Transcript Clinical Trials Registry

Compliance & Quality Seminar Series
Presents:
Clinical Trials Registry
Susan Koenig, MPP&PA
Director, Office of Compliance & Quality
University of Missouri-Columbia
School of Medicine
Objectives
1. Learn the background and importance
of clinical trials registration.
2. Identify clinical trials registration
requirements by source and scope.
3. Explore recent and proposed changes in
requirements.
4. Review reporting methods including
electronic uploads and downloads.
Office of Compliance & Quality, University of Missouri-Columbia
School of Medicine
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Why is a registry important?
WHO:
“ A public, complete and readily searchable
registry……will
– Further good research practice
– Assist in making treatment decisions
– Help increase public trust in clinical research”
Office of Compliance & Quality, University of Missouri-Columbia
School of Medicine
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Why is a registry important?
FDAAA (Food & Drug Administration
Amendments Act) of 2007:
The Data Bank (clinicaltrials.gov) will
– Enhance patient enrollment
– Track subsequent progress
– Make the registry publicly available
– Ensure the registry is searchable on the
Internet
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School of Medicine
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Why is a registry important?
NEJM editorial:
– “Mandatory registration represents a critical advance
in making clinical trials of new treatments public
knowledge.”
– “A decade ago a clinical trial could be conducted in
secret…..”
– “With several recent blockbuster
drugs…..breakdowns in communication of trial
results kept safety concerns from doctors and
patients.”
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School of Medicine
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Clinical Trials Registry Chronology
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November 1997 – FDA Modernization Act mandates registration
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February 2000 – clinicaltrials.gov available on the Internet
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September 2000 – Medicare NCD (National Coverage Decision) on
routine costs of clinical trials allowed IF trial is registered in proposed
HCFA registry
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October 2003 – WHO begins dialogue on registration
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September 2004 – ICMJE (International Committee of Medical Journal
Editors) endorses WHO initiative
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November 2004 – Trials Registry Platform recommended during WHO
Ministerial Summit on Health Research, held in Mexico City
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May 2005 – WHO Trials Registry recommendations approved by the
world health Assembly
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School of Medicine
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Clinical Trials Registry Chronology
• January 2006 – AAMC (Association of American Medical Colleges)
calls for registration
• May 2006 – WHO specifies 20 key data elements for clinical trials
registries
• December 2006 – Medicare Coverage Advisory Committee
considers using clinicaltrials.gov in lieu of proposed HCFA registry
• June 2007 – ICMJE (NEJM, June 7, 2007) expands and clarifies
definition of types of trials to be registered
• September 2007 – FDAAA signed into law
• October 2007 – NEJM reiterates ongoing support for clinical trials
registration and the new FDAAA requirements
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School of Medicine
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International Committee of
Medical Journal Editors
“ICMJE adopts the WHO’s definition of
clinical trials 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.’
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School of Medicine
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International Committee of Medical
Journal Editors
Health-related interventions include any
intervention used to modify a biomedical
or health-related outcome (for example,
drugs, surgical procedures, devices,
behavioral treatments, dietary
interventions, and process-of-care
changes).
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School of Medicine
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International Committee of Medical
Journal Editors
Health outcomes include any biomedical or
health-related measures obtained in
patients or participants, including
pharmacokinetic measures and adverse
events. As previously, purely
observational studies (those in which the
assignment of the medical intervention is
not at the discretion of the investigator)
will not require registration.”
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School of Medicine
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Food & Drug Administration
Amendments Act of 2007
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Additional clout for the FDA
Pediatric device & pharmaceutical issues
Conflict of interest on FDA committees
Post-market safety of drugs
Clinical trial data bank
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School of Medicine
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FDAAA Major Changes
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Definition expanded
Phase I excluded
Data elements expanded
Results reporting to be initiated
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School of Medicine
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Applicable Clinical Trial
• Device
– Prospective study of health outcomes
– Compare device interventions
– Pediatric post-market surveillance studies
– Excludes prototype and feasibility studies
• Drug
– Controlled clinical investigation
– Drug subject to FDA requirements
– Excludes Phase I clinical trial
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School of Medicine
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Responsible Party
• Sponsor registers one time for ALL sites
• Investigator who is responsible for
conducting the trial
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School of Medicine
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Data Bank Expansion
Content expanded
– Descriptive information
– Recruitment information
– Location and contact information
– Administrative data
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School of Medicine
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Data Elements
• Descriptive Information
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Brief title, intended for the lay public
Brief summary, intended for the lay public
Primary purpose
Study design
Study phase (for an applicable drug clinical trial)
Study type
Primary disease or condition to be studied, or the focus of
the study
Intervention name and intervention type
Study start date
Expected completion date
Target number of subjects
Outcomes, including primary and secondary outcome
measures
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Data Elements
• Recruitment Information
– Eligibility criteria
– Gender
– Age limits
– Whether the trial accepts healthy volunteers
– Overall recruitment status
– Individual site status
– Whether or not there is expanded access for
those who do not qualify for enrollment
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School of Medicine
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Data Elements
• Location and Contact Information
– Name of sponsor
– Responsible party by official title
– Facility name and contact information
• City, state, zip code for each location
• Toll-free number
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School of Medicine
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Data Elements
• Administrative Data
– Unique protocol identification number
– Other protocol identification numbers, if any
– FDA’s IND/IDE protocol number and record
verification date
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School of Medicine
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Timing
When to register?
