One of the main goals of a trial registry is to improve the transparency of research. Existing registries have already made an invaluable contribution to enhancing the transparency of clinical research. As new issues are identified, the public documentation associated with trial registries will continue to be refined. We thank Dr. Zarin and colleagues for their comment on our study exploring the reporting of leadership information in clinical trial registries. They highlight several issues of importance to the evolving nature of clinical trial registration documentation. We address three main points raised in their comments.

First, Zarin and colleagues point out that responsible contact person (i.e. the facility contact or central contact person in ClinicalTrials.gov) information is only displayed on the ClinicalTrials.gov site during the “not yet recruiting” and “recruiting” stages of a trial. Our study was conducted in October 2006, only one year after clinical trial registration was required by ICMJE member journals as a prerequisite for manuscript submission. (1) We used the public instructions available in 2006 from ClinicalTrials.gov(2), which stated that contact information was a required field. This documentation did not clearly indicate that the display of contact information was related to recruitment status. As well, the documentation available at the time did indicate that the research contact person (the overall study official in ClinicalTrials.gov) was required to provide specific information, such as name, degree, official role, and affiliation but not contact information. We recognize the 2008 revision to the ClinicalTrials.gov documentation that now explicitly states that contact information is shown only for locations that are “not yet recruiting” or “recruiting”. (3) We support the need for contact information to be accessible for the duration of the study’s registration to facilitate transparency and accountability.

Second, Zarin and colleagues indicate that information about the responsible contact person can include a phone number or an email address. Again we used the 2006 ClinicalTrials.gov documentation (2) that listed phone number and email as contact information in the required field. The 2008 ClinicalTrials.gov documentation (3) now clearly states that contact information can be by email or phone. We also focused on reporting of email addresses as the method of contact because email is an efficient, economic, and common means of long distance communication. Further, the registries are hosted on an electronic platform, making email a logical way to make contact in relation to a trial.

Third, we agree with Zarin and colleagues that all of the investigators at individual sites participating in a trial are not required to provide contact information. This is consistent with the approach we took in our study.

In view of the important role that trial registries perform, we support continued refinement of publicly available documentation of reporting requirements. One of the major scientific and ethical reasons for trial registration is to establish a public record of completed and ongoing trials so that all existing results can be tracked even if they are unpublished. In view of this overall goal, a policy of displaying contact information regardless of recruitment status should be considered.


Melanie Sekeres M.Sc.
Andrea Gruneir Ph.D.
Joel Lexchin MSc MD
Marleen Van Laethem MHSc
Sunila R. Kalkar MBBS MD
Wei Wu M.Sc.
An-Wen Chan MD DPhil
Paula A. Rochon MD MPH

Kunin-Lunenfeld Applied Research Unit, Baycrest,
Toronto, Ontario, Canada


References

1. DeAngelis et al., (2004). Clinical trial registration: A statement from the International Committee of Medical Journal Editors. JAMA, 292:11, 1363-1364

2. ClinicalTrials.gov registration requirements. July 2005. (Accessed March 27, 2006 from www.clinicaltrials.gov. No longer available)

3. Data Element Definitions (DRAFT) February 2008, http://prsinfo.clinicaltr... accessed May 30, 2008