PRO-CTCAE Face-To-Face Meeting #2
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Ethan Basch , M.D. Memorial Sloan-Kettering Cancer Center PROJECT OVERVIEW May 24, 2010 - PowerPoint PPT Presentation


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PRO-CTCAE Face-To-Face Meeting #2 Advancing the Science of Adverse Symptom Monitoring in Cancer Treatment Trials. Ethan Basch , M.D. Memorial Sloan-Kettering Cancer Center PROJECT OVERVIEW May 24, 2010 National Cancer Institute. Outline. Introductions Project background Progress to date

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Ethan Basch , M.D. Memorial Sloan-Kettering Cancer Center PROJECT OVERVIEW May 24, 2010

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PRO-CTCAE Face-To-Face Meeting #2Advancing the Science of Adverse Symptom Monitoring in Cancer Treatment Trials

Ethan Basch, M.D.

Memorial Sloan-Kettering Cancer Center

PROJECT OVERVIEW

May 24, 2010

National Cancer Institute


Outline

  • Introductions

  • Project background

  • Progress to date

  • Goals of the day


Introductions


Background

“A PRO is any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else”

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdfz


Background

  • PROs are standard in multiple settings

    • Symptom efficacy evaluation in clinical trials

    • HRQL

    • Patient satisfaction

    • Patient preferences

  • But not standard for adverse symptom reporting


Patient

Experiences

Symptom

Current Model for Adverse Symptom Reporting in Cancer Trials

Clinician

Interprets

Symptom

Chart

Representation

of Symptom

Data Manager

Interpretation

of Symptom

Research

Database


Patient

Experiences

Symptom

Patient direct reporting of symptoms (1)

Research

Database


Patient

Experiences

Symptom

Clinician

Patient direct reporting of symptoms (2)

Research

Database


Patient

Experiences

Symptom

Clinician

Patient direct reporting of symptoms (4)

Assign attribution; initiate expedited reporting

Research

Database


Patient

Experiences

Symptom

Clinician

Enhance clinical care

Patient direct reporting of symptoms (5)

Assign attribution; initiate expedited reporting

Research

Database


Clinicians systematically downgrade symptoms compared with patients

Basch: NEJM, 2010

Fromme: JCO, 2004

Stromgren: ActaAnesth, 2001

Weingart: Arch Intern Med, 2005

Pakhomov: Am J Man Care, 2008

Sprangers, ActaOncologica, 2000


Patient adverse symptom reports better correlate with functional status than clinician reports

  • Basch: JNCI, 2009


Clinician CTCAE Reporting is Unreliable

N=393

Seen by 1st clinician in office, then 2nd clinician ~15 minutes later

  • Atkinson: SBM, 2010


PROs Better Identify SAEs Early

  • NCCTG 9741: Phase III trial comparing regimens for metastatic colorectal cancer

  • Closed after 841/1,125 patients enrolled due to unexpected excess of early deaths in Arm 1 (“IFL”)

  • Associated with “GI syndrome” including severe diarrhea

  • Diarrhea reporting:

    • Clinicians reported CTCAE each cycle (diarrhea required)

    • Patients reported diarrhea via in HRQL every other cycle

    • Rothenberg: JCO, 2001


    Clinician-Reported Diarrhea

    • Dueck: Unpublished Data, 2010


    Patient-Reported Diarrhea

    • Dueck: Unpublished Data, 2010


    Patient vs. Clinician Diarrheain Arm 1 (IFL)

    • Dueck: Unpublished Data, 2010


    NCI Contract HHSN261200800043C

    Development of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    • Initiated October 2008


    Mission

    Develop a system for patient self-reporting of adverse symptoms in cancer trials which is widely accepted and used; generates useful data for investigators, regulators, clinicians and patients; and is compatible with existing adverse event reporting software systems


    PRO-CTCAE Network

    CBIIT

    DCCPS

    DCP

    DCTD

    Dana-Farber

    Christiana

    N

    E

    T

    W

    O

    R

    K

    N

    C

    C

    C

    P

    NCI

    MD Anderson

    Hartford

    Mayo

    OLOL

    MSKCC

    Coordinating

    Center

    Duke

    Spartanburg

    Penn

    St. Joseph - Orange

    SemanticBits

    ADVISORS

    T

    E

    C

    H

    Cooperative Groups

    FDA

    Industry

    Patient

    Advocates

    Perceptive


    Task-Based Project

    • Task 1: White paper and survey

    • Task 2: Item development

    • Task 3: Cultural literacy

    • Task 4: Cognitive interviews

    • Task 5: Technology development

    • Task 6: Usability testing

    • Task 7: Validation study

    • Task 8: Feasibility study

    • Task 9: Educational materials

    DoneOngoing


    Logistics

    • Multidisciplinary committee for each task

      • NCI representatives

      • FDA representatives as appropriate

      • Patient advocates

      • Methodological expertise

      • Clinical expertise

    • Regular web-enabled teleconferences

      • Digitally recorded

      • Documentation on Wiki


    Wiki

    https://wiki.nci.nih.gov/x/X6_l


    PRO-CTCAE Presentations (2009-10)

    • American Society of Clinical Oncology (ASCO)

    • International Society for Pharmacoeconomics and Outcomes Research (ISPOR)

    • International Society for Quality of Life Research (ISOQOL)

    • Drug Information Association (DIA)

    • caBIG Annual Meeting

    • Society of Clinical Trials (SCT)

    • Society of Behavioral Medicine (SBM)

    • Agency for Healthcare Research and Quality (AHRQ)


    Goals of the Day

    • Project update

      • Information exchange

    • Discuss future directions and challenges

      • Feasibility/implementation/dissemination

      • Methodological/analytic issues

        • Demonstrating does not generate noise

      • Technology development

        • Between-visit reporting

        • Integration with other systems

      • Regulatory issues


    Survey Highlights*729 Stakeholders in Cooperative Groups

    * Full survey results and White Paper available on project Wiki (https://wiki.nci.nih.gov/x/cKul)


    Agenda


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