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Best Practices in Meeting Your Postmarketing Study Commitments

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Best Practices in Meeting Your Postmarketing Study Commitments. Cyndi Verst-Brasch, Pharm.D., M.S. ... N o r t h A m e r I c a E u r o p e A s I a / P a c I ... – PowerPoint PPT presentation

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Title: Best Practices in Meeting Your Postmarketing Study Commitments


1
Best Practices in Meeting Your Postmarketing
Study Commitments
  • Cyndi Verst-Brasch, Pharm.D., M.S.
  • Vice President, Late Phase, Kendle

2
Postmarketing Commitment (PMC) Overview
  • PMCs on the Rise
  • PMC Costs on the Rise
  • PMC Study Types
  • PMCs Per Drug Classification
  • PMCs Per Therapeutic Classification

3
During 1998-03, 73 of NME Associated with PMCs
Source Tufts Center for the Study of Drug
Development Impact Report, Volume 6, Number 4,
July/August 2004
4
PMC Patients, Numbers, and Costs on the Rise
Source Tufts Center for the Study of Drug
Development Impact Report, Volume 6, Number 4,
July/August 2004
5
PMCs Per Drug Classification
Source Tuft Center for the Study of Drug
Development Impact Report, Volume 6, Number 4,
July/August 2004
6
PMCs Per Drug Class
Source Tuft Center for the Study of Drug
Development Impact Report, Volume 6, Number 4,
July/August 2004
7
PMC Study Types-Safety/ADR Increased Frequency
Source Tuft Center for the Study of Drug
Development Impact Report, Volume 6, Number 4,
July/August 2004
8
Best Practices in Meeting Your PMCs
  • Timely Submissions
  • Reporting Requirements
  • FDAs Review of Reports

9
Timely Submissions
  • Protocols
  • Postmarketing Study Protocols
  • Accelerated approval clinical benefit
    studies-submitted prior to application approval
  • Other PMCs-submitted within three months after
    the date of the postmarketing study commitment
  • Protocols for studies requiring an IND should be
    submitted to the appropriate IND, with copy of
    the cover letter to NDA, ANDA, or BLA
  • Protocols for studies not requiring IND (e.g.,
    toxicology studies) should be submitted to NDA,
    ANDA, or BLA
  • In all cases, final protocol should be
    accompanied by
  • Proposed timelines for patient enrollment (or
    initiation of animal study), completion of study,
    and submission of the final report to FDA
  • Guidance for Industry Reports on the Status of
    Postmarketing Studies-Implementation of Section
    130 of the Food and Drug Administration
    Modernization Act of 1997

10
Reporting Requirements
  • Postmarketing Study Status Reports
  • Status reports for both human drugs and
    biological products should be submitted annually
    until a final study report submitted to FDA (21
    CFR 314.81(b)(2)(vii))
  • Annual study reports are due within 60 days of
    the anniversary of the NDA, ANDA, or BLA approval
    in US once completed
  • The FDA will notify Sponsor when the study
    commitment has been met
  • Final Reports
  • Submitted as a separate submission to NDA, ANDA,
    or BLA in original and 2 copies with form FDA
    356h and a cover letter attached
  • Guidance for Industry Reports on the Status of
    Postmarketing Studies-Implementation of Section
    130 of the Food and Drug Administration
    Modernization Act of 1997

11
Timeframes for FDAs Review of Reports
  • Annual Status Reports
  • FDA will review reports within three months of
    receipt
  • If FDA disagrees with the categorization of the
    status of the study, Sponsor will be contacted
    for clarification
  • Study Final Reports (FRs)
  • Many FRs are submitted with supplemental
    application to modify product labeling
  • FDA will review under established PDUFA timelines
  • Those FRs not submitted for product labeling
    modification, the FDA will review within 1 year
    of receipt
  • Guidance for Industry Reports on the Status of
    Postmarketing Studies-Implementation of Section
    130 of the Food and Drug Administration
    Modernization Act of 1997

12
Safety/Pharmacovigilance-Focused PMCs
  • Recent Examples of Safety-Focused PMCs
  • Safety-Focused Study Considerations
  • Operational Considerations
  • Regulatory Considerations

13
PMC Study Types-Safety/ADR Increased Frequency
Source Tuft Center for the Study of Drug
Development Impact Report, Volume 6, Number 4,
July/August 2004
14
2005 Safety-Focused PMCs Examples
  • http//www.accessdata.fda.gov/scripts/cder/pmc/ind
    ex

