[Federal Register Volume 78, Number 207 (Friday, October 25, 2013)]
[Pages 63988-63989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-25127]



Food and Drug Administration

[Docket No. FDA-2013-N-1214]

Clinical Investigator Training Course

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    The Food and Drug Administration's (FDA's) 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 12 and 
13, 2013, from 8 a.m. to 5 p.m., and on November 14, 2013, 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-
    Registration: Register by November 1, 2013. 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://continuingeducation.dcri.duke.edu/fda-clinical-investigators-training-course-registration or download a full-size copy 
of the registration form from the registration site 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 (see Contact Person) 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 bear the responsibility for 
ensuring the safe and ethical treatment of study subjects and for 
acquiring 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 

[[Page 63989]]

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 use in humans;
     Fundamental issues in the design and conduct of clinical 
     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 accomplish the following:
     Foster a cadre of clinical investigators with knowledge, 
experience, and commitment to investigational medicine;
     Promote communication between clinical investigators and 
     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 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 14, 2013, 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 toward health care professionals responsible 
for, or involved in, the conduct and/or design of clinical trials.

    Dated: October 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25127 Filed 10-24-13; 8:45 am]