July 16, 2005

Dear Colleagues:

I am writing to alert you to a requirement applicable to clinical trials, and the implications for faculty who wish to publish clinical trial results. The International Committee on Medical Journal Editors (ICMJE) has implemented a policy that requires registration of new clinical trials as a condition of publication. Details about the policy may be found on line at: http://www.icmje.org/clin_trialup.htm. The ICMJE does not require clinical trial registration on a particular website. Instead, they have stated requirements for an acceptable registry. The registry must be: electronically searchable and accessible to the public at no charge; open to all registrants and not for profit; and, have a mechanism to ensure the validity of the registration data. Many trials are being listed on the ClinicalTrials.gov website through the Protocol Registration System at http://prsinfo.clinicaltrials.gov.

The ClinicalTrials.gov website was initially developed to allow sponsors of multi-center trials to post information on approved research and to allow the public to access information about such research. Many studies conducted at JHMI are already listed on this site because the sponsors of many multi-center clinical trials have registered the trials and listed all study sites. The ICMJE policy extends the obligation to register a trial to any individual conducting a clinical trial who wishes to have results of the trial published. The policy took effect on July 1, 2005. The BSPH is centralizing the registration process for clinical trials, and the Cancer Center will coordinate the process for oncology faculty. After consideration of the number of trials conducted at the SOM, we have decided that investigators, other than oncology faculty, will have the responsibility for determining; 1) whether or not a trial for which they are the investigator/sponsor should be registered and, 2) completing the registration. To register on the ClinicalTrials.gov website, you will need to establish an individual account. Johns Hopkins Medical Institutions should be listed as the organization name. The website directs you through the steps required to register. Registration is required once, but information must be updated on a regular basis. Please take time to review the ICMJE policy and registry websites. It is in your best interest to make sure that your trials are registered with an acceptable trial registry.

Thanks.

Sincerely,

Michael J. Klag, M.D., M.P.H.
Vice Dean for Clinical Investigation