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ClinicalTrials.gov

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Title: ClinicalTrials.gov


1
ClinicalTrials.gov
  • Presented by
  • Suzanne OShea
  • Baker Daniels LLP
  • 317-569-4649
  • suzanne.oshea_at_bakerd.com

2
Clinical Trial Databases
  • Food and Drug Administration Amendments Act
    enacted September 27, 2007
  • Expanded database includes drugs and devices
  • Nearly all clinical trials
  • Registration and Results
  • No Federal funding unless registered
  • Civil Penalties for failure to register

3
The Responsible Party
  • Sponsor (as defined in 21 CFR 50.3) is default
    responsible party
  • Principal Investigator may be responsible party
    under certain circumstances
  • 42 U.S.C. 282(j)(1)(A)(ix)

4
Principal Investigator
  • May be designated as responsible party by
    sponsor, grantee, contractor or awardee when
  • Responsible for conducting trial
  • Has access to and control over data from the
    clinical trial
  • Has the right to publish the results of the trial
  • Has the ability to meet all the requirements for
    submission of information

5
Important!
  • Be sure to determine if YOU are the Responsible
    Party for your trial!
  • If you are a sponsor investigator, you are most
    likely the Responsible Party, unless that role
    has been delegated to a Principal Investigator
    meeting all criteria.
  • If you are the IND or IDE holder, you may be
    considered the sponsor.
  • If you are the Principal Investigator, you may
    have been designated as the Responsible Party by
    the sponsor.

6
21 CFR 50.3
  • (d) Investigator means an individual who actually
    conducts a clinical investigation, i.e., under
    whose immediate direction the test article is
    administered or dispensed to, or used involving,
    a subject, or in the event of an investigation
    conducted by a team of individuals, is the
    responsible leader of that team.
  • (e) Sponsor means a person who initiates a
    clinical investigation, but who does not actually
    conduct the investigation, i.e., the test article
    is administered or dispensed to or used
    involving, a subject under the immediate
    direction of another individual.
  • (f) Sponsor-investigator means an individual who
    both initiates and actually conducts, alone or
    with others, a clinical investigation, i.e.,
    under whose immediate direction the test article
    is administered or dispensed to, or used
    involving, a subject. The term does not include
    any person other than an individual, e.g.,
    corporation or agency.

7
Registration
  • Purpose to enhance patient enrollment and
    provide a mechanism to track subsequent progress
    of clinical trials.
  • Information must be submitted to
    www.clinicaltrials.gov within 21 days after the
    first patient is enrolled. 42 U.S.C.
    282(j)(2)(C)(ii)

8
Registration transition period
  • Studies of drugs for serious or life-threatening
    disease or condition in which last patient will
    receive intervention before December 26, 2007
    no new registration required.
  • Studies of drugs for serious or life threatening
    disease or condition still ongoing on December
    26, 2007 submit new required information by
    December 26, 2007.
  • Applicable clinical trials were ongoing on
    September 27, 2007 submit new required
    information by September 27, 2008.
  • Applicable clinical trials that enroll first
    patient between September 27, 2007 and December
    6, 2007 submit required information by December
    26, 2007.
  • 42 U.S.C. 282(j)(2)(C)

9
What is an Applicable Clinical Trial?
  • Now includes drug and device trials.
  • Previously, only trials of drugs for serious or
    life threatening diseases or conditions were
    required to register.
  • 42 U.S.C. 282(j)(1)(A)(i)

10
Applicable Clinical Trials-- Devices
  • Prospective clinical study of health outcomes
  • Comparing a device intervention against a control
    in human subjects
  • When device is subject to 510(k), PMA,
    Humanitarian Use Device (HUD), or
  • Pediatric postmarket surveillance studies
  • Excludes small clinical feasibility trial or
    trial of prototype where primary outcome measure
    relates to feasibility rather than health
    outcomes.
  • 42 U.S.C. 282(j)(1)(A)(ii)

11
Applicable Clinical Trials -- Drugs
  • Controlled clinical investigations (Phases II,
    III, and IV) of drugs subject to
  • new drug provisions of Food, Drug and Cosmetic
    Act, including generics, (21 U.S.C. 355)
  • or
  • licensing provisions of Public Health Service
    Act, e.g., blood, blood derivatives, virus,
    vaccine, toxin, antitoxin, allergenics, cell and
    gene therapy. (42 U.S.C. 351)
  • Excludes Phase I trials as defined in 21 CFR
    312.21
  • 42 U.S.C. 282(j)(1)(A)(iii)

