Osteoarthritis Biomarkers

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The goal of the Osteoarthritis Initiative (www.nih/gov/niams/news/oisg/in-dex.htm) is to develop and support clinical research resources that enable discovery, assessment, and validation ofbiomarkers for osteoarthritis. It is a 7-year collaborative project between five pharmaceutical companies—Merck, Pfizer, Novartis, Pharmacia, and GlaxoSmithKline—the Foundation for the NIH, and several NIH institutes. The mechanisms supporting the research infrastructure are shown in Fig. 2. The Foundation for the NIH, established by Congress in 1996 as a 501(c) [3] organization, serves as a nonprofit administrative interface between the government and private industry sponsors. The purpose of the Foundation is to

Figure 2 The Osteoarthritis Initiative project model: financial resource management.

foster collaborative relationships in education, research, and related activities between the NIH, industry, academia, and nonprofit organizations.

The osteoarthritis project anticipates development of biomarkers that include biochemical markers of bone and cartilage, genetic markers associated with osteoarthritis, and structural markers determined using various imaging technologies such as radiographs and magnetic resonance. Funded over a 7-year period at an estimated $60 million, the Initiative anticipates that these biomarkers will provide the nonprofit and commercial scientific communities with new opportunities to develop disease-modifying therapies and streamline clinical trials to assess the safety and efficacy of these therapies. In addition, these resources should facilitate the development of in vitro analytical methods useful in patient diagnosis and management.

Numerous benefits are expected, both for the patient population and for the participants in the Initiative. Development and validation of biomarkers will streamline the clinical trial process and provide incentives for private sector R&D of novel osteoarthritis interventions and in vitro diagnostic products. Moreover, private-sector sponsors may collaborate with academic and NIH scientists in the design of the research plan, the use of research tools, and the management of the consortium and the resources developed by it (Fig. 3). Furthermore, participation by regulatory agencies such as the U.S. FDA will improve communication in the regulatory process. As a consequence, patient care is enhanced through streamlined development of regulatory guidelines, enhanced evaluation of

Figure S The Osteoarthritis Initiative project model: management of data and specimens.

surrogate endpoints in clinical trials, and a more efficient regulatory approval process for new therapies.

The scientific plan was developed in public meetings and includes the following core goals:

Develop a population-based, longitudinal, human subject cohort to characterize the natural history of osteoarthritis.

Apply imaging tools (radiographs and magnetic resonance) to evaluate joint structural markers (principally for the knee joints) as potential surrogate endpoints for clinical trials

Establish biospecimen repositories to enable evaluation of biochemical and genetic markers

In this model, a steering group composed of members from public organizations (NIH and academic investigators), private organizations (sponsoring companies), and liaison representation from the FDA will oversee and provide input to the administration of the research activities. The core units of the research network were recently established. A data-coordinating center established at the University of California, San Francisco will assemble the epidemiological data, track biospecimen and imaging data collection, assemble data and disseminate it among the research community, and coordinate research activities across the network. Four clinical sites, at Ohio State University, University of Rhode Island, University of Pittsburgh, and University of Maryland, serve as the major center for the recruitment of the 5000 research participants. Subcontracts have been issued for support services such as maintaining a biospecimen repository and developing quantitative metrics of the clinical parameters measured in the project. Participating members are also providing information to the research community about how the research resources developed through the consortium will be made publicly available.

Participation in the Consortium will allow integration of data and technology into strategic plans for clinical trials, since validation studies will be conducted with the data and results made available in the public domain. This conserves fiscal and human resources by eliminating the need for multiple private companies to repeat assays and redevelop techniques. By establishing the clinical research resources through this consortium, it is anticipated that private industry sponsors will experience a reduction in development costs and time to evaluate new osteoarthritis therapies.

Several key policies emerged from this model. First, databases developed from the research studies will exist in the public domain, and administrative mechanisms will be implemented to preclude the patenting of the public databases. This will enable academic and commercial research interests to use the knowledge and technology to create new intellectual property without being blocked. Second, in this model, biomarker technology and material rights to such technology can be developed under existing patenting and licensing policies. For example, investigators (public or private) who create new assays or measuring technologies through the use of specimens and data developed by the Initiative retain the ability to commercialize their discovery. A requirement for access to specimens and data will be to present a plan to provide equal access to the resource so as to not block further research or commercial use.

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