REGISTRATION OF CLINICAL TRIALS

The International Committee of Medical Journal Editors (ICMJE) requires, as a condition of publication, that all clinical trials be entered into a public registry before enrolling the first patient. The intent is "to promote the public good by ensuring that everyone can find key information about every clinical trial whose principal aim is to shape medical decision making."

The Health Science Center has selected Clinical Trials.gov (link) to provide that vehicle. We have registered as an organization through which Health Science Center Investigators may register their clinical studies.

Responsibility for registering trials for publication consideration lies with the lead sponsor of the clinical study; consequently, most industry-sponsored studies will be registered by the sponsor. Health Science Center investigator-initiated studies and those for which the institution holds the IND or IDE that meet the criteria will need to be registered prior to study enrollment.

Registration Criteria. ICMJE guidelines establish the following criteria for clinical study registration:

• Any research project that prospectively assigns human subjects intervention and comparison groups to study the cause and effect relationship between a medical intervention and a health outcome.
• Trials with at least one prospectively assigned concurrent control comparison group.
• Any trials whose primary purpose is to affect clinical practice (Phase 3 Trials.)

Exclusions to Registration. ICMJE guidelines specifically exclude from the registration requirement studies conducted for other purposes including pharmacokinetics or major toxicity (Phase I Trials).

Registration Timeline.

• New trials, started on or after July 1, 2005 (registration required before enrollment of first patient)
• Ongoing trials, by September 13, 2005.

Steps for Registering Clinical Studies. The registration system allows users at the investigator or study coordinator level to input the registration data; however, user access is provided centrally.

• Contact Jane Youngers, Protocol Registration System (PRS) Administrator at youngers@uthscsa.edu
• Request account setup for PRS users, provide user ID that you would like the PRS to use, full user name, and email address.
• When user has received email notification of account activation, access the PRS website at http://prsinfo.clinicaltrials.gov
• Log on and change password
• Go to Main Menu, then Protocol Records, select create, and follow the prompts.
• Carefully respond to data elements requested; note that fields marked with an * are required; fields marked WHO should also be entered.

Further Information on ICMJE Initiative:

Is This Clinical Trial Fully Registered? (May 2005)

Update on Clinical Trials Registration (October 2004)

Clinical Trial Registration (September 2004)