Project assignment Building a website through HTML
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ClinicalTrialsPresentation02.20.2019Tgibbs1.pptClinicalTrials.gov: An Introduction
Presented by: Tawana Gibbs, MA, CRS
CT.gov Administrator
Date: February 20, 2019
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Important Terms to Know
ACT- Applicable Clinical Trial
ICMJE- International Committee of Medical Journal Editors
CMS- Center for Medicare and Medicaid Services
NIH- National Institute of Health
FDAMA- Food and Drug Administration Modernization Act of 1997
FDAAA- Food and Drug Administration Amendments Act of 2007
HHS- Department of Health and Human Services
FDA- Food and Drug Administration
NCT- National Clinical Trial
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What is ClinicalTrials.gov?
Web-based resource that provides patients, their family members, healthcare professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.
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https://clinicaltrials.gov/ct2/about-site/background#WhatIsClinicalTrials
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- 1997: Congress Passes Law (FDAMA) Requiring Trial Registration
- 2000: NIH Releases ClinicalTrials.gov Web Site
- 2005: International Committee of Medical Journal Editors Requires Trial Registration
- 2006: World Health Organization Establishes Trial Registration Policy
- 2007: Congress Passes Law (FDAAA) Expanding ClinicalTrials.gov Submission Requirements
- 2015: CMS requires NCT # for all billable research claims
- 2016: Final Rule for FDAAA 801 Issued
- 2016: Final NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information Issued
- 2017: Final rule implementing major revisions to the Common Rule
https://clinicaltrials.gov/ct2/about-site/history
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CT.gov: Historical Timeline
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Registry and Results Database Purpose
Registry purpose:
Fulfill ethical obligations to participants and the research community
Provide information to potential participants and referring clinicians
Reduce publication bias
Help editors and others understand the context of study result
Promote more efficient allocation of research funds
Helps institutional review boards (IRBs) determine the appropriateness of a research study
Results Database Purpose:
Provide a public record of basic study results in a standardized format
Promote the fulfillment of ethical obligations to participants and the overall contribution of research results to medical knowledge
Reduce publication and outcome reporting biases
Facilitate systematic reviews and other analyses of the research literature
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Why Registration is Required
It is the law.
Your ability to publish could be affected.
Your funding as an investigator and for the institution could be affected.
Civil monetary penalties up to $10,000 for all violations in a single proceeding.
$10,000/day after 30 day period that the violation is uncorrected.
HHS may withhold remaining or future grants funds
NIH may post public notices of non-compliance and issue penalties.
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Agencies that Require Registration
- FDA
- NIH
- ICMJE
- CMS
Note: All 4 agencies have the ability to affect funding and publication for noncompliance.
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ClinicalTrials.gov Registration Timeframe for Agencies
- FDA/NIH- study is required to be registered no later than 21 days after 1st subject is enrolled
- CMS/ICMJE- study must be registered prior to first subject being enrolled
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Is My Study an Applicable Clinical Trial
- Generally:
- Study type: Interventional
- Study Phase/Primary Purpose: Other than Phase 1/other than feasibility
- Studies a U.S. FDA-regulated drug/device product
- One or more of the following
- At least one facility location with the U.S./U.S. territory
- Clinical trial has an IND or IDE
- A drug/device product under investigation is a product manufactured and exported from the U.S
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Decision Tree for NIH Clinical Trial Definition
NO
YES
NO
NO
NO
YES
YES
YES
Does the study involve human participant research?
Are participants prospectively assigned to an intervention?
Is the study designed to evaluate the effect of the intervention on the participants?
Is the effect being evaluated a health-related biomedical or behavioral outcome?
This study is a clinical trial.
The study is NOT a clinical trial.
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If UAMS is Lead site:
Clinical Trials.gov administrator in ORRA will notate determination in CLARA
Notify PI of the determination and create new record once IRB approval is obtained.
Administrator will work with PI to have record approved by CT.gov, who will then provide the NCT number.
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Study is an Applicable Clinical Trial
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CT.gov Administrator and
PI Responsibilities
CT.gov Administrator Responsibilities:
Review for possible registration
Create and maintain Ct.gov record
Provide a notification for Ct.gov update to PI, as needed
Assistance with CT.gov conference call
Principal Investigator Responsibilities:
Input all clinical trial information in appropriate section of modules
Update information when changes have been made or at the request of the administrator
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FYI: The CT.gov administrator is notified when changes have been made to the record
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CT.gov Database Modules
- Protocol Section
Study Status
Oversight
Study Description
Study Design
Outcome Measures
- Results
Participant Flow
Baseline Characteristics
Outcome Measures and Statistical Analysis
Adverse Events
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Tips on ClinicalTrials.gov
- Know your study
- Acronyms and misspellings
- Outcome measures
Primary outcome must be single, specific, and have a measurable outcome
- Use the modules for detail, leave detail out everywhere else
- No verbs and pronouns
- Make it easy on yourself copy/paste where you can
- Ask for help!
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What’s New: Clinical trials.gov
https://clinicaltrials.gov/ct2/about-site/new
INFORMATION ON REGISTERING CLINICAL TRIALS:
http://prsinfo.clinicaltrials.gov
Revised FAQ section
https://clinicaltrials.gov/ct2/manage-recs/faq#act
The International Committee of Medical Journal Editors policy on trial registration:
http://www.icmje.org/clin_trialup.htm
NIH Policy on the Dissemination of Clinical Trial Information
http:// grants.nih.gov/grants/guide/notice-files/NOT-OD-16-149.html
History of Clinicaltrials.
https:// clinicaltrials.gov/ct2/about-site/history
Source: Zarin DA, Keselman A. Registering a clinical trial in ClinicalTrials.gov. Chest. 2007;131(3):909-12. [Full Text]
Source: Tse T, Williams RJ, Zarin DA. Reporting "basic results" in ClinicalTrials.gov. Chest. 2009;136(1):295-303. [Full Text]
RESOURCES
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Contact Information
Tawana Gibbs,
UAMS ClinicalTrials.gov Administrator
Office of Research Regulatory Affairs
Slot 813
Phone: 501-686-5190
Email: [email protected]
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