[Federal Register Volume 64, Number 250 (Thursday, December 30, 1999)]
[Notices]
[Page 73566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33909]
[[Page 73566]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin
Diseases; Notice of Meeting of the Osteoarthritis Initiative--A Public-
private Research Collaboration
Notice is hereby given of the Meeting The Osteoarthritis
Initiative--A Public-Private Research Collaboration, February 28-29,
2000, to be held at the Lister Hill Auditorium, NIH Campus, Bethesda,
Maryland 20892 This meeting will be open to the public from 8 a.m. to 5
p.m. on both days.
This meeting is being organized by several NIH Institutes and
Centers, the FDA, and numerous pharmaceutical and biotechnology
companies who have formed a consortium to develop and support a project
that will enhance and facilitate the development of clinical
interventions for osteoarthritis. The development and testing of
treatments for osteoarthritis through clinical trials are now limited
because good biological markers to serve as surrogates for disease
endpoints are not available. This consortium was formed in response to
a 1998, NIH-wide initiative from Dr. Harold Varmus to foster
investigations that utilize fundamental knowledge and laboratory
technologies to develop surrogate biomarkers of disease. In all areas
of medicine there has been an enormous growth in the identification of
potential targets for disease modification. Without the tools for rapid
and inexpensive testing of potential targets, the development of new
drugs will continue to be limited. Osteoarthritis presents great
scientific opportunity and public need.
The consortium that has resulted from meetings of an Osteoarthritis
Initiative Steering Group is exploring the options for government and
industry to cosponsor, as a public-private consortium, the
establishment of a research infrastructure to develop and evaluate
biomarkers for osteoarthritis. Summaries of the meetings held can be
found at http://www.nih.gov/niams/news/oisg/index.htm.
The overall scientific goal of the OA Initiative is to examine the
progressive development of OA through the support of an
epidemiological, human cohort prospective study with the following
aims:
Identifying specific quantitative surrogate markers of OA
disease which can be used to monitor disease progression and response
to therapy and become acceptable as registrable end points in clinical
studies evaluating disease modifying agents;
Enabling more efficient and effective clinical trials and
a better understanding of the causative pathological mechanisms
responsible in the development and progression of the OA disease;
Initiating a new paradigm in which registrable clinical
endpoints are established in non-interventional studies; and
Establishing the managerial framework for similar Public/
Private Partnerships in other disease areas.
The broad questions stated below represent starting points for the
discussion of the scientific plan at and following the OA Initiative
Meeting February 28-29, 2000:
Are structural (anatomic) features of the joint (hip,
knee, and hand) and associated tissue, such as joint space narrowing
and osteophyte development, reliable markers of disease and disease
progression?
Are there biochemical or biophysical markers that would
allow assessment of response to disease-modifying therapies?
What research tools, resources, and knowledge are needed
to develop reliable biomarkers of OA that may serve as surrogate
endpoints in clinical trials?
The February 28-29, 2000 meeting will focus on the development of a
strategic plan for the Osteoarthritis Initiative. Input from the
scientific community to this strategic plan based on the questions
stated above is invited and welcomed.
Ms. Maureen Knowles (NIAMS; Extramural Program; Natcher building;
Room 5As-43; Bethesda, MD 20892-6500; Phone: 301-594-5055, Fax: 301-
480-4543, e-mail: mk92w@nih.gov) will provide further information or it
can be accessed at the following Web site
http://www.nih.gov/niams/news/currmeetregmat.htm.
Individuals who plan to attend and need special assistance, such as
sign language interpretation or other reasonable accommodations, should
contact Ms. Knowles at 301-594-5055, in advance of the meeting.
Dated: December 20, 1999.
Ruth L. Kirschstein,
Deputy Director, National Institutes of Health.
[FR Doc. 99-33909 Filed 12-29-99; 8:45 am]
BILLING CODE 4140-01-M
