Category Archives: Health

Update on withdrawn CIHR trials policy

In an only somewhat-overdue update (thanks to conference season interrupting my regular blogging activities – I do write on the road, but need to get sleep & give a read over before I can push “publish” on a post) the Canadian Instutites of Health Research (kind of the Canadian NIH, for US American readers) has put out a new message regarding the missing CIHR trials policy that we’ve been following since late March.

To backtrack a bit, while I was on the road and having fun with research and colleagues over the past month, there was more coverage of the CIHR trials policy disappearance, including Michael Geist’s blog and the National Post. Additionally, “rapid response” letters from around the world continued to roll in to the BMJ related to their article, some with great titles such as, “Canadians step back from the well of transparency while the World is thirsting for it” and “CIHR decides it must compromise my interests as a patient.”

Then, right around June 15 or so (I saw it on the 17th), CIHR President Dr. Alain Beaudet issued a “Message from the President – Policy on ethical conduct of research involving humans.” Go read it: http://www.cihr-irsc.gc.ca/e/43756.html. If you’re anything like me, you may need to read it a few times over, because it’s not the clearest statement ever made.

Here’s what I think it’s saying:

  1. That the March removal of the trials policy (“Registration and Results Disclosure of Controlled and Uncontrolled Trials”) was about “harmonization” and deference to the TCPS-2
  2. The TCPS-2 has some requirements for trial registration and public disclosure
  3. While the trials disclosure requirements in the TCPS-2 and the former CIHR trials registration policy were in the same spirit, the CIHR policy had more specific directions about what needed to be done
  4. CIHR will (at some unspecified point) be  integrating certain of these more stringent operational requirements as part of the terms and conditions of its “relevant programs.” These include: a) publication of the systematic review used to justify the trial, b) registration and compliance with WHO requirements for minimum data disclosure, and c) submission of final reports in CONSORT format.
  5. CIHR will propose 4 revisions to the TCPS-2 for “prompt consideration” (not clear on how soon this can/will happen): a) applying to all trials, not just clinical trials, b) requirement to update trial registration when the trial protocol changes, c) requiring that serious adverse events be reported in post-trial publications, and d) and a requirement to deposit aggregate data in an unbiased, publicly accessible database.
  6. In the interim, CIHR will specify that researchers have to “comply with all the requirements mentioned above” (not sure whether this means 4a-c or is also inclusive of 5a-d).

So, what does this mean? Are we all good now?

Well, we’re better than we were before the press coverage, I think. We’re not as better as we would have been, had the trials policy never been pulled.

Remaining questions:

  1. Really??? I’m still kind of skeptical that 3 months after the trials policy and the TCPS-2 came out, both of which had been in development for a looong time, someone suddenly just went, “Oh, gosh, you know what? It’s not okay to have both of these policy statements!” Why am I skeptical? Well, because it just doesn’t make sense. CIHR had a trials policy that wasn’t 100% the same as the TCPS-1. Tri-council funders have all sorts of different policies that are more stringent than the TCPS, and it’s not a problem (e.g., the beloved CIHR Access to Research Outputs policy). It’s just not adding up, and at this point the message seems to be that it doesn’t matter if it’s not adding up, CIHR is sticking to their story.
  2. When will the CIHR be implementing these new requirements for relevant grant programs, and how will this implementation be different from the trial policy rules?
  3. What’s the process for revisions to the TCPS, and how long does it take?
  4. When are we going to see the requirement to make individual-level/micro/”raw” data publicly available? The item listed above in 5d, which currently has no teeth, only requires aggregate data deposit. What does this mean? How aggregate? Does this have to include all adverse events? We need to be able to reanalyse this data to look for harms to specific groups. This is one of the most important parts of the scrapped trials policy, and there is no mention of it in the new statement from CIHR.

I think the international attention and public pressure on CIHR over the withdrawal of the new trials policy likely contributed to these developments, which seem like a step back in the right direction. However, without teeth in the current requirements, and a return of the publicly-accessibly micro-level data archivng requirement, it seems like 3 steps forward, 2 steps back at this point.

-Greyson

Previous posts on this topic, in case you haven’t been following along:

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BMJ article about the CIHR trials policy disappearance

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
industry.”

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.”

-Greyson

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Details: TCPS-2 vs the CIHR trials policy of 2010

Thanks to a few days’ time and some help from people with more experience reading science policy, I now feel that I can expand on my previous post about the TCPS-2 “superseding” the Dec 2010 CIHR trials policy.

First of all, I note that I am putting “supersede” in quotes not merely because it is a really cool word to which I wish to draw attention (although it is) but because the TCPS-2 was officially launched before (not, as I had previously thought, simultaneously with) the new Trials Policy, and as such, would not likely have been intended as a replacement for another policy that had not yet been unveiled.

