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Registration of Clinical Trials on ClinicalTrials.gov

May 2016

The Johns Hopkins Medicine (JHM) “Organization Policy on Registration of Clinical Trials” (Policy No. 103.25) required investigators/sponsors to register clinical trials on http://www.clinicaltrials.gov.  The site is electronically searchable, accessible to the public at no and maintained by the National Library of Medicine.  Under the JHM policy, a clinical trial is defined as, "any research study that prospectively assigns human participants or groups of humans to one or more health related interventions to evaluate the effects on health outcomes."  Health outcomes include any biomedical or health-related measures, including pharmacokinetic measures and adverse events. 

Listed below are the answers to questions you should be asking in regards to ClinicalTrial.gov registration

Why Register Clinical Trials?

  • Commitment to research participants
  • Scientific Integrity
  • Ethical standards
  • Responsible stewardship of federal funds
  • Required by Law (FDAAA)
  • Required by NCI
  • Required for Journal Publication (ICMJE)
  • Required for CMS
  • Required by WHO

Who is Responsible for Registering a Trial?

The Responsible Party (RP) for a clinical trial must register the trial and submit results information. An RP can be:

The Sponsor of the clinical trial (as defined in section 21 CFR 50.3) who initiates the study.  The Johns Hopkins PI should consult with commercial sponsors to assure that posting of a trial is in accord with terms of the study contract.

The Principal Investigator (PI) of such clinical trial, assuming:

  • the PI is responsible for conducting the trial,
  • has access to and control over the data from the clinical trial,
  • has the right to publish the results of the trial, and
  • has the ability to meet all of FDAAA's requirements for the submission of clinical trial information.

The Sponsor-Investigator (the individual who both initiates and conducts the study)

For clinical trials being conducted in the Sidney Kimmel Comprehensive Cancer Center, the Oncology Clinical Research Office (CRO) is responsible for clinicaltrials.gov user account set-up. Contact the CRO at 410-955-0350 for registration information.

What Trials Should be Registered on ClinicalTrials.gov?

As of January 25, 2008, the following new or ongoing trials* need to be registered on http://www.clinicaltrials.gov:

“Applicable Clinical Trials (ACT)” include the following:

  • Trials of Drugs/Biologics:  Controlled, clinical investigations of a product subject to FDA regulations.  This includes preliminary studies or phase I trials to be published in an ICMJE journal.
  • Trials of Devices:  Controlled trials with health outcomes, other than small feasibility studies, and pediatric post-market surveillance.
  • The trial has one or more sites in the U.S.
  • The trial is conducted under an FDA Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) application
  • The trial involves a drug, biologic, or device that is manufactured in the U.S. or its territories and is exported for research
    •  More data elements are required than under prior federal law, and these new requirements include:
      • Primary and secondary outcome measures;
      • Start date;
      • Target number of subjects; and
      • Adverse events.

Trials that are excluded:

  • (Non-serious/life-threatening) Phase 1 drug trials, including studies in which drugs are used as research tools to explore biological phenomena or disease processes
  • Small clinical trials to determine the feasibility of a device or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes
  • Trials that do not include drugs, biologics, or devices (e.g., behavioral interventions)
  • Non-interventional (observational) clinical research, such as cohort or case-control studies
  • Trials that were ongoing as of September 27, 2007, and reached the Completion Date before December 26, 2007
  • For trials that are already registered, these new data fields as well as the previous data fields must be updated when there are changes to the study.

(*An “ongoing” trial has enrolled one or more subjects and the final subject has not been examined or received an intervention for the purpose of collecting data on the primary outcome).

ACT Wizard: http://grants.nih.gov/clinicaltrials_fdaaa/docs/Flow_chart-ACT_only.pdf

When should you register a Trial?

Clinical trial registration information should be requested concurrently with the initial IRB application.  If the trial has not been registered at that time, the PI may indicate the National Clinical Trial (NCT) number is “pending” and report the NCT number immediately after obtaining from ClinicalTrials.gov.  It is the responsibility of the Johns Hopkins PI to notify the IRB as soon as the NCT number has been obtained by submitting a change in research application. The Johns Hopkins PI will also be reminded at the time of the continuing review application to indicate the NCT number.

