Transcript Document 7180781

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
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 <100 Patients
Transition Period: All Phase 2 Studies in diseases without SCs
Post-meeting update: Group Phase 2 (and 1/2) > 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 Internat’l Phase 3
Transition Period: Phase 3 Studies in diseases without SCs will
be reviewed by CTEP Concept Review Committee
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
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”
Implementation of Revised Review Process
• Timeline:
– Implementation Date: March 15th 2010 for newly submitted proposals
– If SC has >2 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 nonCTEP 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)
OEWG Target Timeline Phase 2 Trial – 210 days
All Timelines in Calendar Days
Timeline pauses if industry negotiations cause delay
LOI
review
0
LOI
revision
/ review
30
60
Protocol
revision/review
and forms
development
Protocol
review
Protocol
development
120
Post-meeting note:
Phase 1/2 or 2
Concepts of > 100
patients have a
target timeline of
240 days (210 days
+ 30 days added to
Concept approval
stage = 240 days).
150
210
Time (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
Phase 1/Phase 2 Timeline: Unsolicited LOIs – Non-CTEP IND or No IND
Phase 1 and Phase 2 <100 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
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
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
OEWG Target Timeline Phase 3 Trial – 300 days
All Timelines in Calendar Days
Timeline pauses if industry negotiations cause delay
Feedback on
major challenges
Concept
review
0
If registration trial, FDA
review in 21 (to 30) days
Concept
revision/ review
cycles
30
Protocol
development
90
Time (days)
Protocol
review
180
Protocol revision/review
cycles
Forms development
210
300
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
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
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