Non-exhaustive list of differences between the TCPS-2 and the CIHR trials policy of 2010:

  • Unlike the TCPS-2, the CIHR policy required that the systematic review that justifies doing the trial be publicly cited.
  • TCPS-2 is specifically about clinical trials, whereas CIHR could be interpreted to apply to a wider scope of “controlled and uncontrolled trials.”
  • The CIHR policy required following the WHO international standards, whereas the TCPS-2 only requires that trials be registeres in registries that meet the criteria of WHO/ICMJE. Seems like a small distinction, but the difference is the minimum dataset required.
  • This one is kind of nitpicking/pointing out an oversight, but the CIHR required the name of the trial registry as well as the registation #, whereas the TCPS-2 only asks for the # (kind of useless without the name, and presumably they want the name too, but didn’t specify).
  • The CIHR policy took steps to prevent duplicate/multiple registration, whereas the TCPS-2 does not address this potential issue.
  • The TCPS-2 says that “Researchers should also promptly share new information about an intervention with other researchers or clinicians administering it to participants or patients, and with the scientific community – to the extent that it may be relevant to the general public’s welfare,” which does not require public disclosure. The CIHR policy required the data to be made publicly available to all.
  • Research design amendments (changes) require ethical approval under the TCPS-2. The CIHR policy required that amendments  to the research design be reported within 30 days after the ethics approval.
  • The TCPS-2 asks for “new risks” or “unanticipated issues that have possible health or safety consequences for participants” during the trial. CIHR policy did not ask for adverse event info until after the trial.
  • TCPS-2 asks for info that might merit or lead to early stopping of  a trial. CIHR policy wanted notification and public disclosure within 30 days of stopping a trial early.
  • The TCPS-2 tells researchers “to make reasonable efforts to publicly disseminate the findings of clinical trials in a timely manner by publications and by the inclusion of raw data and results in appropriate databases,” whereas the CIHR policy specified reporting guidelines (e.g., CONSORT for RCTs) and required reporting and public disclosure within 12 months of the end of the trial, building on the existing CIHR research access policy.
  • The TCPS-2 encourages researchers and institutions to publish results in a timely manner. The CIHR policy required public disclosure within 12 months and reserved the right to disclose the final report themselves within 18 months.
  • The TCPS-2 asks for “the inclusion of raw data and results in appropriate databases” whereas the CIHR specified what appropriate databases are and that both micro (aka “raw” aka “participant level”) as well as macro (aka “aggregate” aka “summary”) level data are necessary.
  • The TCPS-2 talks about ethics with regard to confidentiality clauses and PI access to trial data, whereas these issues were not addressed by the CIHR trials policy.
  • The CIHR policy talks about after-trial follow-up, including submission of any “severe adverse events or harm” to the publicly-available trial registry and a requirement to “retain all trial information including original micro-level data and metadata data for twenty five years unless they are deposited in a freely accessible data repository (to align with the Health Canada requirements).”

Generally speaking, major differences are:

1) Insider vs public disclosure of information

TCPS-2 is concerned with sharing info with the research ethics board and “to other researchers or clinicians administering it to participants or patients, and with the scientific community.”

CIHR was concerned with reporting and disclosing info “to CIHR and the trial registry” – and the trial registry had to be openly accessible to the public.

2) Whether to specify how much should be reported, and how soon to report it

The TCPS-2 advises on ethical matters across disciplines. It makes few specific mandates as to timeliness or data specifics.

The CIHR policy was intended specifically for trials funded by CIHR, and similar to other funding policies could and did specify details of what kind of data should be reported (all, macro and micro), to whom (CIHR and a publicly accessible registry), and when (within 12 months of trial completion, or with some types of data 30 days of early stoppage of a trial).

TCPS-2  on its own vs. as part of a comprehensive approach

I’m not saying the TCPS-2 is bad. It’s pretty good, overall, and after years and years of collaboartive work and revision seems to do an admirable job of doing what it’s supposed to do – which is to set out general, interdisciplinary, national ethical guidelines, not details of practice requirements. Without specific procedural policies designed to instruct researchers in various disciplines, the TCPS-2’s appropriately limited scope leaves us with somewhat vague directions.

The two policies, the TCPS-2 and the CIHR trials policy of 2010, are clearly intended to complement with each other. As I noted before, the TCPS-2 specifically states that:

“[Trial] registries, in addition to agency policies, editorial policies, ethical policy reforms, and revised national and institutional ethics policies and results disclosure requirements, contribute to a multi-faceted approach to eliminate non-disclosure.” (emphasis mine)

I continue to be very disappointed that the CIHR has apparently seen fit to retroactively withdraw their facet of this approach, and I do think that as a public agency they do owe the public a decent explanation of what happened here. What has been made publicly available thus far does not add up. As I have stated previously, there may well be valid reasons for killing the new policy on clinical trial data, but the lack of transparency around the policy retraction continues to be troubling.

-Greyson


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Follow-up: CIHR trials transparency policy

Here is the official word from the CIHR on the clinical trials transparency policy that was so transparent that no one could see it:

According to  Dr. Ian Graham, Vice-President, Knowledge Translation, the new Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS-2) supersedes the Policy on registration and results disclosure of controlled and uncontrolled trials funded by CIHR.

The trials registration & disclosure policy page that was recently a 404 page is now a redirect page to the TCPS-2.

