after appropriate steps have been taken to de-identify it and remove the data's link to a specific product, study, or application. This proposal does not pertain to unmasked safety and effectiveness data, (i.e., data that can be linked to a specific, identified application) including full study reports”

The New York TimesJune 30, 2013 p.B1July 5, 2013 p.A18

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ls “Our engagement in the ‘ALLTrials campaign’ indicates also our unequivocal commitment to disclosure and transparency.”

What can you do?

Take action!

http://www.AllTrials.net/

http://tinyurl.com/fda-rfc

http://tinyurl.com/ema-rfc

US and European Regulatory policies on access to data are open for comment