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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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Presentation Transcript
slide1
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
Outline
  • Introductions
  • Project background
  • Progress to date
  • Goals of the day
background
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

background1
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
current model for adverse symptom reporting in cancer trials
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 direct reporting of symptoms 1
Patient

Experiences

Symptom

Patient direct reporting of symptoms (1)

Research

Database

patient direct reporting of symptoms 2
Patient

Experiences

Symptom

Clinician

Patient direct reporting of symptoms (2)

Research

Database

patient direct reporting of symptoms 4
Patient

Experiences

Symptom

Clinician

Patient direct reporting of symptoms (4)

Assign attribution; initiate expedited reporting

Research

Database

patient direct reporting of symptoms 5
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
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
Patient adverse symptom reports better correlate with functional status than clinician reports
  • Basch: JNCI, 2009
clinician ctcae reporting is unreliable
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
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
Clinician-Reported Diarrhea
  • Dueck: Unpublished Data, 2010
patient reported diarrhea
Patient-Reported Diarrhea
  • Dueck: Unpublished Data, 2010
nci contract hhsn261200800043c
NCI Contract HHSN261200800043C

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

  • Initiated October 2008
mission
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
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-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
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
slide23
Wiki

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

pro ctcae presentations 2009 10
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
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
Survey Highlights*729 Stakeholders in Cooperative Groups

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

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