I find this response unsatisfying. Here’s why:

  • I don’t understand why a policy would supersede another policy announced at the same time. Both policies were in development for years, but they didn’t notice until three months after they were simultaneously unveiled that they were redundant? Seems unlikely.
  • It also seems odd that CIHR would send a KT Senior Advisor on a tour around the country educating people all about a new policy they would then suddenly decide was obsolete.
  • While I have been assured that “CIHR is committed to transparency in clinical trials,” I have not gotten a clear answer as to whether or not all the exact requirements of the apparently-obsolete CIHR policy are included in the TCPS-2. (Am working on going through it with a fine-toothed comb, but it is >200 pages long and I have a head cold, so it’s slow going. ) I am particularly concerned about the preservation & disclosure of individual-level data and reporting of all adverse events in clinical trials.
  • The TCPS-2 clearly states (Article 11.3) that “[Trial] registries, in addition to agency policies, editorial policies, ethical policy reforms, and revised national and institutional ethics policies and results disclosure requirements, contribute to a multi-faceted approach to eliminate non-disclosure.” It is concerning that CIHR apparently does not feel that the  CIHR policy facet of this “multi-faceted approach” is important.

If the TCPS-2 does ensure the same clinical trial reporting standards as the recently-retired-at-a-young-age CIHR policy, then this is possibly just an embarrassing right-hand-doesn’t-kn0w-what-left-hand-is-doing situation.

If, on the other hand (er, that would be the third hand in the middle, I guess?) the TCPS-2 is not as specific in mandate for clinical trial registration and reporting as the CIHR policy was, this is a great loss for open access, open data and public health and safety. Making detailed clinical trial data publicly available for third-party re-analysis is the best way we have to provide safeguards on drug approval, safety & effectiveness processes – processes that CMAJ rightly criticizes as opaque and secretive.

CMAJ has its own conflicts of interest, certainly, and I haven’t let them off the hook for that. But they are not the only ones. We must be vigilant not only about transparency in our scholarly publishing processes, but also about our government health agencies, including those that fund scientific research.

I would hope that CIHR’s relationship with, say, pharmaceutical companies (and their former employees), would never dictate their clinical trials policies. But I want the transparency to know that is true, for sure. And I’m certainly not getting it around this question right now.

If anyone has more info on this, I’m still looking for insight here, so please contact me.

-Greyson

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Cached Copy: Policy on registration and results disclosure of controlled and uncontrolled trials funded by CIHR

For the record.

-Greyson

This is Google’s cache of http://www.cihr-irsc.gc.ca/e/42831.html. It is a snapshot of the page as it appeared on 17 Mar 2011 22:31:42 GMT. The current page could have changed in the meantime.

Policy on registration and results disclosure of controlled and uncontrolled trials funded by CIHR

Table of Contents

  1. Preamble
  2. Policy Objective
  3. Guiding Principles
  4. Application
  5. Responsibilities of the Grantee
  6. Monitoring and adherence
  7. Policy Review

Appendix 1 – Additional information and resources


1. Preamble

CIHR‘s randomised controlled trial policy was announced in June 2004. This policy requires that all CIHR-funded randomised controlled trials (RCTs) be registered with an International Standard Randomised Controlled Trial Number (ISRCTN). The goal of the policy was to help ensure access to information about CIHR-funded RCTs.

 

Since 2004, a number of developments related to trial registration and results disclosure have occurred, including the development of International Council of Medical Journal Editors (ICMJE) and Ottawa Group statements, World Health Organization (WHO) International standards, expansion of existing registries and creation of new ones, development of the WHO network of primary registries, development of Standard Protocol Items for Randomised Trials (SPIRIT) elaborations of Consolidated Standards of Reporting Trials (CONSORT), CIHR‘s Policy on Access to Research Outputs, a dialogue on results disclosure – Public Reporting of Clinical Trials Outcomes and Results (PROCTOR), etc.

Currently prospective registration consists of submitting pre-defined controlled or uncontrolled trial protocol items to either one of the primary registries of the WHO or registry that is acceptable to the ICMJE prior to the recruitment of the first trial participant. The registry assigns an identification number (ID) and posts registered data on a freely accessible website. The assigned ID is meant to be used in all future communications including publications stemming from the given trial. Duplicate registration should be avoided.

2. Policy Objective

The objective of this Policy is to increase the transparency and accessibility of trials by improving their registration and disclosure of their results. Prospective public registration and disclosure of results are expected to help reduce publication bias, and fulfill ethical responsibilities to share knowledge gained from trials. It also complies with the WHO International standards, ICMJE requirements, and Declaration of Helsinki, thereby contributing to global initiatives to increase accountability of publicly funded health research.

3. Guiding Principles

In accordance with CIHR‘s commitment to the highest scientific and ethical standards and core values the following principles guide CIHR in promoting openness and transparency of all trials through prospective registration and reporting of results.

  • Trial participants, the general public, decision makers, clinicians, public and private funders and sponsors, have a right to access the full information about ongoing and completed trials.
  • Trial registration and results disclosure will enhance their openness and transparency which will in turn ensure accountability
  • Prospective registration and disclosure of results of trials will contribute to the advancement of science, innovation, and strengthening of public trust in controlled and uncontrolled trials
  • Academic freedom and the right to publish will be enhanced by prospective registration and disclosure trial results

These principles are aligned with international standards for trial registration developed by the WHO and endorsed by ICMJE and with principles defined by the Ottawa Statement.

4. Application

This policy supersedes the 2004 policy on registration of randomized controlled trials (RCTs) and it will come into effect for all competitions with application deadlines after December 31, 2010.

