Monthly Archives: April 2011

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If the institute’s policy is permanently rescinded, the result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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Niceness, Helpfulness & Ethics: Feedback edition

The Canadian Health Libraries Association/Association des bibliothèques de la santé du Canada has a mentorship interest group. While I can be skeptical about institutional “leadership training” and am in that awkward adolescent phase of my career in which I’m not exactly new anymore but not quite senior enough to be a mentor, the idea of being connected with an experienced Canadian health librarian seemed low-risk and potentially positive, so I signed up. Turns out that it’s actually been quite nice to be sent profession-related conversation topics on a monthly basis, and it’s been quite enjoyable to get to know my assigned mentor better (someone I might not have really connected strongly with otherwise, but with whom I have a surprising amount in common).

This month’s “check in” from the mentorship interest group is about “Compliments and criticism,” and refers readers to the recent Harvard Business Review blog post: “Don’t Be Nice; Be Helpful.” The jist of the article is that withholding constructive criticism may be “nice,” but it’s certainly not helpful to your colleagues.

I’ve written about “the dreaded librarian niceness” here before, and the email conversation with my CHLA/ABSC mentor brought up some points regarding criticism and niceness that I thought were worth copying to this blog.

There are two experiences, both of which I feel very fortunate to have had, strongly inform my approach to feedback giving/getting. The first is my classical music training, and the second is anti-racism organizing.

Classical Music Studies

The couple years before I trained in conservatory, when I was a high school student taking music lessons, I had an amazing music teacher who paired me with another student for double lessons. Not only did this give us extra lesson time, and create a bond between the two of us (who were necessarily also competitors at auditions all the time), but he taught us how to teach by having us constantly give constructive feedback to each other. I remember him early on telling us to think of 3 things the other person did well in the piece she just played, and then 3 suggestions you have to make it better. He modelled this type of feedback, and I still use this style with regularity.

What does this mean in practice? I try always to give positive feedback in at least as large a quantity as the negative, and to always lead with the positive, whether it’s giving feedback on a colleague’s grant proposal draft or student term paper comments. I don’t mean being disingenuous about how great something is; in my experience there are always some positive elements in any performance if you just look for them – and retaining the good parts is as important as improving the weak parts. When I went to conservatory and was exposed to the big bad world of the classical music industry, in which cutting, negative comments were depressingly the norm (one adjudicator’s comments on my first recital were, in totality, “The Beethoven was better [then the preceding piece], but still not good.” !!) I gained a deeper appreciation for the “civilized” and constructive way I had been taught to provide critique.

Anti-oppression Activism

Later on, I became very involved with anti-racism organizing, something I carry on to this day in various ways. This was yet another forum in which criticism could be very nasty. There are a lot of people dealing with a lot of hurt and anger and also guilt when you’re talking about societal structures of privilege and oppression.

As a person with white-skin privilege, it was really important for me to learn to self-criticize in a humane way (productively, not merely berating myself for past wrongs) and to learn to accept anger and negativity from people of colour about things I could not “fix.” Trying to be a white ally to people of colour in various contexts sometimes means hearing awful things, or being excluded for very good reasons that might nonetheless hurt my ego.

Learning to listen to people’s criticism, and even anger, toward me and the groups to which I belong, without immediately reacting, was a big thing for me. Even if I think the accusations hurled at me are unfair, I owe it to a member of a group I oppress (even if just by default, by being a member of a more privileged group) to really listen to what they say. And then consider later how I might respond.

This means suppressing the urge to immediately defend myself or my family or my school/work/co-op/etc., and the desire to “fight back.” Because the accusations weren’t really what I wanted to be fighting. Even if they were based in a misunderstanding or incorrect rumour, there was something important in them that could teach me about oppression and how to untangle it.

This is harder to explain, and to quantify, than the “3 positive + 3 negative comments” rule, but also really important and influential with regard to how I handle criticism. Even if a critique feels like an unfair attack, I try to listen to it and figure out what it’s really about, and what in the criticism is useful for my learning.

