Considering the increasing evidence on the "adverse consequences" of lack of transparency, this piece of news is very discouraging and unfortunate. In the recent issues of BMJ, there were reports of a case in Germany which clearly demonstrated the potential dangers "lack of transparency" could have. The German institute for quality and efficiency in health care (IQWiG) did a report on the effectiveness of reboxetine but was not able to give a clear conclusion due to high risk of publication bias (for a number of studies adequate data were not published). Pfizer later provided most of the missing data and the institute did a subsequent assessment and demonstrated that reboxetine had no benefit. The published evidence overestimated the benefit of the drug.
This and other examples demonstrate the clear need for more transparency of clinical trial information. International registration and public disclosure of results of clinical trials as defined by the removed policy would be an important step towards this goal. Therefore, it is very unfortunate that an institution that has been leading in increasing transparency like CIHR has taken a step back and withdraws the policy. The whole issue including comments on this article has been in detail described and discussed in an interesting blog called social justice librarian http://sjlibrarian.wordpress.com/2011/04/22/bmj-article-about-the-cihr-t....
(1) Godlee F, Loder E. Missing clinical trial data: setting the record straight.BMJ. 2010 Oct 12;341:c5641.
(2) Wieseler B, McGauran N, Kaiser T. Finding studies on reboxetine: a tale of hide and seek. BMJ. 2010 Oct 12;341:c4942.
(3) David Moher and Alan Bernstein. Registering CIHR-funded randomized controlled trials: a global public good. Can. Med. Assoc. J., Sep 2004; 171: 750 - 751.
(4) Krleza-Jeric K. International Dialogue on the Public Reporting Of Clinical Trial Outcome and Results - PROCTOR Meeting. Croat Med J. 2008 April; 49(2): 267-268.
(These are my personal opinions and not necessarily the opinion of my employer. I am not responsible for the content in the external links)
Rapid Response:
"Adverse consequences" of lack of transparency
This and other examples demonstrate the clear need for more transparency of clinical trial information. International registration and public disclosure of results of clinical trials as defined by the removed policy would be an important step towards this goal. Therefore, it is very unfortunate that an institution that has been leading in increasing transparency like CIHR has taken a step back and withdraws the policy. The whole issue including comments on this article has been in detail described and discussed in an interesting blog called social justice librarian http://sjlibrarian.wordpress.com/2011/04/22/bmj-article-about-the-cihr-t....
(1) Godlee F, Loder E. Missing clinical trial data: setting the record straight.BMJ. 2010 Oct 12;341:c5641.
(2) Wieseler B, McGauran N, Kaiser T. Finding studies on reboxetine: a tale of hide and seek. BMJ. 2010 Oct 12;341:c4942.
(3) David Moher and Alan Bernstein. Registering CIHR-funded randomized controlled trials: a global public good. Can. Med. Assoc. J., Sep 2004; 171: 750 - 751.
(4) Krleza-Jeric K. International Dialogue on the Public Reporting Of Clinical Trial Outcome and Results - PROCTOR Meeting. Croat Med J. 2008 April; 49(2): 267-268.
(These are my personal opinions and not necessarily the opinion of my employer. I am not responsible for the content in the external links)
Competing interests: No competing interests