Applicable clinical trials register by later of
– 90 days after enactment (by December 26,
2007)
– 21 days after first patient enrolled
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School of Medicine
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Posting of Results
After Drug or Device Approval
Link from clinicaltrials.gov to required information
FDA Information, if applicable
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FDA summary documents
Posted FDA assessments of results
FDA public health advisories
FDA action package of applicable drug
Safety and effectiveness of applicable device
NIH Links
• Medline citations
• NLM database of product labels
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School of Medicine
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Posting of Results
One year later, by September 27, 2008
Registry to include data elements and tables
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Demographic and baseline data
Primary and secondary outcomes
Point of contact about results
Existence of agreements that restrict release
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School of Medicine
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Posting of Results
Three years later, by September 27, 2010
• Future guidance
• Public meeting
– 18 months after enactment (by March 2009)
– for public input on third year rule making.
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School of Medicine
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Adverse Events in Results Data Bank
Regulations must be issued by March, 2009
OR
Adverse Events must be included by September,
2009
Adverse Events
– Serious
– Frequent (>5% within any arm)
– Anticipated & unanticipated
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School of Medicine
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Federal Grants
• Funded in whole or in part
– DHHS
– FDA
– NIH
– AHRQ
• Must submit registry data and results
• Agencies must verify submission before
releasing remaining funds
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School of Medicine
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Reporting Methods
Web page
clinicaltrials.gov
PRS (Protocol Registration System)
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School of Medicine
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Account Application Process
There are two types of PRS accounts:
Organization accounts
• multiple users
• trials conducted at an organization
Individual accounts
• trials conducted by a single investigator
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School of Medicine
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Reporting Methods
Logon
– Each institution designates a PRS
Administrator
– Administrator creates logons
– Contact Susan Koenig at
[email protected]
Office of Compliance & Quality, University of Missouri-Columbia
School of Medicine
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Reporting Methods
• Create a Record
– Entry is saved, modify as needed
– “Complete” –when edits are finished
– Modify at any time and mark again as
“complete”
• PRS Administrator will “approve” and
“release”
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School of Medicine
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Reporting Methods
• Clinicaltrials.gov staff will review before
entry is available for public view
• Appear on web site within 2-5 days
• NCT number assigned at that time
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School of Medicine
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Reporting Methods
Electronic Reporting
– Records can be uploaded and downloaded
– Must be in PRS document format
– One upload can contain multiple records
– Records with errors are placed in “complete”
status
– Modify errors by corrected upload or through
on-line edit
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School of Medicine
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Clinical Trials Registration
Process to navigate sometimes overlapping requirements
University of Missouri - Columbia
Proposed Protocol for
Human Subject Research
Yes
IRB Approved?
Does study
assign humans to health-related
interventions to evaluate effects
on health outcomes? (required
for journal publication)
No
For more information about
clinicaltrials.gov, visit
Http://prsinfo.clinicaltrials.gov
No
For more information about
UM-Columbia registration, call
573-882-8957
Does study involve a drug
or device clinical trial, excluding
Phase I or device prototypes?
(FDA requirement)
Yes
Is this a multi-site
trial sponsored by an
outside entity?
Yes
Yes
No
Does study involve
hospital, clinic or ancillary claims
for Medicare beneficiaries?
(Medicare requirement)
No
No
Yes
Obtain assistance or logon from
UM - Columbia clinicaltrials.gov
administrator at
[email protected]
The sponsor
will register
Note: Multi-site trials
should be registered by the
investigator at the lead site.
Register study on clinicaltrials.gov
prior to enrollment activities
No need to
register
Note: Registration of
observational studies is
optional.
For more information or assistance with registration, contact the Office of Compliance & Quality, University of Missouri Columbia School of Medicine, 573-882-8957.
Office of Compliance & Quality, University of Missouri-Columbia
School of Medicine
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Office of Compliance & Quality
882-8957
[email protected]
[email protected]
https://sp.missouri.edu/sites/researchbudgetresources/default.aspx
Office of Compliance & Quality, University of Missouri-Columbia
School of Medicine
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