15
Safety Study Considerations
  • Objectives
  • Identify previously unrecognized safety issues
    (hypothesis-generation)
  • Investigating possible hazards (hypothesis-testing
    in order to confirm causal association)
  • Confirming the expected safety profile under
    marketed conditions
  • Design
  • Prospective, open-label, observational, possible
    cohort comparison, real world,
    pharmacoepidemiological
  • Inclusion/Exclusion Criteria
  • Limited criteria representative of general
    population of intended users
  • Intercurrent illnesses and concomitant
    medications permitted
  • Statistical Plan
  • Valid analyses with sample size justifications
    (typically large N)

16
Safety Study Operational Considerations
  • Investigator Mix
  • Research savvy and community-based sites
  • Flexible, simple approaches (protocol CRF
    design, data collection, data querying, etc.)
  • Training of paramount importance (IM,
    web-conferencing, CD-ROMs, etc.)
  • Drug Safety Monitoring Board (DSMB), Scientific
    Advisory Board (SAB) to help develop and monitor
    study
  • Technology Mix
  • Handling of voluminous data sets
  • Simple, flexible (paper, fax, EDC)
  • Real-time safety data availability
  • Collection of patient-reported outcomes

17
Safety Study Operational Considerations
  • Cost Containment
  • Site Management
  • On-site monitoring
  • Central monitoring
  • (ICH/GCP 5.18.3 Extent and Nature of Monitoring)
  • Remote monitoring
  • Clinical Data Management
  • Critical data focus
  • Scientific programming of edit checks
  • Data cleaning querying
  • Project Management
  • Efficient integrative technology
  • Automated processes

18
Safety Study Regulatory Considerations
  • Office of Inspector General (OIG)
  • Research Funding
  • Post-marketing research activities should be
    especially scrutinized to ensure that they are
    legitimate and not simply a pretext to generate
    prescriptions of a drug
  • Payments for research services should be fair
    market value for legitimate, reasonable, and
    necessary services
  • Research contracts that originate through the
    sales or marketing functionsare particularly
    suspect
  • OIG Compliance Program Guidance for
    Pharmaceutical Manufacturers, Federal Register,
    Vol.38, No. 86, May 5, 2003

19
Safety Study European Regulatory Considerations
  • Post-Authorisation Safety Study (PASS) Guidelines
  • To provide studies of greater scientific
    credibility that could withstand peer-review
    scrutiny
  • A formal investigation conducted for the purposes
    of assessing clinical safety of marketed
    medicines in clinical practice
  • Pan-European guidance
  • Very similar to Safety Assessment Marketed
    Medicines (SAMM)
  • Developed in UK in 1994 by working group
    comprised of MCA (now MHRA), CSM, ABPI, BMA, and
    RCGP
  • EMEA Notice to Marketing Authorisation Holders
    Pharmacovigilance Guidelines, 29 January 1999

20
Safety Study European Regulatory Considerations
  • Post-Authorisation Safety Study (PASS) Guidelines
    (cont.)
  • The design of study depends on objectives
    (observational cohort studies, case-control
    studies, case surveillance, and clinical trials)
  • Patients should be representative of general
    population of product users
  • Regulatory requirements
  • Sponsors encouraged to discuss draft protocol
    with authority
  • Must submit finalized protocol and any proposed
    communications to doctors one month before study
    commencement
  • Brief report on study progress every six months
  • Ethic Committee approval required if patients are
    approached for information, additional
    investigations are performed, or treatment
    randomization is required
  • EMEA Notice to Marketing Authorisation Holders
    Pharmacovigilance Guidelines, 29 January 1999

21
Safety Study European Regulatory Considerations
  • Post-Authorisation Safety Study (PASS) Guidelines
    (cont.)
  • An independent advisory board should be appointed
    to oversee the study
  • Decision to prescribe drug as part of routine
    clinical practice before patient is entered into
    study
  • Study payment to doctors to recompense for time
    and expenses should be fair
  • EMEA Notice to Marketing Authorisation Holders
    Pharmacovigilance Guidelines, 29 January 1999

22
Summary
  • PMCs are on the rise and likely here to stay
  • Timely submissions of PMC protocols and study
    status reports are warranted
  • Expectations from Agency delineated in guidance
    documents
  • Safety/ADR postmarketing studies have been
    employed with increasing frequency
  • Protocol, operational and regulatory
    considerations of large, pharmacoepidemiological
    studies
  • Useful insight contained within the European
    Post-Authorisation Safety Study (PASS) Guidelines

23
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