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OEWG Kick-Off Meeting

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Overview of Revised CTEP Schema for Review of Cooperative Group Treatment Studies OEWG Kick-Off Meeting Meg Mooney, MD Chief, Clinical Investigations Branch – PowerPoint PPT presentation

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Title: OEWG Kick-Off Meeting


1
Overview of Revised CTEP Schema for Review of
Cooperative Group Treatment Studies

OEWG Kick-Off Meeting Meg Mooney, MD Chief,
Clinical Investigations Branch CTEP, DCTD, NCI
March 24, 2010
2
Review Process for Group Tx Trial Proposals
  • All Cooperative Group study proposals will be
    initially evaluated as LOIs (Letters of Intent)
    OR Concepts, independent of entity holding the
    IND or if study IND-exempt, and undergo full
    scientific review (developmental strategy is no
    longer a review category)
  • LOIs (CTEP Protocol Review Committee)
  • Studies in Response to CTEP Mass Solicitation
  • Phase 1 and Phase 1/2 Studies
  • Phase 2 (and 1/2) Studies lt100 Patients
  • Transition Period All Phase 2 Studies in
    diseases without SCs
  • Post-meeting update Group Phase 2 (and 1/2) gt
    100 pts without SCs are now Concepts.
  • Concepts (Steering Committee (SC) Evaluation)
  • Phase 2 (and 1/2) Studies 100 Patients
  • Phase 3 Studies - Exception for OPEN Internatl
    Phase 3 Transition Period Phase 3 Studies in
    diseases without SCs will be reviewed by CTEP
    Concept Review Committee

3
Phase 2 Trials Eligible for New Reimbursement
  • Phase 2 Treatment Trials with
  • Total sample size up to 125 patients (eligible
    ineligible) for a treatment arm does not
    include patients screened as part of the trial
    for assignment to a treatment arm (to be
    determined by CTEP at LOI/Concept approval)
  • Trials may have a simple dose finding cohort, but
    it must be primarily a phase 2 trial
  • Phase 2 Tx Trials with larger sample sizes are
    eligible for annual nominations to receive
    complexity funds
  • Phase 2/3 Tx Trials are eligible for annual
    nominations to receive complexity funds

4
Phase 2 Trials New Reimbursement
  • Total Cost of 5,000
  • 2,000 paid by Group leading or endorsing a trial
    and the additional total cost of 3,000 paid to
    Group via CTSU (if non-endorsing and on CTSU
    menu, CTSU pays full 5,000 total cost to Group
    rules for Group phase 2 trial going on CTSU menu
    remain unchanged)
  • Screened patients receive 500 only if not
    assigned to a treatment arm (this is a current
    estimate only might be less than 500)
  • Ancillary payments for collection of biospecimens
    included in 5,000 total cost
  • CCOPs paid in equivalent treatment credits

5
Implementation of Revised Review Process
  • Timeline
  • Implementation Date March 15th 2010 for newly
    submitted proposals
  • If SC has gt2 new studies on Agenda (and cannot
    accommodate a 3rd phase 2 Concept, study will go
    to CTEP for review)
  • New process will be closely monitored
  • Non-CTEP IND or IND-Exempt Phase 2 Studies
  • Will come in on CTEP LOI or Concept form per the
    schema/criteria
  • Groups need to designate on LOI form the proposal
    is for non-CTEP IND study (and list
    investigational agent) or an IND-exempt study
  • IB will be required for non-CTEP IND agents if
    agent is investigational
  • IB and/or adequate information supplied in LOI or
    Concept for non-CTEP IND agents that are
    commercially available.
  • Transition Period Only for Non-CTEP IND LOIs
    or Concepts NOT going to a SC CTEP will accept
    protocol as LOI or Concept until 5/1/2010 but
    it will be reviewed as a study proposal (not as a
    protocol)

6
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7
OEWG Target Timeline Phase 2 Trial 210 days
All Timelines in Calendar Days Timeline pauses
if industry negotiations cause delay
Post-meeting note Phase 1/2 or 2 Concepts of gt
100 patients have a target timeline of 240 days
(210 days 30 days added to Concept approval
stage 240 days).
Timeline excludes contracting, drug supply, IRB,
FDA (Subsequently changed during implementation
in that IRB is no longer considered a time-out.
Please see Time-Out SOP.)
Protocol terminated if not activated in 18 months
Activation for Target and Final (Drop-Dead)
Timelines is defined as trial being OPEN for
patient enrollment
8
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9
Phase 1/Phase 2 Timeline Unsolicited LOIs
Non-CTEP IND or No IND
Phase 1 and Phase 2 lt100 Patients
Post-meeting update For the most updated OEWG
timelines, please see the Timeline Charts on the
OEWG website at http//ctep.cancer.gov/SpotlightOn
/OEWG.htm
10
Transition Period Pediatric, Brain/CNS,
Melanoma Studies will not have SCs until end CY
2010, large Phase 2 and Phase 3 proposals will be
evaluated by CTEP Concept or Protocol Review
Committee until SCs up and running
11
Concept Review Protocol Development Process in
Detail with Timelines

OEWG Kick-Off Meeting Meg Mooney, MD Chief,
Clinical Investigations Branch CTEP, DCTD, NCI
March 24, 2010
12
OEWG Target Timeline Phase 3 Trial 300 days
All Timelines in Calendar Days
Timeline pauses if industry negotiations cause
delay
Feedback on major challenges
If registration trial, FDA review in 21 (to 30)
days
Concept review
Concept revision/ review cycles
Protocol development
Protocol review
Protocol revision/review cycles Forms development
0
30
90
300
180
210
Time (days)
Timeline excludes IRB, contracting, drug supply
(Subsequently changed during implementation in
that IRB is no longer considered a time-out.
Please see Time-Out SOP.)
Protocol terminated if not activated in two years
Activation for Target and Final (Drop-Dead)
Timelines is defined as trial being OPEN for
patient enrollment
13
Group Phase 3 Timeline Steering Committee
Evaluation
Post-meeting update For the most updated OEWG
timelines, please see the Timeline Charts on the
OEWG website at http//ctep.cancer.gov/SpotlightOn
/OEWG.htm
14
Group Phase 2 Timeline Steering Committee
Evaluation
Post-meeting update For the most updated OEWG
timelines, please see the Timeline Charts on the
OEWG website at http//ctep.cancer.gov/SpotlightOn
/OEWG.htm
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