2012 EDUCATIONAL BOOK - American Society of Clinical Oncology

NCI NATIONAL CLINICAL TRIALS NETWORK
main areas of support from NCTN and NCI: (1) clinical trial
access, (2) group participation, (3) operation and regulatory
standardization, (4) patient recruitment enhancement, and
(5) adequate funding and support (Table 5). However, the
new proposed network poses both old and new challenges,
including NCTN membership issues, site trial portfolio
management, volunteer investigator time, and funding in a
time of stagnant and diminishing government resources
(Table 6).
The new NCI NCTN offers the promise of a more efficient
clinical trials system that will translate the rapidly expand-
Author’s Disclosure of Potential Conflicts of Interest
Author
Stephen S. Grubbs*
Table 1. IOM Committee Recommendations
Goal I. Improve the speed and efficiency of the design, launch, and conduct of
clinical trials.
§ Review and consolidate some front-office operations of the cooperative groups
on the basis of peer review.
§ Consolidate back-office operations and improve processes.
§ Streamline and harmonize government oversight.
§ Improve collaboration among stakeholders.
Goal II. Incorporate innovative science and trial design into cancer clinical trials.
§ Support and use biorepositories.
§ Develop and evaluate novel trial designs.
§ Develop standards for new technologies.
Goal III. Improve the means of prioritization, selection, support, and completion of
cancer clinical trials.
§ Reevaluate the National Cancer Institute’s role in the clinical trials system.
§ Increase the accrual volume, diversity, and speed of clinical trials.
§ Increase funding for the cooperative group program.
Goal IV. Incentivize the participation of patients and physicians in clinical trials.
§ Support clinical investigators.
§ Cover the cost of patient care in clinical trials.
Table 2. National Cancer Institute Clinical Trials Network
Transformation Goals
§ Prioritize molecular characterization resources and develop molecularly driven
trial design.
§ Improve prioritization of phase III portfolio across disease entities.
§ Remove disincentives to study less common diseases.
§ Create a shared IT structure.
§ Harmonize procedures.
§ Integrate imaging technology.
§ Integrate national tissue banking resources.
§ Grant open access to the network for clinical and transitional investigations.
Table 3. Adult Cooperative Group Consolidation
● American College of Surgeons Oncology Group, Cancer and Leukemia Group B,
North Central Cancer Treatment Group (Alliance for Clinical Trials in Oncology)
● Gynecologic Oncology Group, National Surgical Adjuvant Breast and Bowel
Project, Radiation Therapy Oncology Group (Neuroinformatics Research Group
[NRG] Oncology)
● American College of Radiology’s Imaging Network, Eastern Cooperative
Oncology Group
● Southwest Oncology Group
*No relevant relationships to disclose.
Employment or
Leadership
Positions
Consultant or
Advisory Role
ing scientific knowledge of cancer to practice and provide
our patients and their families with innovative cancer management
strategies in a more timely fashion. Surely our
community clinical investigators will embrace NCTN and
contribute to its success.
Stock
Ownership Honoraria
Table 4. National Clinical Trials Network Group Review
and Funding
§ Modified U10 program
§ Increased per case reimbursement for high accruing sites
§ National Cancer Institute (NCI) external peer review of groups in the same
review cycle
§ New review criteria to include evaluation of collaboration within the network and
other NCI-funded programs (e.g., Specialized Programs of Research Excellence),
operational efficiency, and overall scientific quality.
Table 5. Community Clinical Trial Site Desirables
I. Clinical Trial Access
§ Phase II and III treatment trials
§ Cancer control and prevention trials
§ Comparative effectiveness trials
§ Innovative scientific questions
§ Common diseases and expanded performance status eligibility
II. Group Participation
§ Group identity
§ Interaction with academic colleagues
§ Leadership opportunities in both scientific and operation activities
§ Publication authorships
§ Professional recognition
III. Operational and Regulatory Standardization
§ Common protocol templates and data submission
§ Consolidated audit system
§ Regulatory burden easement
IV. Patient Recruitment Enhancement
§ Electronic health record cues
§ Clinical trial marketing to the public
§ Underserved community accrual
V. Adequate Funding
§ Reimbursement for actual cost
Table 6. Community Clinical Trial Site Challenges
I. Network Membership
§ High volume sites versus broad membership inclusion
§ Single versus multiple group membership
§ Trial accrual credit assignment
II. Site Trial Portfolio Management
§ Access to all four groups’ trials
§ Orphan or less common disease trial resource allocation
II. Volunteer Investigator Time
§ Engagement
§ Promotion
§ Value
III. Reimbursement
§ Tiered per case reimbursement
§ Anticipated static or decreasing National Cancer Institute budget
Research
Funding
Expert
Testimony
Other
Remuneration
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