FAQs About Clinical Trials Registration

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FAQs on Clinical Trials Registration

Why have clinical trial registries developed?
Allegations of selective publication and biased reporting of clinical trials have led to the demand for full disclosure and transparency. Clinical trial registries are one way to provide this transparency.

I'm a DFHCC investigator, do I register with my home institution, MGH, BWH
or Faulkner Hospital?
Yes, register with your home institution and list DFHCC as a collaborator.

Is there a single registry?
NO.
Not only are many registries being developed - three different types of registries are being promoted:
1. Registry of the results from clinical trials (databases)
2. Registry of all clinical trials that are enrolling subjects
3. Registry that includes both of the above.

What is a registry of clinical trial results?
Also called a clinical trial results database, this is a listing of completed studies with a description of the protocol and aggregate results. Currently there are several databases developed and maintained by industry. You may want to peruse the PhRMA site at: http://www.clinicalstudyresults.org/.

What is a registry of ongoing clinical trials?
This is a registry of ongoing trials that are still enrolling subjects. The information posted includes:
a. The protocol with description of trial procedures
b. Inclusion and exclusion criteria
c. Where the trial is being conducted and whom to contact for information regarding enrollment

This type of registration is being championed by a number of organizations such as the AMA, the World Health Organization, and the International Council of Medical Journal Editors (ICMJE). The registry developed and maintained by the National Library of Medicine at NIH is the most commonly used such registry and can be accessed at ClinicalTrials.gov

Do you have to register your clinical trials?
a. If your trial is a phase 3 or 4 trial with a prospectively assigned concurrent control or comparison group - REGISTER.

b. Regardless of phase, if your trial has a historical control group, or no control or comparison group – YOU DO NOT HAVE TO REGISTER

c. If your trial is a phase 1 (toxicity or pharmacokinetics) – YOU DO NOT HAVE TO REGISTER

d. If your trial is a phase 2 – or uncertain phase – and it has a prospectively assigned concurrent control or comparison group, you have three choices:
     --Register for ‘just in case’
     --Do not register if you have a sound rationale to support your decision
     --Contact the specific journal* and ask for guidance

*ICMJE signatories:
New England Journal of Medicine, Journal of the American Medical Association, Annals of Internal Medicine, The Lancet, The Medical Journal of Australia, The New Zealand Medical Journal, Norwegian Medical Journal, Canadian Medical Association Journal, Croation Medical Journal, Dutch Journal of Medicine, Journal of the Danish Medical Association.

Who is responsible for completing the registration?
a. The principle investigator is responsible for completing registration.
b. For industry-sponsored trials: contact the sponsor to determine registration responsibilities.
c. For clinical trials that that may be submitted to an ICMJE journal – register with ClinicalTrials.gov. Instructions on how to submit information can be found at: http://prsinfo.clinicaltrials.gov.

I just received an email from ClinicalTrials.gov informing me that my record is “In Progress”. What does “in progress” mean to me?
NIH identifies the progress of clinical trials registration in stages. “In Progress”, means that you are creating (or modifying) the record.

I just received an email from ClinicalTrials.gov informing me that my record is “Completed”. What does “completed” mean to me?
NIH identifies the progress of clinical trials registration in stages. “Completed” means you have finished entering the data for this study and the record is now
ready for our review.

I just received an email from ClinicalTrials.gov informing me that my record is “Approved”. What does “approved” mean to me?
NIH identifies the progress of clinical trials registration in stages. “Approved” means the Institutional Administrator has reviewed the record and has made
any necessary changes.

I just received an email from ClinicalTrials.gov informing me that my record is “Released”. What does “released” mean to me?
NIH identifies the progress of clinical trials registration in stages. “Released” means the Institutional Administrator has released the record to ClinicalTrials.gov.

Who is the sponsor?
a. If your study was initiated and funded by a pharmaceutical or device company, the company is the sponsor. Check with them about registration.
b. If your study is funded by the federal government and you are the grantee, the granting agency is the sponsor. Send us the grant number and title and we will work with ClinicalTrials.gov to get you registered through the granting agency.
c. If the study is funded (or not) in any other way, your “home hospital/institution” is considered the “sponsor”.

Who is the “Oversight Authority”?
a. If your study involves a drug, biologic or device, the oversight authority should be listed as: United States: Food and Drug Administration.
b. If your study does not fall under the FDA’s purview, the oversight authority should be listed as: United States: Institutional Review Board.

What about collaborators?
In order to list collaborators, they must be “recognized” by ClinicalTrials.gov. This means that CT.gov must have confirmation from the collaborator that you are working together. Therefore, you may enter the name of the collaborator. You will be prompted to submit information about the collaborator. CT.gov receives your request and contacts the collaborator. Once CT.gov has confirmed with the collaborator that it is okay to list him/her as a collaborator, the registration can be completed. NOTE: you are not required to list collaborators.

What is the NIH Public Policy Access?
“The Policy requests that beginning May 2, 2005, NIH-funded investigators submit to the National Library of Medicine’s PubMedCentral (PMC) an electronic version of the author’s final manuscript, upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH.”

Is this policy the same as the requirement for registering clinical trials?
NO.
These are two separate and unrelated requirements.

Which types of NIH funding are covered by this policy?
The Policy applies to: “all research grant and career development award mechanisms, cooperative agreements, contracts, and institutional and individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies.”

When must you submit your manuscript?
Immediately to 12 months after final publication – although, the NIH encourages submission as soon as possible.

How do you submit your manuscript?
Information can be found at http://nihms.nih.gov
This website also provides more information.