In my Current Work

I should note that both of these lessons about criticism are lessons I try to pass along in my classroom when I am teaching. At my current librarian-job workplace, the research team with which I am primarily affiliated works hard to create a constructive environment in which to workshop each other’s work. It’s not perfect – I think most of us are still a bit too hesitant to throw really rough ideas out there, which is likely a side-effect of the hierarchical structure of supervision (i.e. not wanting to look dumb in front of your boss), and a challenge of the interdisciplinary nature of the team (i.e. those from other disciplines might not understand my half-formed idea). But we do also have a fair bit of informal collegial workshopping and feedback as well – we edit each other’s papers all the time, for example.

The interdisciplinary nature of the team really highlights the different approaches to criticism. Economists, for example, can apparently be very nasty in criticism (not our economists, but ours are renegade economists who swap war stories of econ conference presentations)! In my experience, librarians (especially public librarians) tend toward being overly “nice,” but niceness is not the same as respecting a person’s rights and behaving in a just and equitable manner.

In a conversation with another blogger, Katie, here a few years ago, I wrote, “Nice is culturally based and thus culturally biased. Nice to me means exclusive to others who don’t share our cultural norms. Nice to my colleague means not challenging her when she says something racist in a meeting. Sometimes being ethical means having to be not-nice to people.” This still pretty much sums up  my problem with “the dreaded librarian niceness” and hits on some of our disciplinary challenges with constructive criticism.

-Greyson

recent Harvard Business Review blog post: “Don’t Be Nice; Be Helpful

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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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Community-Led Service Planning

As managers within library systems, we have the opportunity to be involved in the development of strategic objectives – and hence – the actions needed by staff to complete these objectives.  Service planning is an important part of this process.  As you have probably read from previous postings (e.g. see posting) there are various techniques which  can be applied ‘on the ground’ to actively engage with community – in order to ensure that the services developed by public libraries truly reflect the needs of community, and not just staff perception of community based information needs.

So, how can a library system involve community in the development of regional plans?  This is a good question, and there is no ‘one’ answer, since each library system will develop plans differently.  However, there are some steps which will be important to consider if you want to ensure your library system is developing programs and services with community.

As library staff begin to work with the newly targeted community, it is beneficial to create a plan which is multiphased – so community input and involvement can continuously have impacts.  Predetermined outputs, outcomes, and impacts, which are based on library management perceptions at the beginning of a service planning process – implies library led, not community led.  Each of these steps are part of the service planning process.  They include:

Segment

Determine which community you are writing a service plan for (e.g., Immigrants, Older Adults, People with Varying abilities, Teens etc.).  You can’t write an effective service plan for the entire community.

Determine Baseline

Internally – What resources/strengths/relationships does the library currently have to work with targeted community (e.g. – existing knowledge of community (gathering locations inside the library system or in the community, cultural norms, etc…), relationships with individuals from the community, collections, other existing services …

Externally – Who are the key individuals or organizations which should be contacted, in order to begin building external relationships with the targeted community?  Remember, the intent of community led services is not to have organizational representatives or community spokespersons identify community need; however, they can provide a wealth of information which will guide the service planning process – and provide the library with access to individual community members.  As relationships are built, start to document what you are hearing from the community (what is their perception of need, asset, role for the library etc.)

Analyze – Analyze what you/staff are hearing from the community and go back to the targeted community and verify… is what we are hearing correct?  Start exploring or at a minimum, thinking about potential service responses.

Build Staff Capacity

If a library system is going to work closely with a targeted community, it is essential that library staff are given the opportunity to know about the targeted community (what has been learned to this point from relationships which have been built) and community led approaches.  If branch or public service staff who will be working with the community are not provided with upfront training, it highly increases the danger of failure. 

Systemic Change / Branch Based Change

Build in mechanisms which allow for community involvement in impacting the development of program and service responses either across the system or in a specific community/library branch.  Many times a change in one branch can be expanded to have a regional impact.  If the change only occurs in one branch, community members will be disappointed if they visit another branch which has not implemented the change….

I am sure there are more steps to this process.. at this point in the morning.. and off the top of my head, this is a great start for library systems.  I hope this posting made sense??

P.S. This can also be applied in university library settings – where I would say librarians need to step up and assist universities in justifying the relevance of university education, not just to students and faculty, but to the greater community which subsidies these institutions.  The earlier we start doing this, and the more relevant universities are to their local communities, the more public taxpayer support they will receive!!

Finally… two new publications in Public Libraries on Community Led work.  Well, actually one new publication, and one old publication republished for an American audience.

~Ken

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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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