[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]]

-----------------------------------------------------------------------

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: [email protected]) 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