|Recommendations Accepted to Revamp
NCI Clinical Trials System
The National Cancer Advisory Board (NCAB) of the National
Cancer Institute (NCI) today accepted 22 strategic proposals
for revamping the NCI’s cancer clinical trials system
and a five-year implementation plan to accomplish the
Advances in molecular medicine are the driving force
behind the Clinical Trials Working Group (CTWG) recommendations.
These advances offer enormous potential to improve cancer
clinical practice by advancing beyond the toxic treatments
of the past, but also create new challenges for the
design and conduct of cancer clinical trials.
The new blueprint for the NCI’s clinical trials enterprise
was submitted to the NCAB by the CTWG, a broad-based
group convened in 2004 by NCI Director Andrew von Eschenbach,
M.D., to advise on optimizing the NCI-supported clinical
trials system. By accepting the report, the NCAB endorsed
the CTWG’s recommendations to NCI.
“These recommendations propose integrating the best
of all components of NCI’s clinical trials system into
a cross-disciplinary, coordinated research endeavor
for moving therapies to patients,” said James H. Doroshow,
M.D., director, NCI Division of Cancer Treatment and
Diagnosis, who spearheaded the CTWG. “This new, cooperative
enterprise will be supported by a strengthened scientific
infrastructure and a broadly engaged coalition of critical
Along with Doroshow, CTWG members representing industry,
professional associations, and institutions performing
clinical investigations answered questions for NCAB
members about the proposals, which were presented in
a 77-page report called “Restructuring the National
Cancer Clinical Trials Enterprise.”
“I greatly admire and appreciate the work of the CTWG,” said
von Eschenbach. “This report and its implementation
plan represent a critical step to reaching the NCI goal
of ending the suffering and death due to cancer by 2015.
The recommendations lead to creating a clinical research
infrastructure that will unravel the molecular mysteries
of human cancer and rapidly implement interventions
that will preempt the cancer process.”
“This enormous potential for more specific cancer
treatment, coupled with the complexity of evaluating
new, highly specific agents, requires robust clinical
trial designs,” said Howard Fine, M.D., chief, Neuro-Oncology
Branch, Center for Cancer Research, who co-chaired the
CTWG. “Development of such trials will necessitate comprehensive
information sharing and close collaboration among clinical
researchers and basic and translational scientists as
well as scientists developing modern molecular diagnostic
and imaging techniques.”
The report includes an implementation plan with a timeline
and budget for each initiative, as well as a recommendation
that a formal evaluation system be developed to assess
the success of the restructuring effort over time.
The CTWG initiatives are organized into five categories,
and in each section, the initiatives are organized into
two types. New initiatives propose fundamental and significant
changes in the operation of the NCI clinical trials
system. Enhancement initiatives propose expansion or
enhancement of activities already underway within NCI.
Listed below are the five categories, with new initiatives
shown in italics.
- Create a comprehensive database containing information
on all NCI-funded clinical trials to facilitate better
planning and management across clinical trial venues.
- Realign NCI and academic incentives to promote collaborative
- Increase cooperation between NCI, the U.S. Food
and Drug Administration (FDA), and industry to enhance
the focus and efficiency of oncology drug development.
- Expand awareness of the NCI-FDA expedited approval
process to speed trial initiation.
- Work with the Centers for Medicare and Medicaid
Services (CMS) to identify clinical studies that address
both NCI and CMS objectives, and for which CMS may
be able to reimburse some routine and investigational
Prioritization/Scientific Quality Initiatives
- Create an Investigational Drug Steering Committee
to work with NCI to enhance the design and prioritization
of early-phase drug development trials.
- Create a network of Scientific Steering Committees,
which leverage current Intergroup, Cooperative Group,
Specialized Programs of Research Excellence (SPORE),
and Cancer Center structures, to work with NCI in
the design and prioritization of phase III trials
to better allocate scarce resources, improve scientific
quality, and reduce duplication.
- Increase community oncologist and patient advocate
involvement in clinical trial design and prioritization
to improve the rate of patient accrual, and better
address practical and quality of life concerns in
the design of trials.
- Develop a funding and prioritization process to
ensure that critical correlative science and quality
of life studies can be conducted in a timely manner
in association with clinical trials.
- Develop a standards-setting process for the measurement,
analysis, and reporting of biomarker data in association
with clinical trials to enhance data comparisons,
reduce duplication, and facilitate data submission
for regulatory approval.
- Investigate integration of phase II trials into
the overall prioritization process to further coordinate
the national clinical trials system.
- Create, in partnership with the extramural cancer
research community, a national cancer clinical trials
information technology infrastructure fully interoperable
with NCI’s cancer Bioinformatics Grid to improve cost
effectiveness and comparability of results across
trials and sites.
- In consultation with industry and FDA, develop standard
case report forms incorporating common data elements
to improve information sharing among cancer researchers
and to optimize data requirements.
- Build a credentialing system for investigators and
sites recognized by NCI and industry to allow faster
trial initiation and keep the investigative community
abreast of legal, safety, and regulatory changes.
- Develop commonly accepted clauses for clinical trial
contracts with industry to reduce the lead-time needed
to open trials.
Operational Efficiency Initiatives
- Restructure the phase III funding model to promote
rapid patient accrual rates and cost-effectiveness.
- Reduce institutional barriers to timely trial initiation.
- Increase patient and public awareness and understanding
of clinical trials.
- Increase minority patient access to clinical trials
to improve the participation of underserved and underrepresented
- Promote adoption of the NCI Central Institutional
Review Board facilitated review process to reduce
the time and resources needed to open trials at individual
- Create a Clinical Trials Oversight Subcommittee
of the NCAB to advise the NCI director on conduct
of clinical trials across the institute.
- Develop a coordinated NCI organizational structure
to manage the entire clinical trials enterprise supported
by the institute.
More information about the CTWG and the full report
can be found at: http://integratedtrials.nci.nih.gov.
The National Cancer Advisory Board is an oversight
group that makes recommendations to NCI.
NCI is part of the National Institutes of Health
(NIH), the biomedical research arm of the federal
government. NIH is an agency of the U.S. Department
of Health and Human Services.