Withdrawal of clinical trials policy by Canadian research institute is a “lost opportunity for increased transparency”BMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d2570 (Published 21 April 2011) Cite this as: BMJ 2011;342:d2570
All rapid responses
The Canadian Institute for Health Research's (CIHR) decision to
withdraw its policy on clinical trial registration and results
transparency months after posting it on its website represents a major
step back from the global leading position that CIHR took in December
2010.1 This step backwards is the most distressing one, considering the
fact that the World thirsts for total transparency in clinical
I hope that Canada - for the sake of worldwide transparency in clinical
research - reconsiders its actions, reinstalls the policy, and again takes
the leading role in the fight for transparency in clinical research.
1. Silversides A. Withdrawal of clinical trials policy by Canadian
research institute is a "lost opportunity for increased transparency". BMJ
2. Gotzsche PC, Jorgensen AW. Opening up data at the European
Medicines Agency. BMJ 2011; 342:d2686.
3. Wilmshurst P. The regulation of medical devices. BMJ 2011;
Competing interests: Member of The Ottawa Group working for transparency in clinical research.Coordinating Editor of The Cochrane Hepato-Biliary Group.Danish Coordinator in ECRIN (European Clinical Research Infrastructures Network).Patient.
Like other patients, I wish my treatment choices to be informed by as
high a proportion as possible of relevant research evidence. Now, after
showing exceptional leadership in promoting changes that will serve my
interests as a patient, the Canadian Institute of Health Research has
decided that it is more important to protect commercial interests than to
protect the interests of patients.
I urge the CIHR leadership to reconsider this shameful change of
policy and restore the organisation's formerly excellent public image.
Competing interests: I am a patient who wishes to be assured that all relevant research evidence can be taken into account when choices have to be made about my treatment.
It is disappointing that CIHR appears to be going backwards by
replacing its constructive and helpful policy with a less specific one.
The previous policy encouraged full trial registration and proper results
disclosure -- surely things that any funder should seek to promote.
The harms caused by publication bias and selective reporting have
been well documented* but these problems can be avoided by prospective
registration of all trials and full disclosure of their findings. While
journal editors (especially the ICMJE) have been instrumental in ensuring
trial registration is adopted, there is little they can do about non-publication. It is therefore vital that funders, and other influential
bodies, put pressure on researchers to ensure results are properly
reported otherwise the medical evidence base will continue to be
*one study of CIHR funded research showed that 59% of outcomes
relating to adverse effects of treatments were incompletely reported --
see Chan et al CMAJ 2004;171:735-40
Competing interests: I served as a member of the WHO Scientific Advisory Group on trial registration and received expenses for attending meetings and payment for consultancy on this project.
The German Institute for Quality and Efficiency in Health Care
(IQWiG) is an independent scientific institute that investigates the
benefits and harms of medical interventions and conveys the results of its
research to decision makers in the German health care system as well as to
patients and physicians (www.iqwig.de). Publication bias has been a major
problem in our work [1, 2]. IQWiG has therefore repeatedly called for
compulsory trial registration and results disclosure [3-5].
The decision by the Canadian Institute for Health Research (CIHR) to
abandon its exemplary policy on trial registration and results disclosure
and adopt the far more lenient requirements of the Tri-Council Policy
Statement (TCPS-2) is in our view a major setback for transparency in
As already pointed out by other researchers responding to this decision,
stringent regulations on trial registration and results disclosure are
effective tools to minimize publication bias. Their implementation is thus
a prerequisite for unbiased evidence-based decision-making in health care.
If one considers the damage hitherto caused by publication bias [4,
6], particularly by the non-reporting of adverse effects [7-9] (not to
mention the waste of resources and misguidance of future research), the
CIHR's decision seems all the more regrettable.
1. Eyding, D., et al., Reboxetine for acute treatment of major
depression: systematic review and meta-analysis of published and
unpublished placebo and selective serotonin reuptake inhibitor controlled
trials. BMJ, 2010. 341: p. c4737.
2. Institute for Quality and Efficiency in Health Care. Rapid-acting
insulin analogues in diabetes mellitus type 1: Superiority not proven.
2007; Available from: https://www.iqwig.de/rapid-acting-insulin-analogues-
3. Wieseler, B., N. McGauran, and T. Kaiser, Finding studies on
reboxetine: a tale of hide and seek. BMJ, 2010. 341: p. c4942.
4. McGauran, N., et al., Reporting bias in medical research: a
narrative review. Trials, 2010. 11(1): p. 37.
5. Institute for Quality and Efficiency in Health Care. IQWiG: Law
must prescribe obligation to publish all clinical trials. 2010; Available
6. Song, F., et al., Dissemination and publication of research
findings: an updated review of related biases. Health Technol Assess,
2010. 14(8): p. 1-220.
