Funding

Input from the scientific community gathered in a variety of settings, including interviews, workshops, and conferences, indicated the need to identify biomarkers for the evaluation of OA. A consensus exists that current therapies for OA are palliative, surgical, or pain alleviating modalities and that advances in bone and cartilage biology, provide opportunities for developing disease-modifying therapies. Because of the chronic nature of OA, clinical trials that test interventions that prevent or delay the onset of disease using clinical endpoints are lengthy and require very large numbers of patients.

Characterization of biological factors (biomarkers) of OA (e.g., anatomic characteristics and biochemical parameters) in natural history, population-based observational studies may offer useful measures that accurately predict the course of disease. As valid indicators of disease, biomarkers may serve as candidate surrogate endpoints in clinical trials of novel interventions.

Public health needs and scientific opportunities for OA therapeutic development span the interests of the academic research community, pharmaceutical and biotechnology industries, disease-related advocacy organizations, and regulatory authorities. Recommendations from the scientific community suggest that these organizations explore the use of common resources and mechanisms to conduct investigations that will identify and evaluate biomarkers as candidate surrogate endpoints. To examine options and models for collaborative research, a steering group of interested parties has been formed

Scope Of The Project

The steering group is asked to evaluate currently existing resources and knowledge regarding OA disease markers. They will examine available clinical and laboratory data and specimens from existing natural history and epidemiology studies and clinical trials for applicability to biomarker validation studies. Building on this perspective, the steering group will prioritize research opportunities and needs and recommend a plan to develop and utilize resources for this purpose. The steering group will identify population study design options and recommend technologies to be used, such as medical imaging (radiographic, magnetic resonance, ultrasonography, etc.), biochemical (markers of collagen and bone turnover), and genetic measures. They will also characterize population risk factors, genetic markers, and statistical parameters needed to validate individual or multiple biomarkers as surrogate endpoints. From this evaluation, a prioritized plan with implementation phases will be developed. The steering group will coordinate discussions and options for the support and development of the collaboration. In addition, governance issues, technology transfer policies, intellectual property rights, management of resources, and other administrative oversight provisions will be explored.

Steering Group Representation

Members of the steering group were appointed after consultation with major pharmaceutical and biotechnology industries, professional research organizations, disease advocacy organizations, academic researchers, research agencies, and regulatory authorities. Disciplines and fields represented on the steering group include clinical trial design and practices, orthopedic surgery, clinical and laboratory research, rheumatology, medical imaging, epidemiology, biostatistics, health outcomes research, and research program and regulatory administrators. Federal government organizations represented in the steering group include the National Institutes of Health, U.S. Food & Drug Administration, and National Center for Health Statistics.

Action For Steering Group

The steering group is requested to develop an action plan for the collaboration. Four implementation subcommittees will be organized to address specific areas: 1) epidemiology, biostatistics, and genetics, 2) imaging markers and technologies, 3) biochemical markers, and 4) administration, infrastructure, and management. At its initial meeting, each subcommittee will frame the key questions that need to be addressed at a large open meeting to be held in late 1999/early 2000. Shortly after the open meeting the steering group or subgroup will delineate potential research initiatives that should be undertaken and identify short-, medium- and long term milestones.