81 FR 5467 - The Arthritis Foundation-Food and Drug Administration Accelerating Osteoarthritis Clinical Trials Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 21 (February 2, 2016)

Osteoarthritis is the most common form of arthritis, and occurs when the cartilage that cushions the bones of the joint break down and the bones begin to rub together. This can cause pain, swelling, and loss of motion of the joint. The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in co- sponsorship with the Arthritis Foundation is announcing a workshop entitled, ``Accelerating OA Clinical Trials Workshop''. The purpose of the workshop is to discuss recommendations from the international Arthritis Foundation Accelerating Osteoarthritis Clinical Trial workgroup and identify next steps in forging new approaches to osteoarthritis clinical trials that may improve the likelihood of successful conduct and outcomes of these trials and lead to the development of safe and effective treatments for osteoarthritis.

[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)]
[Notices]
[Pages 5467-5468]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01789]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


The Arthritis Foundation--Food and Drug Administration 
Accelerating Osteoarthritis Clinical Trials Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of workshop.

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SUMMARY: Osteoarthritis is the most common form of arthritis, and 
occurs when the cartilage that cushions the bones of the joint break 
down and the bones begin to rub together. This can cause pain, 
swelling, and loss of motion of the joint. The Food and Drug 
Administration's (FDA) Center for Drug Evaluation and Research, in co-
sponsorship with the Arthritis Foundation is announcing a workshop 
entitled, ``Accelerating OA Clinical Trials Workshop''. The purpose of 
the workshop is to discuss recommendations from the international 
Arthritis Foundation Accelerating Osteoarthritis Clinical Trial 
workgroup and identify next steps in forging new approaches to 
osteoarthritis clinical trials that may improve the likelihood of 
successful conduct and outcomes of these trials and lead to the 
development of safe and effective treatments for osteoarthritis.

DATES: The workshop will be held on February 24, 2016, from 8 a.m. to 
5:30 p.m., and February 25, 2016, from 8 a.m. to 2 p.m.

ADDRESSES: The workshop will be held at the Atlanta Airport Hilton, 
1031 Virginia Ave., Atlanta, GA 30354.

FOR FURTHER INFORMATION CONTACT: Sarah Yim, Office of New Drugs, Center 
for Drug Evaluation and Research, email: [email protected]; Amanda 
Niskar, Arthritis Foundation, Inc., 1330 West Peachtree St., Atlanta, 
GA 30309, 404-964-7545, FAX: 404-965-7807, email: 
[email protected]; or Becky Bosworth, Arthritis Foundation, Inc., 
1330 West Peachtree St., Atlanta, GA 30309, 404-965-7673, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The osteoarthritis (OA) community of clinicians, physicians and 
scientists have been challenged to get new treatments to market so that 
people with OA can benefit at the point of care. The Arthritis 
Foundation and FDA are convening experts to discuss alternative 
approaches to clinical trials in OA.

[[Page 5468]]

Workshop objectives will include discussion and identification of 
promising innovations that could facilitate successful trials in OA, 
new approaches to recruitment for clinical trials, feasible and 
clinically meaningful trial endpoints, and approaches for reducing the 
time and cost of OA trials while maximizing the likelihood of success.
    Registration: There is no fee to attend the workshop, but attendees 
must register in advance. Space is very limited. Persons interested in 
attending this workshop may request to register by sending their resume 
and inquiry to [email protected]. The registration deadline is 
February 2, 2016.

II. Accommodations

    An online registration link and a meeting code will be provided 
through the registration process giving participants a reduced group 
rate for hotel accomodations, not including applicable taxes. No 
additional reservations are required. Industry and government attendees 
are responsible for the cost of their own accomodations. If you need 
special accommodations due to a disability, please contact Becky 
Bosworth at [email protected] at least 7 days in advance.

III. Transcripts

    No transcripts will be available from the event, however, the event 
will be video taped for the purposes of the Arthritis Foundation. 
Speaker presentation materials, if permitted by the presenter, will be 
available on the Arthritis Foundation Web site following the workshop.

     Dated: January 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01789 Filed 2-1-16; 8:45 am]
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