
[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Notices]
[Pages 60440-60441]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24214]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Clinical Investigator Training Course

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA) Center for Drug 
Evaluation and Research/Office of Medical Policy and the Duke 
University Office of Continuing Medical Education are cosponsoring a 3-
day training course for clinical investigators on scientific, ethical, 
and regulatory aspects of clinical trials. This training course is 
intended to provide clinical investigators with expertise in the 
design, conduct, and analysis of clinical trials; improve the quality 
of clinical trials; and enhance the safety of trial participants. 
Senior FDA staff will communicate directly with clinical investigators 
on issues of greatest importance for successful clinical research.
    Date and Time: The training course will be held on November 13 and 
14, 2012, from 8 a.m. to 5 p.m., and on November 15, 2012, from 8 a.m. 
to 4 p.m.
    Location: The course will be held at the Holiday Inn College Park, 
10000 Baltimore Ave., College Park, MD 20740.
    Contact Person: Connie Wisner, Office of Medical Policy, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6360, Silver Spring, MD 20993, 301-796-
8509.
    Registration: Register by October 22, 2012. The registration fee is 
$400 per person. The fee includes course materials and onsite lunch. 
Early registration is recommended because seating is limited. There 
will be no onsite registration.
    Register online for the training course at the registration Web 
site: http://evm.auxserv.duke.edu/iebms/reg/reg_p1_form.aspx?oc=10&ct=DCRIINVEST&eventid=46475 or download a full-size 
copy of the registration form and mail a check and completed form to: 
Duke University Conference and Event Services, FDA Investigator Course 
Box 90841, 101 Bryan Center, Durham, NC 27708. You will receive an 
email that confirms your registration. (FDA has verified the Web site 
address, but FDA is not responsible for subsequent changes to the Web 
site after this document publishes in the Federal Register.)
    Attendees are responsible for their own accommodations. A block of 
rooms has been reserved under ``FDA Clinical Investigator Course'' at 
the Holiday Inn College Park at a reduced conference rate. Reservations 
for these accommodations can be made online using the course 
registration Web site mentioned previously. Click on ``registration 
form.'' You will see a direct link to the hotel.
    Registration materials, payment procedures, accommodation 
information, and a detailed description of the course can be found at 
the registration/information Web site mentioned previously.
    If you need special accommodations due to a disability, please 
contact Connie Wisner at least 7 days in advance. Persons attending the 
course are advised that FDA is not responsible for providing access to 
electrical outlets.

I. Background

    Clinical trial investigators play a critical role in the 
development of medical products. They are responsible for ensuring the 
safe and ethical treatment of study subjects and for collecting 
adequate and reliable data to support regulatory decisions. This course 
is intended to assist clinical investigators in understanding what 
preclinical and clinical information is needed to support the 
investigational use of medical products, as well as the scientific, 
regulatory, and ethical considerations involved in the conduct of 
clinical trials. The course will cover a wide variety of key topics, 
including material on novel safety concerns, adverse event monitoring, 
compliance with the legal and ethical obligations of clinical research, 
and acceptable scientific and analytic standards in the design and 
conduct of clinical studies. The faculty will include a diverse 
representation of senior FDA staff, enabling FDA to communicate 
directly with clinical investigators on issues of greatest importance 
for successful clinical research.

II. Description of the Training Course

A. Purpose

    The training course is designed to provide clinical investigators 
with an overview of the following information:
     The essential toxicological, pharmacological, and 
manufacturing data to support investigational drug use in humans;
     Fundamental issues in the design and conduct of clinical 
trials;
     Statistical and analytic considerations in the 
interpretation of trial data;
     Appropriate safety evaluation during studies; and
     The ethical considerations and regulatory requirements for 
clinical trials.
    In addition, the course should do the following:
     Foster a cadre of clinical investigators with knowledge, 
experience, and commitment to investigational medicine;
     Promote communication between clinical investigators and 
FDA;
     Enhance investigators' understanding of FDA's role in 
experimental medicine; and
     Improve the quality of data while enhancing subject 
protection in the performance of clinical trials.

B. Proposed Agenda

    The course will be conducted over 3 days and comprised of 
approximately 26 lectures, each lasting between 30 and

[[Page 60441]]

45 minutes. The course will be presented mainly by senior FDA staff, 
with guest lecturers presenting selected topics.
    The course will address FDA's role in clinical studies, regulatory 
considerations for clinical trials, and review of the material 
generally appearing in an ``investigator's brochure,'' i.e., the 
preclinical information (toxicology, animal studies, and chemistry/
manufacturing information) that supports initial clinical trials in 
humans. Presenters will discuss the role of clinical pharmacology in 
early clinical studies and how this information is used in the design 
of subsequent studies. The course will also include discussions of 
scientific, statistical, ethical, and regulatory aspects of clinical 
studies. On November 15, 2012, participants will choose among three 
breakout sessions that will explain how to put together an application 
to FDA for drugs, biologics, or devices.

C. Target Audience

    The course is targeted at health care professionals responsible 
for, or involved in, the conduct and/or design of clinical trials.

    Dated: September 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24214 Filed 10-2-12; 8:45 am]
BILLING CODE 4160-01-P


