September 1, 2005

To: The Research and Research Administrators' Communities

Subject: Registration of randomized controlled trials (RCTs) funded by CIHR

As you may know, CIHR is registering all RCTs that it funds with the ISRCTN-Current Controlled Trials registry (ISRCTN-CCT) at http://www.controlled-trials.com/isrctn ¹.

We are writing to request that all CIHR funded principal investigators be advised to also register their ongoing randomized controlled trials (RCTs), with the http://www.clinicaltrials.gov registry by September 13, 2005. We are concerned that our grantees may not be aware that currently, they must also register with http://www.clinicaltrials.gov, in order to maintain access to publication in top medical journals.

In their June 2005 statement², thirteen members of the ICMJE³ request trial registration as a prerequisite for publishing, and they accept only registries that are publicly owned.

CIHR is highly supportive of that historical decision by the editors, but disagrees with the exclusion of the IRSCTN-CCT registry, as does the British Medical Journal, BMJ⁴. CIHR will continue to register trials that it funds with the IRSCTN-CCT.

With the aim of improving the quality of trials and their reporting, CIHR began international trial registration in 2004⁵. CIHR selected the IRSCTN-CCT registry, as it was found to be superior to other registries, including ClinicalTrials.gov, for the following reasons:

1. Use of a unique trial identifier (ISRCTN);
2. Non-drug trials could be registered (the majority of randomized controlled trials funded by CIHR are of this type);
3. Standards for completion of the various data fields were higher, and could be controlled by CIHR. We felt that better quality information was more important than the issue of public vs. private ownership.

CIHR is highly supportive of trial registration, and has been participating in this global initiative in various ways, by registering the RCTs it funds, and by actively participating in the dialogue of the Ottawa Group⁶ and the WHO initiative⁷.

We find it unfortunate that our researchers are now in the situation of having to register their trials again in another registry. Hopefully this is only a temporary situation, as under the auspices of the WHO, we are moving to global registration standards which include the accreditation of registries. The ISRCTN-CCT registry is in the process of transferring to public ownership, and so will presumably become acceptable to journal editors.

Considering that the ClinicalTrials.gov registry does not have any validation of data entry, please advise your PIs, to make sure that their entries are meaningful. They might find the data prepared for the CIHR RCT Summary Form useful and time saving.

If you have any questions or require further clarifications, please contact Dr. Karmela Krleza-Jeric at (613) 957-6130, email kkrleza-jeric@cihr-irsc.gc.ca, or contact me.

Mark A. Bisby, M.A., D.Phil.
Vice-President
Research Portfolio

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¹ ISRCTN-International Standard Randomized Controlled Number.

² DeAngelis CD, Drazen JM, Frizelle A. Et al. Is this clinical trial fully registered? A statement from the International Committee of medical journal editors, CMAJ, 2005;172 (13).

³ ICMJE- International Committee of Medical Journal Editors; CMAJ is one of them. BMJ disagreed exactly on the issue of accepting the CCT.

⁴ Abbasi K, Godlee F. Next steps in trial registration: Minimum criteria have been agreed, and intentions restated. BMJ. 2005;330:1159.

⁵ CIHR Joins in the International Registration of Randomised Controlled Trials

⁶ http://ottawagroup.ohri.ca

⁷ ICRTP is the International Clinical Trials Registry Platform, the WHO initiative.