12
Certification to FDA
  • INDs submitted to FDA, including amendments,
    must include a certification that all
    requirements of clinicaltrials.gov have been met.
  • FDA will issue a form to use to certify.
  • 42 U.S.C. 282(j)(5)(B)
  • see also slide 31

13
Voluntary Submissions
  • Responsible party for a trial that is
  • not an applicable clinical trial (e.g. Phase I
    trial, see slides 10 and 11)
  • or
  • not required to register (see slides 7 and 8)
  • May submit complete clinical trial information as
    long as all required information is submitted.
  • 42 U.S.C. 282(j)(4)(A)

14
NIH
  • NIH encourages registration of ALL trials
  • whether or not required by law.
  • NIH notice number NOT-OD-08-014

15
ICMJE
  • Note ICMJE recently adopted a recent expanded
    definition of clinical trial to include
    essentially all clinical trials, including Phase
    I trials, but excluding purely observational
    studies.
  • Under this expanded definition, if your trial
    begins enrollment on or after July 1, 2008, an
    ICMJE journal will consider it for publication
    only if it is registered.
  • www.icmje.org

16
Note on Informed Consent
  • FDA regulations to be updated to require
    inclusion in informed consent documents and
    process a statement that clinical trial
    information has been or will be submitted to
    clinicaltrials.gov
  • 21 U.S.C. 505(i)(4)
  • Probably a good idea to include same information
    in informed consent documents in device trials.

17
Updates
  • Updates to reflect changes to clinical trial
    information must be submitted at least once every
    12 months, unless there were no changes.
  • Date of change must be identified.
  • Changes in recruitment status must be reported
    within
  • 30 days.
  • Completion of trial must be reported within 30
    days.
  • 42 U.S.C. 282(j)(4)(C)(i)
  • With the exception of recruitment status,
    individual site status, location, and contact
    information, updates to registration will not
    result in removal of information from the data
    base.
  • 42 U.S.C. 282(j)(4)(C)(ii)

18
Completion
  • The term completion date means the date that
    the final subject was examined or received an
    intervention for the purposes of final collection
    of data for the primary outcome..
  • 42 U.S.C. 282(j)(1)(A)(v)

19
Registration Information
  • Descriptive information
  • title, summary, design, phase, disease or
    condition, start date, expected completion date,
    target number of subjects, primary and secondary
    outcome measures
  • Recruitment information
  • eligibility criteria, gender, age, healthy
    volunteers, overall recruitment status,
    individual site status, availability of
  • treatment IND
  • Location and contact information
  • Administrative data (publicly available only as
    necessary)
  • 42 U.S.C. 282(j)(2)(A)(ii)

20
Expanded RegistrationSearch Categories
  • Disease or condition
  • Name of the intervention
  • Location of trial
  • Age group being studied (including pediatric)
  • Study phase
  • Sponsor
  • Recruitment status
  • National Clinical Trial number
  • Safety issue being studied as primary or
    secondary outcome(by March 27, 2009)
  • Other categories deemed necessary
  • 42 U.S.C. 282(j)(2)(B)(i)
  • Current search categories condition, drug
    intervention, sponsor, and location

21
Results
  • Applicable clinical trials (see slides 10 and
    11)
  • Required to submit registration information (see
    slides 7 and 8)
  • Basic results information must be submitted
    within 1 year of the earlier of the estimated
    completion date, or the actual completion date.
  • 42 U.S.C. 282(j)(3)(E)(i)

22
Delay of Submission of Results Information
  • Director of NIH may provide extension of deadline
    for submission of results information for good
    cause.
  • If applicable trial is completed before drug,
    biologic or device is approved or cleared,
    results information must be submitted within 30
    days of approval or clearance. Responsible party
    must submit certification to Director of NIH.
  • If applicable clinical trial supports a new use
    of already approved or cleared drug, biologic or
    device, results information must be submitted
    within 30 days of approval or clearance of new
    use. Responsible party must submit certification
    to Director of NIH.
  • 42 U.S.C. 282(j)(3)(E)(iii), (iv), (v), and
    (vi)

23
Results Information Waiver
  • Upon written request from responsible party, the
    Secretary may waive the requirement that results
    information be submitted if
  • extraordinary circumstances justify the waiver
    and
  • the waiver is consistent with the public health
    or
  • the waiver is in the interest of national
    security.
  • Within 30 days of any waiver, the Secretary must
    notify the appropriate Congressional committee of
    the waiver and provide an explanation for why the
    waiver was granted.
  • 42 U.S.C. 282(j)((3)(H)