While Researchers awarded grants prior to this date are only obliged to adhere to the 2004 policy, they will be encouraged to adhere to the requirements of this policy.

5. Responsibilities of the Grantee

5.1 Prospective Registration of Trials

Grantees are required to:

  1. register all CIHR funded trials following the 2006 WHO international standards prior to the recruitment of the first study participant by providing at least the WHO Trial Registration Data Set, ethics approval (one per country, generally for the main site), a reference to the systematic review that justifies the need for proposed trial, and other trial details, to any WHO/ICMJE endorsed registry.
  2. register the trial in only one WHO primary registry or registry acceptable to ICMJE (such as ClinicalTrials.gov) following the WHO international standards for prospective trial registration. In instances when trial is registered in more than one registry, the grantee must provide cross-references to each registry including the identification number.
  3. provide CIHR with the name of registry and the identification number issued by the registry. This ID should be used in all further communication with CIHR, publications, presentations, and on the trial website if it exists.

5.2 Public disclosure of trial information during trial

Grantees are required to:

  1. update trial information in the registry at least once a year, usually following annual ethics review and re-approval.
  2. report to CIHR and the registry major changes to the protocol such as the change of a primary or secondary outcome, or any other protocol amendment that requires ethics approval, upon approval by the ethics board, within 30 days.
  3. report to CIHR and the trial registry early stopping or termination of a trial, within 30 days.

5.3 Public reporting (disclosure) of trial results

Grantees are required to:

  1. submit, for RCTs, the CONSORT -based final report to CIHR within 12 months after the end of the trial, its early stopping, or termination regardless of the reason. CIHR considers this report public and has the right to publicly disclose it within 18 months of its submission. The grantee must follow the most recent CONSORT that corresponds to a design of his/her trial. For all other trials, the grantee must follow CIHR reporting guidelines.
  2. comply with the CIHR Policy on Access to Research Outputs by publishing trial results in an open access journal or archive peer reviewed manuscripts in an open access repository (such as PubMed Central Canada).
  3. submit trial results to a publicly accessible results databank such as ClinicalTrials.gov by completing all required fields (tables) within 18 months after the end of the trial.
  4. post the aggregate (summary) data and micro (participant) level data on an unbiased freely accessible website.
  5. report any severe adverse event or harm in the publication of the trial results following the CONSORT for harms.
  6. submit any severe adverse event or harm to the trial registry along with the results if appropriate fields exist in the registry.

5.4 Data retention

Grantees are required to:

  1. retain all trial information including original micro-level data and metadata data for twenty five years unless they are deposited in a freely accessible data repository (to align with the Health Canada requirements).

6. Monitoring and adherence

Grantees are reminded that by accepting CIHR funds they have accepted the terms and conditions of the grant or award as set out in the Agency’s policies and guidelines. In the event of alleged breach of CIHR funding policy, CIHR may take steps outlined in the Tri-Agency (CIHR, NSERC & SSHRC) Process for Addressing Allegations of Non-Compliance with Tri-Agency Policies to deal with the allegation.

7. Policy Review

As the area of trial registration and results disclosure is constantly developing and as there are no international standards for results disclosure and no acceptable trial data bank, CIHR will review and update this policy every two years or as needed.

Appendix 1 – Additional information and resources

Chan AW, Krleza-Jeric K, Schmid I, Altman DG. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ 2004 September 28;171(7):735-40.

DeAngelis C, Drazen JM, Frizelle FA, Haud C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med. 2004;351:1250-1.

DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB. International Committee of Medical Journal Editors. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. JAMA 2005;293(23):2927-9.

EQUATOR network

FDAAA

Krleza-Jeric K, Chan AW, Dickersin K, Sim I, Grimshaw J, Gluud C. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ 2005; 330: 956-958.

Krleza-Jeric K, Lemmens T. 7th Revision of the Declaration of Helsinki: Good News for the Transparency of Clinical Trials. CMJ 2009; 50:105-10. doi:10:3325/cmj2009.50.105.

Krleza-Jeric K: Building a Global Culture of Trial Registration, (pp 59-82); in: Foote MA (ed): Clinical Trial Registries; A Practical Guide for Sponsors and Researchers of Medicinal Products. Birkhauser, Verlag, Basel, Switzerland, 2006.

Laine C, Horton R, DeAngelis CD, Drazen JM, Frizelle FA, Godlee F, Haug C, Hébert PC, Horton R, Kotzin S, Marusic A, Sahni P, Schroeder TR, Sox HC, Van Der Weyden M, Verheugt FWA. Clinical trial registration: looking back and moving ahead. Ann Intern Med 2007 147:275-277

Moher D, Bernstein A. Registering CIHR-funded randomized controlled trials: a global public good. CMAJ 2004; 171(7):750-75.

Enquiries

Please direct enquiries about this policy to Dr. Karmela Krleza-Jeric, Senior Advisor, Knowledge Translation at karmela.krleza-jeric@cihr-irsc.gc.ca.

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The mystery of the missing CIHR trials policy

Who stole the Canadian Institutes of Health Research’s trial transparency policy?

Canadian health researchers report that the policy, only four months old, went missing sometime in mid-March. The policy’s full name is Policy on the registration and results disclosure of controlled and uncontrolled trials funded by CIHR.