7. Moore, T.J., Deadly medicine: why tens of thousands of heart
patients died in America's worst drug disaster 1995, New York: Simon &
8. McCormack, J.P. and R. Rangno, Digging for data from the COX-2
trials. CMAJ, 2002. 166(13): p. 1649-50.
9. Dyer, O., GlaxoSmithKline faces US lawsuit over concealment of
trial results. BMJ, 2004. 328(7453): p. 1395.
Competing interests: Non-financial competing interests: We require full access to clinical trial data for the production of unbiased reports and support mandatory trial registration and results disclosure.
It is somewhat ironic that the decision to retract the Canadian
Institute for Health Research (CIHR) clinical trials transparency policy
in favour of less robust requirements under the Tri-Council policy
statement, Ethical Conduct for Research Involving Humans (TCPS-2) should
be shrouded in such mystery. Sadly, interest values inherent in
transparency initiatives often dictate 'degrees of opacity', rather than
transparency, which could otherwise be comprehensive. For that reason, the
implication that the Canadian research-based pharmaceutical industry has
recently been in discussion with CIHR to 'improve' the clinical trial
environment translates as facilitating the unbridled activity of the
pharmaceutical industry at the expense of public health, is all too
One cannot help but conclude that the discussions which took place
behind closed doors between the CIHR and research-based industry have
emerged with weaker clinical trial disclosure, incoherent regulatory
oversight and a nasty taste in the mouth. Details of the discussions in
respect to transparency and clinical trials should be made public and a
full explanation of the timing should be demanded from CIHR, because as
the article points out, it doesn't currently make sense.
In the current financial climate, relationships between commercial
and public interests are likely to become ever more apparent. Transparency
is an essential way of ensuring good practice. The CIHR have missed a
golden opportunity to show the way, but have sadly now reinforced the view
that transparency is fast becoming a tradable currency in the relationship
between commerce and health.
Competing interests: No competing interests
According to a recent BMJ article on CIHR's decision to "disappear"
its policy on clinical trial registration, "Ian Graham, CIHR's vice
president Knowledge Translation and Public Outreach, stated the CIHR
policy was removed 'as the overlap [with Tri-Council Policy Statement:
Ethical Conduct for Research Involving Humans (TCPS 2)] will cause
confusion and inconsistent application of the requirements.'" 
Ironically, this explanation is itself confusing and inconsistent
with previous decisions made by CIHR. There are at least three areas in
which CIHR policy/guidelines overlapped with TCPS 2 (registration and
results disclosure of trials, research involving Aboriginal People, and
research involving human pluripotent stem cells), and in each case CIHR
took a different approach.
First, as regards registration and results disclosure of trials, CIHR
declared that TCPS 2 "supersedes" the "Policy on registration and results
disclosure of controlled and uncontrolled trials funded by CIHR" and
removed the policy from its website. 
Second, as regards research involving Aboriginal People, CIHR
declared that "the CIHR Guidelines for Health Research Involving
Aboriginal People are no longer CIHR funding policy. Health research
involving First Nations, Inuit and Metis people in Canada is henceforth
governed by the provisions outlined in Chapter 9 of the Tri-Council Policy
Statement: Ethical Conduct for Research Involving Humans (TCPS)." At
first glance, this might appear consistent with the approach taken with
respect to registration and results disclosure, but there are important
differences. CIHR has not removed these guidelines from its website.
Moreover, the Introduction to Chapter Nine of TCPS 2, states that "[t]he
CIHR Guidelines remain an important source of additional guidance for
health research involving Aboriginal peoples in Canada."
Third, as regards research involving human pluripotent stem cells,
CIHR elected to retain the "Guidelines for Human Pluripotent Stem Cell
Research" (originally drafted by CIHR in 2002 and since then endorsed and
periodically updated by the three federal funding councils). In line
with this decision, TCPS 2 states that "Researchers who intend to conduct
research to derive or use pluripotent stem cells shall follow the
Guidelines for Human Pluripotent Stem Cell Research, as amended from time
to time and published by the Canadian Institutes of Health Research."
If anything is going to cause "confusion and inconsistent
application", it is the inconsistent (and, we would argue, ethically
indefensible) ways in which these CIHR policy/guidelines have been treated
in relation to TCPS 2.
 Milton, J Paradise Lost, ii. Line 996.
 BMJ 2011;342:d2570
 http://www.cihr-irsc.gc.ca/e/42831.html accessed May 3, 2011
 http://www.cihr-irsc.gc.ca/e/29134.html accessed May 3, 2011
page 106 accessed May 3, 2011
 http://www.cihr-irsc.gc.ca/e/42071.html accessed May 3, 2011
page 179 accessed May 3, 2011
Competing interests: Francoise Baylis - former member of the CIHR Governing Council and current member of the CIHR Institute of Gender and Health.Jocelyn Downie -- none declared
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