24
Basic Results Information
  • Demographic and baseline characteristics of
    patient sample. Includes number of subjects who
    dropped out or were excluded.
  • Table of values for primary and secondary outcome
    measures for each arm, including results of
    scientifically appropriate tests of statistical
    significance.
  • Point of contact for further scientific
    information.
  • Information whether an agreement exists between
    sponsor and principal investigator that restricts
    ability of principal investigator to discuss
    results of the trial in a public or private
    forum, or to publish results.
  • 42 U.S.C. 282(j)(3)(C)

25
Additional Results Information
  • By September 27, 2010, FDA required to issue new
    regulations pertaining to the submission of
    additional results information.
  • Regulations must pertain to applicable clinical
    trials for drugs, biologics, and devices that are
    approved, licensed or cleared.
  • FDA must decide whether new regulations apply to
    applicable clinical trials for drugs, biologics,
    and devices that are not approved, licensed or
    cleared (whether or not approval, licensure or
    clearance was sought).
  • FDA must decide effective date of new regulations
    e.g., whether additional results information
    must be submitted on applicable clinical trials
    completed more than a year prior to issuance of
    regulations.
  • 42 U.S.C. 282(j)(3)(D)

26
Additional Results Information
  • New regulations will require summary of clinical
    trial and results in non-technical language and
    technical language, if Secretary determines that
    such summaries can be included without being
    misleading or promotional
  • Full protocol or information about the protocol
    as would be helpful to evaluate results of trial
  • Other
  • FDA required to hold public meeting by March 27,
    2009 to get input from interested parties on
    these regulations.
  • 42 U.S.C. 282(j)(3)(D)(iii) and (vii)

27
Adverse Event Information
  • By March 27, 2009, FDA required to issue
    regulations determining best method for including
    information on serious and frequent adverse
    events for drugs (not devices).
  • Frequent adverse event exceeds 5 percent within
    any arm of trial.
  • Regulation is to require information in a form
    useful to and not misleading to patients,
    physicians, and scientists.
  • Information on adverse events will be considered
    basic results information.
  • 42 U.S.C. 282(j)(3)(I)

28
Specifically Required Studies
  • When necessary to protect the public health, the
    Secretary may require registration and results
    information about
  • specific applicable trials completed between
    September 27, 1997 and September 27, 2007
  • or
  • an applicable clinical trial on a drug, biologic
    or device that has not been approved, licensed,
    or cleared.
  • 42 U.S.C. 282(j)(4) (B)

29
Compliance Federal Funding
  • Funding agencies within Department of Health and
    Human Services (e.g., NIH, FDA, AHRQ) will verify
    that required information submitted for
    applicable clinical trials.
  • All required registration and results information
    must be submitted before funding released.
  • Grantee has 30 days to remedy non-compliance by
    submitting required information.
  • Secretary to consult with other funding agencies
    (e.g. Veterans Administration) to develop
    comparable procedures.
  • 42 U.S.C. 282(j)(5)(A)

30
Compliance -- Public Notice
  • If responsible party fails to submit required
    registration or results information, Director of
    NIH shall include in the database a statement
    that responsible party is not in compliance for
  • failing to submit information, or primary or
    secondary outcomes information. This may or may
    not have any bearing on the accuracy of the
    information in the entry.
  • submitting false or misleading information.
  • Database will be searchable on such notices
  • 42 U.S.C. 282(j)(5)(E)

31
Certification in Marketing Applications
  • Certification that all database requirements have
    been fulfilled required in
  • New drug applications, including INDs, ANDAs for
    generic drugs
  • Biologic License Applications, including INDs
  • Device applications IDE, 510(k), PMA, HUD.
  • 42 U.S.C. 282(j)(5)(B)

32
Food, Drug, and Cosmetic Act
  • Prohibited Acts
  • Failing to certify in drug, biologic or device
    marketing application that all required
    information has been submitted
  • Failing to submit required information to
    database
  • Submission of information that is false or
    misleading in any particular
  • 21 U.S.C. 331(jj)(1)

33
Food, Drug, and Cosmetic Act
  • Civil Money Penalties
  • Any person who commits a prohibited act is
    subject to a civil money penalty of not more than
    10,000 for all violations adjudicated in a
    single proceeding.
  • If violation is not corrected within 30 days,
    responsible party may be subject to a civil money
    penalty of not more than 10,000 for each day
    violation is not corrected.
  • 21 U.S.C. 331(jj)(2)

34
Preemption
  • No state or political subdivision of a state may
    require registration of clinical trials or
    inclusion of information relating to clinical
    trials in a database.
  • Submitting information to database about use of
    drug, biologic or device not included in approved
    or cleared labeling is not evidence of a new
    intended use, and is not considered labeling,
    adulteration or misbranding.

35
  • For specific questions
  • wecomply_at_indiana.edu
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