It was last seen in the vicinity of the CIHR/IRSC website, at http://www.cihr-irsc.gc.ca/e/42831.html. The policy is described as an expansion of a previous CIHR policy, aimed at increasing clinical trial transparency and reducing biased disclosure of trial results.

We have evidence that the policy was alive not long ago.

1) Canadian health researchers around the country have received the following announcement of this new policy via e-alerts and newsletters over the past few months:

CIHR announces new policy
Policy on the registration and results disclosure of controlled and uncontrolled trials funded by CIHR (http://www.cihr-irsc.gc.ca/e/42831.html)
In 2006 the CIHR endorsed, in principle, the World Health Organization (WHO) international standards for clinical trial registration. Consequently, CIHR has updated its policy effective 20th December 2010. The new Policy will apply to all competitions with application deadlines after 1st January 2011.
The new Policy requires researchers awarded CIHR funding to:
* Register a trial in one of the WHO primary registries or      ClinicalTrials.gov prior to participant recruitment;
* Regularly update the information during the trial;
* Report and publicly disclose trial results; and
* Retain all trial information for 25 years.

The updated Policy expands on the 2004 policy on RCT registration. This Policy complies with the WHO International standards, ICMJE requirements and the Declaration of Helsinki.The Policy will help ensure that clinicians, researchers, patients and the public have access to information about CIHR-funded trials. The aim is to increase transparency and accessibility of trials by their prospective registration and disclosure of results, thereby reducing publication bias and fulfilling ethical responsibilities.
The new Policy can be accessed via the CIHR Funding Policies web page (http://www.cihr-irsc.gc.ca/e/204.html)

2) The CIHR glossary refers to this policy (under “Results”).

3) There’s a nice archived abstract and PDF of the slides from a presentation explaining the origins, development and details of the new policy, “Towards Greater International Transparency of Clinical Trials – Short Term Efforts for Long term Benefits: CIHR Trial Policy 2010” given in February by Karmela Krleza-Jeric,MD, M.Sc., D.Sc.

But the policy hasn’t been seen in at least a week, possibly longer.

The URL to which the above sources refer as the policy document on the CIHR website is currently a 404 Error page.

At first, it might seem to be merely a website glitch. However, the policy is also missing entirely from the above mentioned CIHR Funding Policies web page, despite the fact that the other recently added policy on Gender and Sex Based Analysis is listed, and the page currently says it was last updated a week ago on March 28, 2011.

Whodunnit?

Policy wonks continue to search for the missing policy, last seen at least one week ago.

At this point, authorities can only speculate on motives for this disappearance. However, the spectre of institutional conflict of interest has been raised.  At this point, we are making an appeal to the public to please contact us with any information you may have about the policy’s disappearance.

Anyone with information on the current whereabouts of the CIHR Policy on the registration and results disclosure of controlled and uncontrolled trials is asked to please leave a comment below. We hope to see this young policy safely back at home again as soon as possible.

Thank you.

-Greyson

ETA – Cached copy of the policy text is now available here.

ETA2 – Follow up post here. And another here. Also here.

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CMAJ and openness: audacity or ignorance?

I keep trying to figure out whether the CMAJ’s recent unofficial series of articles on various types of “open” is irony-aware or just pushing forward without realising what they’re doing.

Brief background: the Canadian Medical Association Journal is THE major Canadian medical journal. They’ve been around for 100 years, and become rather prominent in the English-language medical publishing world, ranking quite well in various impact rankings. CMAJ was an early adopter of a free-to-read-online access model.

Then, in 2006 there was a kerfuffle over editorial independence, leading to mass firing/resignation of journal editors (who went on to found Open Medicine, which styles itself as more open and more ethical/transparent than CMAJ). In January 2010, CMAJ became “no longer free for all” by restricting immediate free access to a portion of the journal’s contents.

The past week or so has seen a variety of CMAJ articles on open stuff: research, news items and commentary. I’ve been looking at some of these rather incredulously, unsure of whether the inherent irony and conflicts of interest here are editorially recognized or not.

What really caught my attention was the way that an article titled “The association between a journal’s source of revenue and the drug recommendations made in the articles it publishes”  was summarized in a commentary titled “Covert pharmaceutical promotion in free medical journals” (PDF, not freely available) and in the weekly CMAJ roundup as “Free journals may be biased.” This was then picked up my major news sources such as the Globe & Mail  “Free journals often promote costly or problematic drugs, study finds” and Reuters  “Widely read free medical journals hype drugs: study.”

Yes, you read that right. An article about how a journals’ acceptance of drug ads correlated with biased drug information in said journals was spun as “free journals are junk” a year after CMAJ – which incidentally accepts a whole bunch of pharmaceutical advertising stopped being entirely free online.

In case you needed a little more conflict of interest with that irony, here’s a screenshot of the banner drug ad on the very page from which I downloaded the article:

Drug company banner ad no CMAJ article about drug advertising correlating with biased articles in medical journals

Pot, kettle?

With their recent access model shift, the CMAJ of all journals should understand that access models are not the same as business models, and that free access to medical journal content may be supported by several different revenue streams, including association membership fees, advertising revenue, grants, reprint/offprint charges, and publication fees to authors.

