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Elizabeth B. Andrews, Ph.D., M.P.H.

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Title: Core set Author: stj11454 Last modified by: CDER USER Created Date: 7/20/1998 2:36:45 PM Document presentation format: On-screen Show Other titles – PowerPoint PPT presentation

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Title: Elizabeth B. Andrews, Ph.D., M.P.H.


1
Elizabeth B. Andrews,Ph.D., M.P.H.
  • Director, Worldwide Epidemiology

2
Risk Management Plan
3
GW Program of Responsible Product Stewardship
  • Scientific foundation to understand the risks and
    predictors of serious events
  • Communication program to educate physicians,
    pharmacists and patients
  • Program evaluation to determine if and when
    additional efforts are warranted

4
Risk Management StrategyAn Integrated Approach
Communication
Program Evaluation
Risk Definition
  • Appropriate Use Program
  • Healthcare Practitioners
  • Pharmacists
  • Patients
  • Testing Comprehension of Communication Vehicles
  • Tracking Awareness and Source of Knowledge
  • Lotronex Utilization Study
  • Ongoing pharmacovigilance

Mechanistic Studies
Clinical Studies
Epidemiologic Research
Systematic Evaluation
5
Risk Management StrategyAn Integrated Approach
Communication
Program Evaluation
Risk Definition
  • Appropriate Use Program
  • Healthcare Practitioners
  • Pharmacists
  • Patients
  • Testing Comprehension of Communication Vehicles
  • Tracking Awareness and Source of Knowledge
  • Lotronex Utilization Study
  • Ongoing pharmacovigilance

Mechanistic Studies
Clinical Studies
Epidemiologic Research
Systematic Evaluation
6
Risk Management StrategyAn Integrated Approach
Program Evaluation
Risk Definition
Communication
  • Appropriate Use Program
  • Healthcare Practitioners
  • Pharmacists
  • Patients
  • Testing Comprehension of Communication Vehicles
  • Tracking Awareness and Source of Knowledge
  • Lotronex Utilization Study
  • Ongoing pharmacovigilance

Mechanistic Studies
Clinical Studies
Epidemiologic Research
Systematic Evaluation
7
Risk Management StrategyAn Integrated Approach
Risk Definition
Program Evaluation
Communication
  • Appropriate Use Program
  • Healthcare Practitioners
  • Pharmacists
  • Patients
  • Testing Comprehension of Communication Vehicles
  • Tracking Awareness and Source of Knowledge
  • Lotronex Utilization Study
  • Ongoing pharmacovigilance

Mechanistic Studies
Clinical Studies
Epidemiologic Research
Systematic Evaluation
8
Risk Management StrategyAn Integrated Approach
Communication
Program Evaluation
Risk Definition
  • Appropriate Use Program
  • Healthcare Practitioners
  • Pharmacists
  • Patients
  • Testing Comprehension of Communication Vehicles
  • Tracking Awareness and Source of Knowledge
  • Lotronex Utilization Study
  • Ongoing pharmacovigilance

Mechanistic Studies
Clinical Studies
Epidemiologic Research
Systematic Evaluation
9
Risk Management Strategy Opportunity
  • Recent launch
  • Interest high
  • Many options considered
  • Strategy consistent with the evidence
  • Appropriate patients
  • Early recognition

10
Risk DefinitionEpidemiology Program
11
Contributions of Epidemiology Studies vs Clinical
Trials
  • Large numbers of patients
  • Real world experience
  • more heterogeneous patients
  • treatment and compliance less controlled
  • Estimate infrequent/rare events
  • Explore risk factors for events
  • Trade depth (trial) for breadth (epidemiology)

12
Program of Epidemiology Research Questions
Addressed
  • Frequency of complications of constipation in
    patients treated with Lotronex in actual practice
  • Frequency of ischemic colitis in patients treated
    with Lotronex compared with other populations
    persons with IBS, persons who consult GI
    specialists, general population
  • Potential risk factors

13
General Study Designs
  • Observational cohort studies to define incidence
    of complications of constipation and ischemic
    colitis
  • Nested case-control studies to evaluate risk
    factors

14
Methodologic Issues
  • Challenges
  • Spectrum of disease
  • ICD-9 code is non-specific
  • Approaches
  • Broad capture of ICD-9 codes
  • Development of computer algorithms
  • Validation through chart review


15
Epidemiology Commitments
  • GW and FDA agreed to a Phase IV observational
    cohort study
  • 10,000 patients treated with Lotronex
  • GW is modifying the study to include
    complications of constipation

16
Observational Cohort Study of Safety in Patients
Receiving Lotronex
  • Objectives
  • 1. Incidence and risk factors for complications
    of constipation in patients receiving Lotronex
  • 2. Incidence and risk factors for ischemic
    colitis in patients receiving Lotronex
  • 3. Incidence of these events in the general
    population and in patients with IBS not receiving
    Lotronex

17
Observational Cohort Study of Safety in Patients
Receiving Lotronex
  • Datasource
  • United HealthCare (UHC) Research Database
  • Second largest health care company in the United
    States gt300,000 physicians, gt14 million members
  • UHC Research Database subset comprised of 7
    million members since 1990 with medical and
    prescription coverage

18
Observational Cohort Study of Safety in Patients
Receiving Lotronex
  • Study Conduct
  • Phase IDevelopment of algorithms using
    computerized claims to identify patients with
    diagnoses under study
  • Phase IIIncidence of events in patients
    receiving Lotronex
  • Phase IIIFurther characterize events in patients
    with IBS, and in general population

19
Utilization Study
  • QuestionDescriptive study of utilization
    patterns over time in United HealthCare
  • PopulationAll persons receiving a prescription
    for Lotronex
  • AnalysisDescriptive evaluation of users by
  • Age
  • Gender
  • History of constipation
  • History of IBS-related visits and prescriptions

20
Utilization Study
  • This study is also part of Program Evaluation
  • Systematic evaluation
  • First review December 2000, quarterly thereafter

21
EpidemiologyProgram of Research
  • Study Population Timeline
  • Phase IV Study of Safety UHC Research First
    interim in 10,000 patients Database report
    treated with Lotronex 7 million members
    December 2000
  • Disease frequency/ GPRD (UK) Completerisk
    factors in 6 million patients December 2000
    general population and patients with IBS

22
EpidemiologyProgram of Research (continued)
  • Study Population Timeline
  • Disease frequency TN Medicaid Complete Fall
    and risk factors 1.4 million patients 2002
  • Disease frequency Mayo Clinic Complete Fall
    and risk factors Foundation 2002
    Residents of Olmstead County
  • Case control study Patients in GW Initiate
    Summerin GW Clinical Trials Clinical Trials
    2000

23
Risk DefinitionClinical Studies
24
Program of Clinical Studies
  • Study on constipation management
  • Laxatives
  • Interruption of therapy
  • Dose reduction
  • Studies for other indications/populations
  • Male IBS
  • Functional Dyspepsia

25
Risk DefinitionMechanistic Studies
26
Mechanistic Studies
  • Phase IV commitment
  • Cultured endothelial cell integrity
  • Mesenteric blood flow in humans with PET scanning
  • Coagulation factors

27
Risk Management StrategyAn Integrated Approach
Communication
Program Evaluation
Risk Definition
  • Appropriate Use Program
  • Healthcare Practitioners
  • Pharmacists
  • Patients
  • Testing Comprehension of Communication Vehicles
  • Tracking Awareness and Source of Knowledge
  • Lotronex Utilization Study
  • Ongoing pharmacovigilance

Mechanistic Studies
Clinical Studies
Epidemiologic Research
Systematic Evaluation
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