Innovation issues for regulators society and industry overview of conference topics
Download
1 / 22

Innovation; issues for regulators, society and industry. Overview of Conference topics - PowerPoint PPT Presentation


  • 66 Views
  • Uploaded on

Innovation; issues for regulators, society and industry. Overview of Conference topics. Alasdair Breckenridge Medicines and Healthcare products Regulatory Agency London 23 September 2008.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about ' Innovation; issues for regulators, society and industry. Overview of Conference topics' - ziya


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
Innovation issues for regulators society and industry overview of conference topics

Innovation; issues for regulators, society and industry.Overview of Conference topics

Alasdair Breckenridge

Medicines and Healthcare products Regulatory Agency

London 23 September 2008


“It is a frustrating aspect of benefit-risk evaluation that there is no defined and tested algorithm or summary metric that combines benefit and risk data that might permit straightforward quantitative comparisons of different treatment options, which in turn might aid decision making”

CIOMS, 1998.


Current perceptions
Current perceptions that there is no defined and tested algorithm or summary metric that combines benefit and risk data that might permit straightforward quantitative comparisons of different treatment options, which in turn might aid decision making”

  • Approval thresholds heightening

  • Increased focus on safety

  • Regulators dislike uncertainty

  • Increasing cost of drug development

  • Demand for increased transparency

  • Negative perceptions of pharmaceutical industry and regulators



Benefits of an agreed framework
Benefits of an agreed framework them to undertake benefit : risk assessments?

  • Shared understanding of issues between industry and regulator.

  • Consistency in expressing benefit and risk.

  • Transparency of regulatory decisions

  • Tool to compare products


Methods of assessing benefit
Methods of assessing benefit them to undertake benefit : risk assessments?

  • Nature of disease-incidence

  • natural history

  • impact of treatment

  • consequences of no intervention

    • Purpose of treatment-prevention

      prevention of recurrence

  • symptomatic treatment

  • cure

    • Assessment of benefit-morbidity

      mortality

      symptoms

      quality of life


  • Methods of assessing risk
    Methods of assessing risk them to undertake benefit : risk assessments?

    • Development or post marketing

    • ADRs affecting different systems

    • Seriousness of ADRs


    Under-reporting them to undertake benefit : risk assessments?

    Reporting bias

    Quality of reports

    Cannot estimate frequency of events

    • Spontaneous reports of ADRs


    Knowledge them to undertake benefit : risk assessments?

    Time


    Timing of market authorisation them to undertake benefit : risk assessments?

    MA

    Knowledge

    Time


    Earlier to market? them to undertake benefit : risk assessments?

    MA

    Knowledge

    Post-licensing assessment

    Time


    “A systematic approach to population based drug safety surveillance which seeks to ascertain the number of adverse events by means of a continuous pre-organised process.”

    • Active Surveillance


    Record of drug exposure surveillance which seeks to ascertain the number of adverse events by means of a continuous pre-organised process.”

    Record of outcomes

    Access to detailed information about individual cases

    • Data requirements for

    • active surveillance


    Computerised databases of users and non users surveillance which seeks to ascertain the number of adverse events by means of a continuous pre-organised process.”

    Medical records

    • Sources of information for

    • active surveillance


    British society of rheumatology biological register 1
    British Society of Rheumatology Biological Register(1) surveillance which seeks to ascertain the number of adverse events by means of a continuous pre-organised process.”

    • For patients with severe RA prescribed anti TNF αmedicines.

    • To receive drug, patient must be entered on central register.

    • Short and long term ADRs documented.

    • Cohort of similar patients prescribed conventional DMARDs


    British society for rheumatology biological register 2
    British Society for Rheumatology Biological Register(2) surveillance which seeks to ascertain the number of adverse events by means of a continuous pre-organised process.”

    • Rheumatologists contacted 6 monthly about specific patients

    • Data on severe infections and hospital admissions obtained

    • Patient diaries

    • Patients flagged with ONS to ascertain new cases of cancer and deaths

    • Over 20000 patients on register


    Gprd population figures
    GPRD: population figures surveillance which seeks to ascertain the number of adverse events by means of a continuous pre-organised process.”

    • Contains 6.1 million acceptable patients from 464 active practices

    • Currently collecting data on 3.58 million active patients from 405 up to standard practices

    • >45% of patients have 5 or more years of follow-up, >60% have at least 3 years

    • Contains over 40 million patient-years data

    • Geographically representative


    The Benefit-Risk Spectrum surveillance which seeks to ascertain the number of adverse events by means of a continuous pre-organised process.”

    RISK

    The worst balance

    Forrestricted use only

    Balance may require further study

    major

    Acceptable balance

    minor

    Excellentbalance

    minor

    major

    BENEFIT


    Principle of three
    Principle of three surveillance which seeks to ascertain the number of adverse events by means of a continuous pre-organised process.”

    • Seriousness, duration, incidence

      as applied to adverse reactions

    • Seriousness, chronicity, extent of control or cure

      as applied to benefit

      Describe verbally or numerically


    Aspirin
    Aspirin surveillance which seeks to ascertain the number of adverse events by means of a continuous pre-organised process.”

    3 = high, 2 = medium, 1 = low, 0 = no effect


    Shortcomings of models
    Shortcomings of models surveillance which seeks to ascertain the number of adverse events by means of a continuous pre-organised process.”

    • Do not enhance objectivity of benefit-risk decision making

    • Time consuming

    • Conflict between stakeholders in assessment


    Benefit risk outstanding issues
    Benefit-risk : outstanding issues surveillance which seeks to ascertain the number of adverse events by means of a continuous pre-organised process.”

    • Need for lexicon of terminology

    • Framework for benefit: risk assessment in which different models might be used

    • Different models for different situations

    • Agreed framework would improve underlying science of innovation

    • Importance of taking patient preferences into account

    • Learning from other disciplines, including HTA

    • Communication difficult but crucial


    ad