Drug banner ad on CMAJ commentaryHmm, a drug ad on an article talking about drug funding for medical journals.…While I wouldn’t go so far as to imply that CMAJ is an industry-mouthpiece “fake journal” like some, this recent spin of “drug industry funded/biased” into “free to read” does make me wonder what’s up. Do they not realise that they’re incriminating themselves here?

CMAJ has followed this conflation of free access with pharmaceutical sponsorship with a bunch of coverage of open data – a current semi-hot topic (rapidly being eclipsed by non-confidence votes in parliament) thanks to Steven Harper’s March 18 “Open Government” strategy announcement.

First a news item alleged that “The systemic secrecy in which Health Canada shrouds data is “outdated” and “embarrassing” in comparison with the openness of other countries” , quoting co-author of the medical journal funding study Joel Lexchin as well as open government activist David Eaves. The next day, a news item lauded US President Obama’s Open Government Initiative. Just a few days later, CMAJ published an editorial titled “Will Open Government make Canada’s health agencies more transparent?”, which rightly criticizes the “black box” of Health Canada decision making, including the drug approval process.

While I’m glad the CMAJ is championing some forms of openness including more open government information, CMAJ’s own editorial decisions/independence (latter link to PDF), funding streams and potential pro-drug-industry bias are real elephants in the room here. Are the editors aware of this?

What do you think? Boldly sidestepping the issue of one’s own conflict of interest, or not being forthright enough to acknowledge it?

-Greyson

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Open access debate at CHLA/ABSC: not about OA at all

There was a lot of activity around the topic of open access at this year’s Canadian Health Libraries Association / Association des bibliothèques de la santé du Canada Conference in Kingston, ON:

While the interest group meeting and paper presentation are probably pretty much what one might have expected from such events, the debate merits some special discussion, and I finally have a minute in which to do so. The two presenters were Dr. Udo Schüklenk & Dr. Sergio Sismondo.

The conference blurb about the event states:

Like many others in the academy, Udo and Sergio, both philosophers at Queen’s University, hold considered views on the question of the ‘open access’ versus ‘subscription’ models in academic publishing. As it turns out, they find themselves on opposite sides of the spectrum. Sergio thinks that ‘open access’ is ultimately the way to go, while Udo thinks that the ‘open access’ business model is fatally flawed. Unlike Sergio, Udo carries the baggage of a serious conflict of interest, being the paid editor of a monthly subscription based journal. The two of them have engaged in vigorous debates about the pros and cons of both models on various occasions. During our conference they will put their respective cases to the audience test. Each of them will talk for about 15 min, with a 5 min slot for a rejoinder available to both. Afterwards we will open up the debate to the floor. (emphasis mine)

The debate was lively and jovial, with this clearly not being the first time this pair had engaged in verbal sparring. Neither speaker hailed from a health or library background, and both said things that caused the audience to gasp audibly (e.g., the moment in which Udo said he couldn’t imagine why anyone would ever read the journal Social Science & Medicine!). More significantly, neither demonstrated a clear understanding of the distinction between access models and business models.

As Sergio identified from the start, Udo was intended to wear the “black hat” in the debate. Sergio made pro-OA arguments that might be considered overblown, advocating for the “OA system.” (Not sure what the “OA system” is…perhaps this is like the “gay agenda”?)

Udo, on the other hand, gamely played staunch defender of the possibly-dying print journal (and pointing to the recent JAMA article-revision kerfuffle as rationale), conflating OA with online publishing.

Both debaters tried to pin journals’ ethical transgressions on their access models. While both gentlemen were clearly experts in philosophical-ethical issues, it was evident that they were not experts in scholarly publishing, as they seemed unaware of initiatives such as LOCKSS as well as disciplinary trends in citation behaviour.

When the floor was opened up to the audience, I joined a few others in scampering up to the microphones. It was not long before Sergio had to concede that, no, OA will not change anything other than access. A moment later, Udo had to admit that not only would OA improve access, but he (the alleged anti-OA debater) archived all his publications under “green” OA.

And thus, our “OA debate” was suddenly revealed as a green OA vs gold OA debate.

I started this post claiming that the “OA Debate” at CHLA/ABSC 2010 was not about OA at all. Upon reflection, that’s not true. It was about OA, just not in the way we all expected. It was about how far we’ve come in the past decade+, that nowadays an OA debate is not about “whether OA” but rather “how OA.” Pretty awesome that “opposite ends of the spectrum” can now mean “believing in different OA futures.”

Thank you to all the OA movers & shakers who have been working on this issue since before I even knew it existed.

-Greyson

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CMAJ “No longer free for all”

I’ve been thinking about the Canadian Medical Association Journal (CMAJ)‘s decision to convert from being 100% free to read online to only partially so, come January.

Access Change

The Canadian Medical Association Journal (CMAJ) has been entirely free to read, online, since it first went digital in the mid-1990’s.

This is about to change.

Letters from the publisher and editor inform us that, beginning in January,

“Editorials, news, clinical images, abstracts and previously published articles will also remain accessible to all readers. Access to reviews, analysis, practice, commentaries, humanities and supplements will be restricted [to CMA members and journal subscribers]…although these items will become free of charge 12 months after publication.”