The Responsible Party for an Applicable Clinical Trial must submit required clinical trial information through the Protocol Registration and Reporting System (PRS) no later than 21 days after enrollment of the first participant

https://www.clinicaltrials.gov/ct2/manage-recs/fdaaa

The International Committee of Medical Journal Editors (ICMJE) requires, as a condition of consideration for publication, registration in a public trials registry. Trials must register at or before the onset of patient enrollment. This policy applies to any clinical trial starting enrollment after July 1, 2005.

http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/

The RP should be aware that ClininicalTrial.gov must review all registrations prior to making them viewable to the public.  The review process usually takes 2-5 business days and may result in comments that must be reviewed and responded to.  Your trial has not been fully registered until you receive an e-mail from ClininicalTrial.gov indicating your trial record has been approved and providing your NCT number.

The format for the ClinicalTrials.gov registry number is “NCT” followed by an 8-digit number, e.g.: NCT00000419.

What are the obligations of the Johns Hopkins PI regarding registration if the trial is commercially sponsored?

  1. Consult with the commercial sponsor to ensure that posting the clinical trial on the government website is in accord with the terms of the study contract.
     
  2. Report the NCT # of the commercially-sponsored trial on the IRB application

What are the requirements for updating clinical trial registrations?

  1. Unless there have been no changes, registration information must be updated no less than once every 6 months.
     
  2. If recruitment status for the study changes (ex., recruitment suspended), the registration must be updated within 30 days.
     
  3. If the trial is complete (whether concluded or terminated prior to conclusion), registration must be updated within 30 days.

What are the Requirements for posting basic study results?

Final results are expected to be reported in a publicly accessible manner within twelve (12) months of the trial's primary completion date, regardless of whether the clinical trial was completed as planned or terminated earlier. The following items must be posted on the site:

  1. DEMOGRAPHIC AND BASELINE CHARACTERISTICS OF PATIENT SAMPLE – A table of the demographic and baseline data collected overall and for each arm of the clinical trial to describe the patients who participated in the clinical trial, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any.
     
  2. PRIMARY AND SECONDARY OUTCOMES – The primary and secondary outcome measures, as stated in FDAAA Section 801, and a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical significance of such outcome measures. 
     
  3.  POINT OF CONTACT – A point of contact for scientific information about the clinical trial results.

Detailed instructions for submission of “Basic Results” may be obtained on the clinicaltrials.gov Protocol Registration System (PRS) website at http://prsinfo.clinicaltrials.gov/fdaaa.html.

How do I Register a Clinical Trial?

To create an account contact the appropriate Johns Hopkins PRS Administrator;

For further information, please see the guidance on registration of clinical trials at ClinicalTrials.gov: How to Register Your Study at https://clinicaltrials.gov/ct2/manage-recs/how-register

Are there Penalties for Failure to Register a Clinical Trial?

There are now penalties for responsible parties who fail to register applicable clinical trials or who submit false or misleading information.  Civil monetary penalties are allowed under FDA regulations. Civil penalties for investigator sponsors can range up to $10,000/day (see, Food and Drug Administration Amendments Act of 2007 (FDAAA Law)).  For federally-funded trials, the penalties could include withholding or recovery of grant funds.

Contact Information

Feel free to contact the PRS Administrators listed above for any questions you may have about accounts, registration, updating and reporting on ClinicalTrials.gov.  

Common Associated Acronyms

  • Applicable Clinical Trials (ACT)
  • Food and Drug Administration Amendments Act of 2007 (FDAAA)
  • Food and Drug Administration (FDA)
  • International Committee of Medical Journal Editors (ICMJE)
  • Investigational Device Exemption (IDE) application
  • Investigational New Drug Application (IND)
  • Johns Hopkins Medicine (JHM)
  • National Clinical Trial (NCT) number
  • Principal Investigator (PI)
  • Protocol Registration System (PRS)
  • Responsible Party (RP)

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