[Federal Register Volume 59, Number 198 (Friday, October 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25400]
[[Page Unknown]]
[Federal Register: October 14, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Opportunity for a Cooperative Research
Agreement (CRADA) for the Clinical Evaluation of Magnetic Resonance
Imaging in Breast Cancer
AGENCY: National Institutes of Health, PHS, DHHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Cancer Institute (NCI) seeks major pharmaceutical
companies that can effectively pursue the joint research, development,
evaluation and commercialization of imaging drugs to be used for
magnetic resonance imaging (MRI) in breast cancer. NCI will enter into
CRADA negotiations with the sponsor(s) of the selected proposal(s).
ADDRESSES: Questions about this opportunity may be addressed to Mr.
Eric Hale, Office of Technology Development, National Cancer Institute,
Building 31, Room 4A34, 9000 Rockville Pike, Bethesda, Maryland 20892,
(301) 496-0477.
DATES: Proposals must be received by January 1, 1995.
SUPPLEMENTARY INFORMATION: ``Cooperative Research and Development
Agreement'' or ``CRADA'' means the anticipated joint agreement to be
entered into by NCI pursuant to the Federal Technology Transfer Act of
1986 and Executive Order 12591 of October 10, 1987 to collaborate on
the specific research project described below.
Recent studies reported at the Diagnostic Imaging Research Branch,
Radiation Research Program (DIRB/RRP) workshop indicated that breast
MRI is more sensitive than conventional x-ray mammography in the
detection of early breast cancer. Over the last few years, MRI of the
breast also has emerged as one of the most promising clinical tools for
staging (i.e. definition of multifocal and multicentric lesions) of
breast cancer. Contrast-enhanced MRI has been shown to be a promising
adjunctive diagnostic tool in the following clinical situations: (1)
Failure of conventional mammography and physical examination to provide
diagnosis; (2) detection of small lesions; (3) detection of multifocal
and multicentric breast cancer; (4) breast cancer staging; and (5)
differentiation of dysplasia and scarring versus cancer. While the
sensitivity of breast MRI appears promising, the specificity of this
technique has been reported to be low. However, the recent development
of specialized coils and other equipment for MRI-guided biopsy is
expected to have an important impact on tissue characterization of the
MRI-detected lesions.
DIRB/RRP convened a meeting of the NCI Advisory Group consisting of
leading members of the international academic community and industry in
order to discuss the possibility and feasibility of clinical trials in
breast MRI at this time and to formulate specific clinical questions
that can be answered by such studies. Current results support the
hypothesis that MRI (combined with image-guided biopsy) can improve
early detection and accurate staging of breast cancer. A number of
important clinical issues will be addressed by the clinical trials in
breast MRI anticipated under the CRADA(s), including:
1. Definition of clinical indications for breast MRI studies and
for MRI guided breast biopsy;
2. Definition of clinical indications for breast MRI versus
conventional x-ray mammography and other technologies;
3. Study of the sensitivity and specificity of breast MRI in
patients who will get pathological confirmation (eg., mastectomy,
lumpectomy);
4. Development of a patient follow-up database which would allow
addressing of future clinical issues, such as whether or not breast
MRI can eliminate unnecessary and inappropriate diagnostic and
therapeutic interventions; and
5. Study of the impact of MRI on the cost-effectiveness of
breast cancer management (eg. through possible elimination of
repeated lumpectomies, unnecessary radiation treatment, etc.).
The expected duration of the CRADA is less than or equal to five
(5) years.
The role of the Diagnostic Imaging Research Branch (DIRB) of NCI
under the CRADA(s) will include:
1. The government initiating, coordinating, and sponsoring a
multi-institutional cooperative group involving three to four
institutions for a period of four years;
2. The government supporting and coordinating the development of
experimental study designs;
3. The government supporting and coordinating statistical
analysis on clinical data; and
4. The government overseeing quality assurance for the clinical
trials.
The role of the successful pharmaceutical companies under the
CRADA(s) will include:
1. Providing imaging drugs and corresponding information to be
used in the investigation of their potential use in MRI breast
cancer diagnosis;
2. Providing drug related analytical support that may be
necessary during the course of the clinical trials;
3. Providing access to INDs or NDAs that may need to be cross
referenced;
4. Providing assistance in clinical monitoring and data
management;
5. Providing collaboration in study design and data evaluation;
6. Providing funds for assistance in supporting the clinical
trials (eg. by contributing to the support of the NCI clinical study
sites or supporting additional clinical sites); and
7. Providing for the commercialization of resulting
pharmaceutical products.
Selection criteria for choosing the CRADA partners will include but
not be limited to:
1. Ability to provide investigational drugs at no cost to the
government and necessary support according to an appropriate
timetable to be outlined in the pharmaceutical company's proposal;
2. The level of financial support the pharmaceutical company
will supply for CRADA-related government activities;
3. A willingness to cooperate with the NCI in the collection,
evaluation, publication, and maintenance of data;
4. An agreement to be bound by the DHHS rules involving human
subjects;
5. Experience in clinical drug development;
6. Experience and ability to produce, package, market and
distribute pharmaceutical products in the United States;
7. Experience in the monitoring, evaluation and interpretation
of the data from investigational clinical studies under an IND; and
8. Provisions for equitable distribution of patent rights to any
inventions. Generally, the rights of ownership are retained by the
organization which is the employer of the inventor, with (1) an
irrevocable, nonexclusive, royalty-free license to the government
when a company employee is the sole inventor or (2) the grant of an
option to negotiate an exclusive or a nonexclusive license to the
company when a government employee is the sole inventor.
Dated: October 6, 1994.
Thomas D. Mays,
Director, Office of Technology Development, National Cancer Institute,
National Institutes of Health.
[FR Doc. 94-25400 Filed 10-13-94; 8:45 am]
BILLING CODE 4140-01-P
