[Federal Register: August 14, 2007 (Volume 72, Number 156)]
[Notices]
[Page 45433-45434]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14au07-62]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1998D-0077 (formerly 98D-0077)]
Clinical Development Programs for Human Drugs, Biological
Products, and Medical Devices for the Treatment and Prevention of
Osteoarthritis; Request for Assistance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) seeks additional
information on issues related to clinical development programs for
human drugs, biological products, and medical devices for the treatment
and prevention of osteoarthritis (OA). We will take such information
into account as we work to finalize our draft guidance issued in July
1999. Once finalized, the guidance will aid sponsors and other
interested parties in developing new products to treat OA.
Before the agency can issue such guidance, a critical appraisal of
certain fundamentals of the science related to OA is needed. FDA is
inviting any interested party, or parties, to conduct and manage the
coordination of this critical appraisal. FDA believes that the party,
or parties', first step in conducting the critical appraisal would be
to hold a public meeting to discuss issues related to OA assessment and
trial design. FDA intends to submit to the docket all the information
received in response to this notice so that interested parties may be
fully informed and to facilitate participation in and coordination of
these activities.
[[Page 45434]]
DATES: Submit written or electronic comments on this notice by October
15, 2007.
ADDRESSES: Submit written comments on this notice to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Terrie L. Crescenzi, Office of the
Commissioner (HF-18), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-7864.
SUPPLEMENTARY INFORMATION: Because of the positive response to the
agency's guidance on rheumatoid arthritis, the agency has recognized
the need for more information on the development of human drugs,
biological products, and medical devices for the treatment and
prevention of OA. FDA is requesting assistance from the public in
conducting scientific analyses for the purpose of finalizing the
agency's current draft OA guidance.
Specifically, the agency is inviting any interested group or
consortium of interested groups from academia, industry, practitioners,
and patients and their representatives to conduct and manage the
coordination of a critical appraisal of certain fundamentals of the
science related to OA. Initially, the party or parties would organize
and hold a public meeting to discuss relevant questions related to OA
assessment and trial design (a number of which are suggested in this
notice). FDA believes a public meeting will lead to conceptual advances
not now present, and the expression of such advances in a series of
concept papers. These concept papers would then be discussed at
subsequent workshops, soliciting feedback from all parties including
regulators from the United States and elsewhere. Such discussion would
emphasize the rationale for various approaches to key issues.
FDA welcomes other suggestions of activities that could be
undertaken as part of this guidance development effort. To provide a
starting point for discussion, FDA has developed a list of some key
concepts that the interested parties may want to consider for
discussion at the meeting.
1. Should the scope of the guidance apply to OA alone? Are there
particular clinical subgroups of OA that need to be explicitly
considered and addressed?
2. For a claim of symptomatic relief in OA, what are the optimal
outcome measures and trial designs? Currently, withdrawal and flare
designs are commonly used. These designs, while believed to be
predictive, may lack generalizability. It is also difficult to
understand the actual size of the treatment effect based on a flare
design. If withdrawal and flare designs are not optimal, what
alternative designs could be used to support a symptomatic relief
claim? What should the size and duration of exposure of the safety
database be for symptomatic relief?
3. Is a claim of decreased rate of progression useful and, if so,
what would be the appropriate outcome measure(s) to establish the
claim? What is the desirable duration of a trial for this claim? What
comparator arms might be used?
4. For a claim of prevention or risk reduction for the development
of OA, what are potential outcome measures? If biomarkers are used,
what is their state of qualification? What is the desirable duration of
a trial for such a claim? What is an appropriate safety database for a
prevention of OA claim?
5. Are there additional claims that should be considered? If so,
what outcome measures and trial designs should be used?
6. In any long term studies, what are the best statistical
comparisons for inference testing (is, for instance, a comparison of
mean changes from baseline suitable or should responses be graded
according to points on established scales)? Because longer trials
inevitably have substantial dropouts, what imputation methods for
dropouts are most appropriate or should the trial results be based on a
survival analysis or a time to event (for treatment failure) analysis?
Interested persons should submit comments and expressions of
interest in conducting and managing a critical appraisal to the
Division of Dockets Management (see ADDRESSES). Two copies of any
comments are to be submitted, except that individuals may submit one
copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. Received comments are
available for public examination in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: August 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-15844 Filed 8-13-07; 8:45 am]
BILLING CODE 4160-01-S