Funder OA Requirement Implications

Research – of key concern to any researcher holding funding from CIHR or the many other research funders who require OA to publications before a year’s embargo is up – will remain free to access. However, authors should be advised that publishing in the “Reviews” or “Analysis” sections will not meet the CIHR OA requirement – and there is no pay-for-OA option to remediate that.

Bucking the Trend?

The reason given for the CMAJ’s access change is that:

We must now adapt our business model to respond to current economic conditions and can no longer provide free access to all of our content.

I think this is interesting, given all the journals that have recently been deciding they cannot afford NOT at least offer an OA option. Is there some sort of OA “sweet spot” that is most profitable in 2009/2010? Or is CMAJ just panicking and hoping to get a bit more cash in a recession here?

I’m also curious as to why CMAJ decided to restrict access to readers, rather than charging publication fees to authors. Author-side fees seem to be the current dominant method for publishers attempting to move from subscription to free-to-read models in biomedicine. (Will this be a later phase for CMAJ, post re-institution of subscriptions, effectively making an early adopter of OA end up as also a late adopter of OA?) My guess is that CMAJ authors are generally better funded than the readers. If anyone reading this has insight in to why CMAJ decided to charge readers rather than authors, I’d love to hear it!

Institutions or individuals requiring immediate access to the entire online journal will need to purchase subscriptions unless they are CMA members. (Haven’t heard much buzz on the library wire yet as far as how this $690/yr is going to affect already-shrinking serials budgets in libraries…maybe there’s nothing to say?)

The journal is also planning to publish more frequently online, and less frequently in print, to speed up publication timetables and save on postage. Wish they could scrap the print all together, but I’m not intimately familiar with the reading habits of practicing Canadian MDs, so maybe there is a reason they haven’t done the obvious yet?

CMAJ will continue to participate in the HINARI and AGORA initiatives to bring free or low-cost access to low-income international readership. They’re also giving “media” free access, and while I am really glad CMAJ’s not planning to limit journalists to lousy “press-release journalism,” I’d be interested to know who qualifies as “accredited” media in 2010.

Effect on Journal Impact?

CMAJ is one of the only Canadian biomedical/health journals to be a serious competitor in the Impact Factor rankings (ISI Journal Citation Reports). Since 1997, it’s IF has grown from 1.6 to 7.5, placing CMAJ within the top 10 general medical journals. This stellar climb in a non-U.S.American journal has frequently (but controversially) been associated with it’s wide availability – particularly since other OA journals – such as PLoS Medicine – have made similar sharp climbs. While research articles (upon which the IF formula is based) will remain free to read, it will be interesting to see whether the journal maintains its high IF ranking or slips in the years following this change. My guess is that it would take a long time to slip, if at all, because it is now fairly widely known internationally, compared with a decade ago.

Open vs Free

A couple years ago, back in July 2007, the editors of CMAJ published a commentary congratulating the editors of Open Medicine (OM) on establishing a new journal. While this congratulatory note was interesting in light of the historic editorial schism at CMAJ that gave birth to OM, the letter itself looked nice and innocuous enough. In said letter, CMAJ wrote:

Like CMAJ, Open Medicine is an open-access journal, available free to all who wish to read it and free for all who wish to contribute to it. As open access remains disappointingly rare among general medical journals (Table 1), this is both commendable and of great significance. The birth of Open Medicine thus provides us with a valuable opportunity to remind our readers why open access to the medical literature is important and necessary.

OM’s editors responded a few days later with their own letter, which struck some as less than gracious. In it, they wrote:

Although the endorsement by CMAJ’s editors of open access medical publishing is welcome, we would like to take this opportunity to clarify several points raised in their commentary.1 First, there is an important distinction between open versus free-access publication. Open Medicine has not only adopted the principle of free access, that is, making content fully available online, but endorses the definition of open access publication drafted by the Bethesda Meeting on Open Access Publishing.2 This definition stipulates that the copyright holder grants to all users a free, irrevocable, worldwide, perpetual right of access to, and a license to copy, use, distribute, transmit and display the work publicly and to make and distribute works derived from the original work, in any digital medium for any responsible purpose, subject to proper attribution of authorship. Given that CMAJ holds copyright and charges reprint and permission fees, it is not in fact an open access journal.

It’s significant to note that these letters were written before the Suber-Harnad agreement on the terms gratis OA and libre OA to indicate free-to-read/access vs free-to-read/access/reuse/redistribute. There was more talk about what was and wasn’t “real” OA just a couple years ago. Even taking into consideration the context of the day, though, the OM response could be read as a bit snitty.

However, in light of this recent “Access change” by CMAJ, the OM letter suddenly seems more relevant, almost prescient. Another difference between gratis, free-as-in-no-money OA and libre, free-as-in-freedom OA emerges when journals highlight their ability to take their toys and go home. CMAJ is not saying they’re moving anything that is currently freely available back behind subscription barriers, and they are currently planning to make everything free to read 12 months after publiciation, BUT…we are reminded that CMAJ’s articles are CMAJ’s articles. Whereas Open Medicine’s articles are ours.

-Greyson

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Online drug advertising & the regulatory challenge

Between the (minor!) bike accident , the kid’s birthday, and being out of town for a bit, blog posting has gone a bit by the wayside the past few weeks. However, something that’s been much on my mind lately, and which I’d like to discuss here, is drug advertising online.

