Making Progress: Arthritis Foundation and FDA Meet to Make a Difference for Those with OA
With several years gone by since the last drug for
osteoarthritis (OA)
was approved, the 27 million Americans with OA are ready to hear Yes when it comes to new therapies and diagnostic tests for OA.
Fortunately, this past May, Arthritis Foundation met with Janet Woodcock, the Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) and her colleagues. A representative from the Center for Biologics Evaluation and Research (CBER) also attended the meeting. The goal of the meeting was to discuss how the organizations can work together to design and implement new approaches to clinical trials that will accelerate the improvement of health outcomes for people with OA.
“Our common ground is that we want to get new and successful diagnostics and treatments to the point of care where people with OA can benefit from recent scientific discoveries,” says Arthritis Foundation National Scientific Director Amanda Niskar. “Our goal is for clinical trials to take five years or less, to be less costly and to produce reliable, valuable results everyone can believe in.”
According to Niskar, clinical diagnostics and treatments for OA need to be strengthened.
“Our first challenge is to have qualified diagnostics because right now, we have a lot of people who have OA but are not being diagnosed or who do not have OA, but are being told they do,” says Niskar. “If we don’t have the right diagnostics, whether biochemical, biophysical or patient-reported, we can’t get to the important work of creating and validating new treatments.”
While there currently are therapies for OA, most of them only treat symptoms of the disease rather than slowing or even reversing damage. For some people, the current therapies don’t work at all, or they cause intolerable side effects.
“Many people with OA are not getting enough relief from the current treatments available,” says Niskar. “Even for people who do find relief, it’s often not permanent. With the current treatments, people are able to retain some functionality so that they can take care of themselves, but they still might not get enough relief to work in a preferred profession or to do things they’re passionate about. We aim to change that.”
One of the outcomes of the meeting was that the FDA assigned the Arthritis Foundation two representatives -- one to provide guidance to the Arthritis Foundation regarding the process of biomarker qualification and one to participate in the Accelerating OA Clinical Trials Workshop Planning Committee and Workgroup.
“We’re excited to be putting our heads together with this incredibly talented group of clinicians, scientists and leaders,” says Ann Palmer, president and CEO of the Arthritis Foundation. “We’re hopeful that this will lead to scientific discovery and greater access to diagnostic tools and therapies for OA. For the millions of Americans with OA, the best is yet to come.”
Those in attendance representing the Arthritis Foundation included: Arthritis Foundation President and Chief Executive Officer Ann Palmer, Arthritis Foundation National Scientific Director Amanda Niskar and Arthritis Foundation National Board Member and Osteoarthritis Research Society International President Virginia Kraus. Christian Latterman, MD, an Arthritis Foundation research grant awardee and director of the Center for Cartilage Repair and Restoration at the University of Kentucky and Steven Svoboda, MD Arthritis Foundation science department volunteer and sports medicine fellowship director and team physician also attended on behalf of the Arthritis Foundation.
Get more information about the Arthritis Foundation’s path to a cure.
Fortunately, this past May, Arthritis Foundation met with Janet Woodcock, the Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) and her colleagues. A representative from the Center for Biologics Evaluation and Research (CBER) also attended the meeting. The goal of the meeting was to discuss how the organizations can work together to design and implement new approaches to clinical trials that will accelerate the improvement of health outcomes for people with OA.
“Our common ground is that we want to get new and successful diagnostics and treatments to the point of care where people with OA can benefit from recent scientific discoveries,” says Arthritis Foundation National Scientific Director Amanda Niskar. “Our goal is for clinical trials to take five years or less, to be less costly and to produce reliable, valuable results everyone can believe in.”
According to Niskar, clinical diagnostics and treatments for OA need to be strengthened.
“Our first challenge is to have qualified diagnostics because right now, we have a lot of people who have OA but are not being diagnosed or who do not have OA, but are being told they do,” says Niskar. “If we don’t have the right diagnostics, whether biochemical, biophysical or patient-reported, we can’t get to the important work of creating and validating new treatments.”
While there currently are therapies for OA, most of them only treat symptoms of the disease rather than slowing or even reversing damage. For some people, the current therapies don’t work at all, or they cause intolerable side effects.
“Many people with OA are not getting enough relief from the current treatments available,” says Niskar. “Even for people who do find relief, it’s often not permanent. With the current treatments, people are able to retain some functionality so that they can take care of themselves, but they still might not get enough relief to work in a preferred profession or to do things they’re passionate about. We aim to change that.”
One of the outcomes of the meeting was that the FDA assigned the Arthritis Foundation two representatives -- one to provide guidance to the Arthritis Foundation regarding the process of biomarker qualification and one to participate in the Accelerating OA Clinical Trials Workshop Planning Committee and Workgroup.
“We’re excited to be putting our heads together with this incredibly talented group of clinicians, scientists and leaders,” says Ann Palmer, president and CEO of the Arthritis Foundation. “We’re hopeful that this will lead to scientific discovery and greater access to diagnostic tools and therapies for OA. For the millions of Americans with OA, the best is yet to come.”
Those in attendance representing the Arthritis Foundation included: Arthritis Foundation President and Chief Executive Officer Ann Palmer, Arthritis Foundation National Scientific Director Amanda Niskar and Arthritis Foundation National Board Member and Osteoarthritis Research Society International President Virginia Kraus. Christian Latterman, MD, an Arthritis Foundation research grant awardee and director of the Center for Cartilage Repair and Restoration at the University of Kentucky and Steven Svoboda, MD Arthritis Foundation science department volunteer and sports medicine fellowship director and team physician also attended on behalf of the Arthritis Foundation.
Get more information about the Arthritis Foundation’s path to a cure.
