This document summarizes global initiatives to increase open access to clinical trial data. It discusses several key events and studies from 2000-2013 that highlighted issues of incomplete or suppressed trial results. Regulatory agencies like the EMA and FDA have since taken steps to increase reactive and proactive publication of trial data. However, pharmaceutical companies have argued against full data sharing due to concerns about misleading analyses, commercial confidentiality, and costs. Patient and advocacy groups are campaigning for all trial results to be reported. Regulators are now seeking public comments on policies to improve access to clinical trial data.

1. GLOBAL INITIATIVES TO
OPEN ACCESS TO
CLINICAL TRIAL DATA
Peter Doshi
July 26, 2013

3. Spitzer v. GSK Consent Order
August 26, 2004
Nissen and Wolski
May 2007 (e-pub)

4. “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 In particular, the unpublished data show that by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

5. 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.

6. 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

7. Reactive release of documents
The 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 data
The 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.

8. 8545 pages
8000
7000
6000
5000
4000
3000
2000
1000
One full clinical study report
(Roche Tamiflu study WP16263)
Same trial – 7 pages
in a medical journal

10. 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

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

12. Publication and access to
clinical-trial data
June 24, 2013
http://www.ema.europa.eu/docs/en_GB/docu
ment_library/Other/2013/06/WC500144730.p
df
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.”
Deadlineforcomments:Sep30
2013

13. “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”

14. The New York Times
June 30, 2013 p.B1
July 5, 2013 p.A18

15. http://www.guardian.co.uk/business/2013/jul/21/big-pharma-secret-drugs-trials
“Our engagement in the
„ALLTrials campaign‟ indicates
also our unequivocal
commitment to disclosure and
transparency.”

16. What can you do?
Take action!

17. http://www.AllTrials.net/

18. http://tinyurl.com/fda-rfc
http://tinyurl.com/ema-rfc
US and European Regulatory policies on
access to data are open for comment