I’ve written various posts before about DTCA – direct to consumer advertising of prescription drugs – which is legal in limited form in Canada, and in much greater form in the US. I think prescription drug promotion of all sorts is a big social justice issue, and that DTCA is a significant and oft-overlooked consumer health info issue that librarians should have on our radar. When we talk about the Pew research on online health info seeking, social media, and “e-patients,” we cannot forget that profit-motivated companies are as interested in our patients’ online information behaviour as we are, just for very different reasons.

The Canadian “freedom of expression” lawsuit on this matter has been indefinitely adjourned, but I’ve come to wonder if perhaps debating the merits and perils of television and magazine ads may be rather passé in light of the Internet’s growing centrality as an advertising medium. Maybe CanWest was not just throwing in the towel on a lawsuit that was destined for failure (b/c the FOE argument was pretty weak), but also strategically abandoning old media. Nah, actually, I think CanWest is still pretty wedded to old media, but the rest of us aren’t. And we are the target audience for DTCA.

Now, I know some people (lots of them) still watch TV on TV, even with all this digital conversion business. But will they in a decade? Not so sure. Hulu has been such a huge success in the US, spawning constant rushes of hordes of international viewers to one proxy setup after another in order to see the latest episode of their favourite shows. It’s only a matter of time before online TV is de rigueur in any region with decent bandwidth & reliable connectivity.

The unofficial rules for online drug advertising have, to this point, basically been an extension of the TV advertising regulations. It’s debatable whether this is appropriate or not. I’ll take on whether the Internet is more like TV or more like the telephone in a separate post (soon! I promise!), but I think we can all agree that it’s not *exactly* like TV.

Many online ads, for example, require some active selection on the part of the reader/viewer, and are not necessarily as time limited as TV ads (and thus able to provide fuller information). Typical online drug ads today appear as advertisements in the margins of a website, and attempt to entice the reader into clicking them to go to a website with fuller information on whatever the condition/drug may be.

In a somewhat impressive attempt to be proactive (?), the FDA (US drug regulator) held a couple days of public hearings last month on the topic of online drug advertising. The 5-page list of speakers (pdf) was heave on pharma and health tech investors, followed by representatives of online services both general and health-specific, ranging from Google to WebMD. So that pretty much covers the people who want to advertise, and those who want the money from said advertising. Of note, there were reps of specific social marketing units within pharmaceutical companies on the docket, so Pharma is well aware of the stakes here (e.g. Sanofi-Aventis has a rep, and then the Sanofi-Aventis social media working group had a rep as well). Unfortunately, I could pick out only a very few advocacy/public interest groups, such as the Consumers Union.

To backtrack a bit, this hearing didn’t come out of nowhere, although it was not terribly well publicized.Back in April, the FDA issued warnings to some 14 pharmaceutical companies over their “misleading” online advertising. At issue was failure to fully disclose risks, and these letters focused on search engine ads (aka “sponsored links” in some search engine displays).

November’s hearings, however, were broader in scope, touching on not just search engine advertising, but also ads on websites, and – perhaps most significantly – in social media. This is excellent news, as we know that social sites are an ideal location for what I called “embedded DTCA with a social environment created to reach vulnerable and isolated populations” in my post about the “patient support” site RareShare a year ago.

So what? Where is this going? What does the Internet mean for drug advertising and patient protection?
Well, there some very interesting threads to watch as this policy story unfolds:

  1. The Internet doesn’t do super well with national borders. If laws on DTCA are different in different countries, do they have to appear differently based on site host location? IP address of the end user? How? DTCA on television has taken advantage of lack of political will to enforce existing laws to broadcast US drug ads across the Canadian border. Will the Internet do any better? (Personally, I am doubtful.)
  2. The Internet, however, does allow for end-user participation on a scale unprecedented by other media. Some people have voiced optimism regarding the potential for commenting and annotation to temper, force transparency upon, and generally “culture jam” drug advertising. Google’s SideWiki has received a lot of attention in this regard, but it remains fairly unwieldy to use and market saturation is quite low.
  3. The whole net neutrality debate applies here, and the way this debate influences our view of the Internet will influence the way we feel about things like online advertising. Is the Internet a media for entertainment or communications? Is it a utility, which should be neutral and allow for participation from all, or is it a medium for consumption? We would feel quite different about picking up the phone and hearing an ad than we do about a commercial break from a TV show.
  4. Social media can really blur the line between non-profit advocacy and for-profit promotion in a nasty way. It’s one thing to regulate what can or must be said inside a little “ad” box in the margin of a website. It’s quite another to regulate embedded personalities within a social media site, who are planted there to promote certain products. I will be quite surprised if these hearings/this process even touches on this issue, but variations on hidden advertisements are a phenomenon that’s well-known in the blogging world, maybe less recognized in some other social media fora (Facebook, where everyone is supposedly using their “real name”?)

-Greyson

p.s. During composition of this post I cheked the CBC news online, and lo and behold there was an example of DTCA right on the site. So I snapped a screenshot, of course, to stick up here. This is an example of a currently-legal “disease awareness” ad for erectile dysfunction, from the Health News page of the cbc.ca:

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