As OA is a leading cause of disability and the most common chronic condition of the joints, the results of the OA PFDD meeting will provide rationale to accelerate choosing one or more clinical trial endpoints that are clinically meaningful to patients living with OA. Without new scientific discoveries, more and more Americans will be coping with OA. For example, by the year 2030, the rate of knee replacements to treat OA is expected to exceed 3.5 million people per year, with costs exceeding $13 billion annually.
"Patient perspective is critical in helping the FDA ensure that drug development programs capture the efficacy and safety concerns that are most important to the patient," said Guy Eakin, PhD, senior vice president of scientific strategy at the Arthritis Foundation. "The goals of this meeting are to better understand how OA impacts patients, how well current treatments meet patient needs and how they could be better."
Current pharmacological, non-pharmacological and surgical management of OA may alleviate signs and symptoms but don't stop the progression of the disease. In the last decade, substantial advances have been made in understanding the multiple factors, such as past injuries and obesity, that increase risk for OA and how to target structural modification of the OA disease course. It is important that clinical trials for OA include outcomes that reflect clinically meaningful benefits for OA patients including improvements in pain, fatigue and overall functional status.
The meeting is a direct result of the conversation convened during the 2016 Arthritis Foundation – FDA cosponsored Accelerating Osteoarthritis Clinical Trials Workshop, during which regulatory expectations for approval were discussed as well as what approaches could be taken to address them in OA clinical trials.
The Arthritis Foundation is working closely with FDA staff, particularly from the Center for Drug Evaluation and Research's (CDER) Division of Pulmonary, Allergy and Rheumatology Products and Office of Strategic Programs to plan for this meeting.
About the Arthritis Foundation:
The Arthritis Foundation is the Champion of Yes. Leading the fight for the arthritis community, the Foundation helps conquer everyday battles through life-changing information and resources, access to optimal care, advancements in science and community connections. The Arthritis Foundation's goal is to chart a winning course, guiding families in developing personalized plans for living a full life – and making each day another stride toward a cure. The Foundation also publishes Arthritis Today, the award-winning magazine that reaches 4 million readers.
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