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Navigating the Clinical Trials System and Clinical Trials in the Cooperative Groups

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Navigating the Clinical Trials System and Clinical Trials in the Cooperative Groups ASCO/AACR Workshop on Methods in Clinical Cancer Research Vail, CO – PowerPoint PPT presentation

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Title: Navigating the Clinical Trials System and Clinical Trials in the Cooperative Groups


1
Navigating the Clinical Trials System and
Clinical Trials in the Cooperative Groups
ASCO/AACR Workshop on Methods in Clinical Cancer
Research Vail, CO August 2009
  • Neal J. Meropol
  • Ireland Cancer Center, University Hospitals Case
    Medical Center
  • Case Comprehensive Cancer Center
  • Cleveland, OH

2
Ireland Cancer Center 2011UH Case Medical Center
2
2
3
Philly vs. The Cleve
4
Philly vs. The Cleve
5
Philly vs. The Cleve
6
So you have an idea..
7
Question 1
8
Put it on paper Letter of Intent
  • 3-5 pages
  • Key ingredients
  • Rationale/Background why is this important?
  • Objectives what do you hope to prove?
  • Study population who are the patients?
  • Procedures what is the intervention?
  • Endpoints what will you measure?
  • Statistics how will this study answer the
    question?
  • Accrual can you do what you claim?

9
What will make your LOI stand out?(everyone
wants the same hot drug)
  • Track record of you, your mentor, your
    institution
  • Evidence that you can get the work done quickly
    (time )
  • Importance of the question how will your study
    ultimately contribute to curing more patients
    with cancer?
  • Novelty of the question
  • Preliminary data preclinical rationale
    especially if from your lab, your institution
  • Cost vs. potential payoff
  • Complements other ongoing studies elucidates
    mechanism
  • Well-written, no typos!

10
Resource needs will guide where you shop the
concept
  • Patients (single- vs. multi-institution)
  • Drugs
  • Diagnostics
  • Support for clinical trial staff, treatment,
    correlative studies
  • IRB/regulatory staff
  • Your time
  • Urgency to activate

Cooperative group Industry NCI Your
institution Other granting agencies
11
Often, support for a clinical trial will come
from more than 1 source
  • NCI CTEP, R03, R21, SPORE, R01, Ks, cooperative
    group, etc
  • ACS, AACR, ASCO young investigator awards
  • Foundations
  • Philanthropy
  • Institutional support
  • Industry

12
Working with Industry The Medical Science Liaison
  • Your link with the main office
  • Can provide insight into the current portfolio of
    investigator-initiated studies
  • Can provide insight into company needs
  • Handle LOIs and assist in post-approval logistics
  • They seek to build good will
  • Your success is their success
  • They are not making decisions
  • It doesnt hurt if your mentor has a relationship
    higher up in the organization to have them make
    contact

13
NCI Clinical Trials System
  • NCI Program Descriptions
  • http//www.cancer.gov/aboutnci/organization/
  • Org Charts
  • http//www1.od.nih.gov/oma/manualchapters/manageme
    nt/1123/nci.pdf 

14
CTEP FDA Concept Review
NCI Extramural Divisions
As of April 2004
15
CTEP FDA Concept Review
CTEP Organizational Chart
As of April 2004
16
CTEP FDA Concept Review
CTEP Organizational Chart
Non-Coop Group
Coop Groups
As of April 2004
17
The CTEP LOIhttp//ctep.cancer.gov/protocolDevelo
pment/letter_of_intent.htm
  • Patient characteristics
  • Phase
  • Treatment plan
  • Rationale/Hypothesis
  • Lab correlates
  • Endpoints/Stats
  • Monthly accrual
  • Sample size
  • Start date/End date
  • Track record with study population
  • Competing studies
  • Support
  • PI

18
CTEP Evaluation Criteria
  1. Strong scientific hypothesis
  2. Supporting preliminary data and/or a strong
    rationale
  3. Adequate patient accrual
  4. Innovative and well-justified correlative studies
  5. Ability to meet regulatory requirements
  6. Not duplicative
  7. Agent availability
  8. Industry sponsor concurrence

19
Question 2
20
What is a Cooperative Group?
  • Clinical Trials Cooperative Groups established in
    1955
  • NIH U10 cooperative agreement (assistance
    rather than acquisition mechanism) compete
    every 6 years
  • Major emphases
  • definitive studies or preparatory efforts for
    these studies
  • combined modality approaches
  • translational research, correlating biologic
    insights gained from the laboratory with disease
    behavior and treatment outcome
  • Goals Improve therapy, Adjunct studies, Cancer
    Control, Clinical trials methodology
  • 20,000 patients enrolled annually 100M annual
    budget

21
Cooperative Group Structure
  • Three required components headquarters,
    statistical/data management center,
    investigators/institutions
  • Four main type disease (e.g. GOG), modality
    (e.g. RTOG), expertise (e.g. COG), multiumodality
    (e.g. ECOG)
  • Examples ACOSOG, ACRIN, SWOG, RTOG, GOG, NCCTG,
    CALGB, ECOG, COG, NSABP

