Clinical Trial Registry

As a condition for publication of trial results , the International Committee of Medical Journal Editors (ICMJE) now requires all new clinical research studies that begin enrolling subjects on or after July 1, 2005 to be entered in a public registry at or before the onset of subject enrollment.

What is a clinical Trial? ICMJE defines clinical trials as: “Any research project that involves prospective assignment of human subjects to an intervention or comparison group to study the relation between a medical intervention and a health outcome. This definition includes drugs, surgical procedures, devices, behavioral treatments, and process-of-care changes. Studies that are designed for other purposes, such as to study pharmacokinetics or major toxicity studies (e.g., phase 1 trials) are exempt."

Where should a clinical trial be registered and who is responsible?ClinicalTrials.gov is a widely used public registry that meets the ICMJE criteria. The "Sponsor" of the study is responsible for registering the trial in a public registry. Institutes within NIH are the Sponsors of the trials that they are funding. The Sponsor of industry-initiated and funded multi-center studies is the pharmaceutical or device company who developed the protocol for the study. For investigator-initiated studies from our faculty, UMC is considered the Sponsor and is therefore responsible for registering those studies. The Medical Center is a registered Sponsor at Clinicaltrials.gov , and Pamela Tazik, Director of Sponsored Programs, is the designated University Administrator for UMC’s ClinicalTrials.gov account.

What is the process for registering a clinical trial? For investigator-initiated studies, the process is described below.

IRB approval of the clinical trial is a prerequisite for registration.
UMC's IRB does not review the data registered for a given trial. This review is performed by the University Administrator for UMC's ClinicalTrials.gov account.
An individual user account will need to be established at ClinicalTrials.gov by the University Administrator for the Principal Investigator (PI) of the study. Send an e-mail to ptazik@dor.umsmed.edu providing the PI's name and e-mail address. The request will be posted to ClinicalTrials.gov and the PI will receive an e-mail from ClinicalTrials.gov providing his/her login and temporary password.
The PI or the PI's designee will enter specific information about the study; this is the minimal registration data set" referenced above and given in Table 1. ICMJE will consider a registration data set inadequate if it has missing fields or fields that contain uninformative terminology."
Once the information is entered and the individual exits the site, an e-mail is sent to the University Administrator asking for a review of the information posted, to edit as necessary, and then to approve for actual viewing at ClinicalTrials.gov. This University Administrator review is an important step in avoiding inadvertent violations of any confidentiality provisions in the Clinical Trial Agreement that the PI and UMC have signed.
The PI is responsible for maintaining the accuracy of the information on the registered trial. This includes updating the information as appropriate, and noting when enrollment ceases.

Contact the Office of Research or Pam Tazik at ptazik@dor.umsmed.edu with questions about this procedure.

More information is available at: http://www.icmje.org/

http://www.icmje.org/clin_trialup.htm.

http://www.aamc.org/research/clinicaltrialsreporting/start.htm

Table 1. Minimal Registration Data Set*

Item	Comment
1. Unique trial number	The unique trial number will be established be the primary registering entity (the registry).
2. Trial registration date	The date of registration will be established by the primary registering entity.
3. Secondary IDs	May be assigned by sponsors or other interested parties (there may be none).
4. Funding source(s)	Name of the organization(s) that provided funding for the study.
5. Primary sponsor	The main entity responsible for performing the research.
6. Secondary sponsor(s)	The secondary entities, if any, responsible for performing the research.
7. Responsible contact person	Public contact person for the trial, for patients interested in participating.
8. Research contact person	Person to contact for scientific inquiries about the trial.
9. Title of the study	Brief title chosen by the research group (can be omitted if the researchers wish).
10. Official scientific title of the study	This title must include the name of the intervention, the condition being studied, and the outcome (e.g., The International Study of Digoxin and Death from Congestive Heart Failure).
11. Research ethics review	Has the study at the time of registration received appropriate ethics committee approval (yes/no)? (It is assumed that all registered trials will be approved by an ethics board before commencing.)
12. Condition	The medical condition being studied (e.g., asthma, myocardial infarction, depression).
13. Intervention(s)	A description of the study and comparison/control intervention(s) (For a drug or other product registered for public sale anywhere in the world, this is the generic name; for an unregistered drug the generic name or company serial number is acceptable). The duration of the intervention(s) must be specified.
14. Key inclusion and exclusion criteria	Key patient characteristics that determine eligibility for participation in the study.
15. Study type	Database should provide drop-down lists for selection. This would include choices for randomized vs. non-randomized, type of masking (e.g., double-blind, single-blind), type of controls (e.g., placebo, active), and group assignment, (e.g., parallel, crossover, factorial).
16. Anticipated trial start date	Estimated enrollment date of the first participant.
17. Target sample size	The total number of subjects the investigators plan to enroll before closing the trial to new participants.
18. Recruitment status	Is this information available (yes/no) (If yes, link to information).
19. Primary outcome	The primary outcome that the study was designed to evaluate. Description should include the time at which the outcome is measured (e.g., blood pressure at 12 months)
20. Key secondary outcomes	The secondary outcomes specified in the protocol. Description should include time of measurement (e.g., creatinine clearance at 6 months).

*The data fields were specified at a meeting convened by the WHO in April 2004; the explanatory comments are largely from the ICMJE.