Funding

Osteoarthritis Initiative

Updated July 12, 2001

Osteoarthritis Initiative Public-Private Consortium
Executive Summary

Scientific and clinical experts in the field of osteoarthritis currently perceive that the lack of discrete indicators of disease progression that are acceptable to the U.S. Food and Drug Administration (FDA) as clinical endpoints is a major obstacle to the ability to diagnose, monitor, and treat this degenerative joint disease. The objective of the Osteoarthritis Initiative (OAI) is to pool public and private scientific expertise and funding to collect, analyze, and make widely available the largest research resource to date of clinical data, radiologic information, and biospecimens from individuals with early and progressing OA. The goal is to create a public resource to validate imaging and biochemical biomarkers and ensure that validated biomarkers are made widely available to further drug development and improve the public health.

The OAI is coordinated by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the National Institute on Aging (NIA) and will be managed by NIAMS. It originated from discussions that Dr. Harold Varmus, former Director, NIH, held with industry leadership on exploring ways that the public and private research organizations could work together to improve the efficiency of drug development and clinical trials. Among the suggestions was the creation of clinical research resources such as well defined natural history population cohorts, and biospecimen and bioimaging repositories to facilitate the discovery and evaluation of biomarkers. NIH has led an international planning effort with representatives from 20 private companies, Federal scientists from the NIA, NIAMS, and FDA, academia, and volunteer health organizations. White papers were prepared by experts to evaluate the scientific opportunity for the discovery of osteoarthritis biomarkers and 4 public meetings and workshops were held to develop a research plan.

The result is a general plan for a longitudinal study of approximately 5,000 participants over 5-7 years through the award of NIH peer-reviewed contracts to 4-6 clinical centers and one coordinating center. Members of a Steering Committee will advise on the scientific aspects of the study. Funding will be contributed by both NIH and private sector participants. The private sector funding will consist of equal contributions from Pfizer, GlaxoSmithKline, Merck, and Novartis Pharmaceuticals Corporation. Funding from the NIH is led by NIAMS and NIA with additional contributions from the National Center for Complementary and Alternative Medicine (NCCAM), the National Center for Minority Health and Health Disparities (NCMHD), the National Institute of Dental and Craniofacial Research (NIDCR), the NIH Office of Research on Women's Health (ORWH). The Foundation for the National Institutes of Health (FNIH) is coordinating private sector participation.

One of the most exciting aspects of the OAI is the pooling of private and public funds to create a publicly available scientific and drug discovery resource that would not have been possible by either sector alone. No intellectual property rights in the research resource will accrue to any consortium members. The NIH and other consortium members have determined that widespread availability of validated biomarkers and other research tools arising from use of the OAI resource by third parties is necessary to maximize the public health benefit of the Initiative. Thus, renewable resources arising from the OAI, such as clinical data, x-rays and magnetic resonance images, will be made freely available to qualified scientists everywhere. For OAI resources that are limited, such as the biospecimens, priority will be given to validation of biomarkers that, in addition to demonstrating scientific merit, will be widely available by their owners for internal research and commercial use in accordance with the NIH Principles and Guidelines on Obtaining and Disseminating Biomedical Research Resources.