22
Disease vs. Modality Committees
  • Disease Committees
  • the driver of phase III trials
  • Included as components of the U10 grant
  • Not all types of cancer are represented in every
    group
  • Modality Committees
  • Vary by group
  • May stand alone or be embedded in operations
    portion of U10 grant
  • May play supportive role or conduct studies
  • Examples surgery, radiation, developmental
    therapeutics, pathology/laboratory science
  • Cross individual disease barriers

23
Developmental Therapeutics Committees
  • May spearhead studies or conduct correlatives
    embedded in other trials
  • Pharmacogenetics
  • Population pharmacology
  • New drug development
  • Disease-independent correlatives
  • Orphan diseases
  • Special populations
  • Organ dysfunction, elderly

24
Question 3
25
How to break in
  • Note Cooperative Group leadership is dependent
    upon young investigators, and notices talent
  • Write a letter to introduce yourself to the group
    and committee chair
  • Have your mentor do the same your local mentor
    can help by continuing to bring your name forward
  • Make an appointment to meet with the committee
    chair at the next group meeting
  • Contribute to discussion at meetings be visible
  • Volunteer to write up old data
  • Pitch concepts dont forget about archival
    tissue and data
  • Written and oral presentations should be more
    complete and polished than those of established
    investigators

26
The Players at Macro Level
Steering Com. Task Force
Intergroup
Cooperative Group
Concept level
CTEP
Industry
Protocol level
FDA
CTSU
CIRB
27
The Relationship with Industry
  • The public system is dependent upon industry
    support
  • Pharma not only supplies drug it is a major
    support mechanism for correlative science and
    increasingly for administrative costs (
    accrual)
  • CRADAs (cooperative research development
    agreements) mandate dual sign-off
  • Find shared goals
  • Recognize your value and that of your industry
    partner
  • Remember you are more than a source of patients

28
Levels of cooperative group review
  • Disease committee chair
  • Disease committee core members
  • Your cooperative groups executive committee and
    lab science committee
  • NCI disease Task Force
  • NCI disease Steering Committee
  • Cancer Therapy Evaluation Program (CTEP)
  • Then, write a protocol.

29
NCI Steering Committees and Task Forces
  • Implemented in response to NCI Clinical Trials
    Working Group report regarding conduct of phase
    III clinical trials
  • Effort to ensure involvement of all
    constituencies, including those not participating
    in cooperative groups (e.g. RO1 investigators,
    SPORE investigators)
  • Effort to improve coordination, reduce redundancy
  • Effort to streamline ultimate NCI review, by
    beginning CTEP involvement earlier in the
    development process

30
GI Steering Committee Charge
  • Phase III concept development, evaluation,
    prioritization
  • Monitoring phase III trials
  • Large, multigroup randomized phase II trials
  • Organize State of the Science Meetings
  • Create Task Forces as appropriate

31
Example Gastrointestinal Cancer
GI Steering Committee -Chairpersons -Coop Group
GI Chairs -CTEP -Stats -Lab investigators -R01/SPO
RE investigators -Advocates
TASK FORCES
Esophagogastric
Anal-Rectal
Neuroendocrine
Hepatobiliary
Colon
Pancreas
32
Protocol Development Process in the Public system
Cooperative Group Discussion
Task Force Discussion
Steering Committee Review
33
Question 4
34
Timelines
35
Process Flow Map CALGB(Dilts, Sandler, Baker et
al. JCO, 2006)
36
Calendar Day per Step CALGB(Dilts, Sandler,
Baker et al. JCO, 2006)
37
What can you do to keep the process moving?
  • Get to know the protocol development team
  • Respond rapidly to requests
  • Keep an eye on the process
  • Ask how you can help be proactive
  • Stay in touch with the contract team

38
Barriers to Success of Cooperative Phase III
Trials
  • Note 50 of accrual comes from community
    oncologists the ivory tower does not represent
    reality
  • Cooperative Group studies are not adequately
    reimbursed and cost the investigator money
  • Correlative study participation may not receive
    appropriate credit/reimbursement
  • Competition from industry trials
  • The system is heavily dependent on volunteerism

39
Key Criteria for a Successful Study
  • Keep it simple
  • Ask an important clinical question
  • Ask one clinical question
  • Use a treatment that cant be obtained outside of
    a trial
  • Involve patient advocates in design and beyond
  • Design a marketing strategy early, and implement
    early and often

40
Why conduct cooperative group research?
  • Personal
  • You get to visit cool places and stay in nice
    hotels ...not
  • National platform with thought leaders
  • Access to infrastructure and patient resources
    tissue and data, not merely patients
  • Institutional
  • Cancer Center Support Grant credit
  • Coop Group credits
  • notoriety
  • Societal
  • Address key clinical questions
  • Minimize potential for industry bias in design,
    conduct, reporting
  • Public ownership of data

41
What defines a successful investigator-initiated
study?
  • You got it paid for and done
  • You presented the results and interacted with
    other experts with relevant interests
  • You published the results
  • You addressed an hypothesis
  • You contributed knowledge that leads to further
    exploration
  • You obtained results that will advance cancer
    treatment
  • You enjoyed the experience
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