2010-15814. Issues in the Design and Conduct of Clinical Trials for Antibacterial Drug Development; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in the design and conduct of clinical trials for antibacterial drug development. The public workshop is intended to provide information for and gain perspectives from health care providers, researchers, academia, industry, and regulators on various aspects of design and conduct of clinical trials for antibacterial drugs. The workshop will focus on the design and conduct of non-inferiority (NI) clinical trials, which are often used in the evaluation of the safety and efficacy of a new antibacterial drug. The input from this public workshop will help in developing topics for further discussion.

Date and Time: The public workshop will be held on August 2, 2010, from 8:30 a.m. to 5:30 p.m. and on August 3, 2010, from 8 a.m. to 4 p.m.

Location: The public workshop will be held at the Crowne Plaza Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is limited and available only on a first-come, first-served basis.

Contact Persons: Chris Moser or Lori Benner, Center for Drug Evaluation and Research, Food and Drug Administration, Office of Antimicrobial Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209, Silver Spring, MD 20993-0002, 301-796-1300.

Registration: Registration is free for the public workshop. Interested parties are encouraged to register early because space is limited. Seating will be available on a first-come, first-served basis. To register electronically, e-mail registration information (including name, title, firm name, address, telephone and fax numbers) to [e-mail]. Persons without access to the Internet can call Chris Moser or Lori Benner at 301-796-1300 to register (see Contact Persons). Persons needing a sign language interpreter or other special accommodations should notify Christine Moser or Lori Benner at least 7 days in advance.

SUPPLEMENTARY INFORMATION:

FDA is announcing a public workshop regarding scientific issues in the design and conduct of clinical trials for antibacterial drug development.

Over the past decade, there have been public discussions on NI clinical trial design and the types of infectious disease indications for which the NI clinical trial design is appropriate. This public workshop will provide information on NI trial design, approaches to the justification of NI margins, and the assessment and timing of efficacy endpoints. Challenges in the conduct of clinical trials will be discussed, including good clinical practice and quality system approaches.

The workshop will include presentations and perspectives from FDA and from stakeholders involved in clinical research. The public workshop is intended to provide information for and gain perspective from health care providers, researchers, academia, industry, and regulators on various aspects of the design and conduct of clinical trials for antibacterial drug development. The input from this public workshop will help in developing topics for further discussion.

The agency encourages individuals, patient advocates, industry, consumer groups, health care professionals, researchers, and other interested persons to attend this public workshop.

Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857.

Dated: June 11, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.