More follow up from these previous posts about the surprise disappearance of the Policy on the registration and results disclosure of controlled and uncontrolled trials funded by CIHR.
Thursday, the British Medical Journal (BMJ) published a News article by Ann Silversides, titled: Withdrawal of clinical trials policy by Canadian research institute is a “lost opportunity for increased transparency.”
For consistency’s sake I must note my dismay that this BMJ article about open data is not freely accessible online. Open access is as open access does; journals who live in glass open access houses should be cautious about criticism, folks.
Since some readers of this blog undoubtedly lack subscription access to the BMJ, here are a few choice quotes from Silversides’ article, interspersed with my commentary:
“The CIHR [Canadian Institute for Health Research] policy
certainly was leading the drive towards increasing transparency,”
said An-Wen Chan, a scientist with the Women’s College
Research Institute in Toronto and co-author of the Ottawa
Statement on Principles and Implementation of Clinical Trial
Registration and Results Reporting
If the institute’s policy is permanently rescinded, the result
would be “a lost opportunity for a federal funding agency to
make a statement that increased transparency is important for .
. . ensuring that publicly funded research has maximal impact,”
said Dr Chan.
I don’t know Dr An-Wen Chan, but I agree entirely. The policy seemed to follow naturally along the progressive path forged by the CIHR’s 2004 RCT registration policy and 2007 research access (OA) policy.
Trudo Lemmens, of the University of Toronto law school, said
the decision to remove the policy “sends a bad message.” The
TCPS-2 requirements are more general and vague than the CIHR
policy, and it is not clear who will implement and enforce
TCPS-2, he said.
Again, I don’t know Dr. Lemmens, but I agree that the rescinding of the policy sends a “bad message.”
Silversides also reports that:
The CIHR has recently been “in discussions” with Rx&D, the
trade association for Canada’s brand name drug companies, on
renewing the CIHR/Rx&D collaborative research programme
(which funds awards, grants, and clinical trials) and finding
ways “to improve the clinical trial environment,” Rx&D
president Russell Williams stated in an email.
I suppose what is an improvement to the clinical trial environment depends on your point of view. Making clinical trials more transparent, and thus more likely to be audited, by more sets of eyes, for human safety issues, seems to be an improvement to me. But if my primary concern was the ease of bringing new technology/product from trial to market, my perspective would likely be different.
Professor Lemmens, who has published widely on transparency
and clinical trials, said that at an international level, the
pharmaceutical industry has been critical of trial registration
and requirements about having to give details of results. He
speculated that “maybe it is not pure accident” that the CIHR
policy, widely regarded as pushing for more transparency in
clinical trial reporting, has been withdrawn “when there is a
clear push (in CIHR) to promote collaborative research with
And this possibility that the timing of the trials policy’s disappearance might not be “pure accident” is exactly what we don’t want to think about when it comes to our national health research funder, with a mandate:
“To excel, according to internationally accepted standards of scientific excellence, in the creation of new knowledge and its translation into improved health for Canadians, more effective health services and products and a strengthened Canadian health care system.”