September 7, 2005

Dear Colleagues:

On July 16, 2005 my predecessor, Dr. Michael Klag, sent you an email alerting you to a new policy developed by the International Committee on Medical Journal Editors (ICMJE) concerning publication of clinical trials. The ICMJE have agreed to only publish clinical trial reports if the study has been registered on a database that is electronically searchable to the public at no charge, open to all registrants, not for profit, and has a mechanism to ensure the validity of the registration data. Clinicaltrials.gov is one of the sites where registration of trials can be completed. Each trial only has to be registered once so anyone involved in a multicenter clinical trial needs to discuss responsibility for registration with their colleagues.

It is important to note that ongoing trials need to be registered by September 13, 2005 and it may take a few days for the process to be completed. Clinical trials starting now need to complete registration before the enrollment of the first patient.

For more details important links include: http://www.insidehopkinsmedicine.org/news/leadershipcorner/2005/071605.cfm http://www.icmje.org/clin_trialup.htm
http://prsinfo.clinical trials.gov

I hope you find this information helpful.

Sincerely,
Daniel E. Ford, M.D., M.P.H.
Vice Dean for Clinical Investigation