
[Federal Register: August 21, 2009 (Volume 74, Number 161)]
[Notices]               
[Page 42309-42310]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21au09-59]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0391]

 
Clinical Investigator Training Course

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA's) Office of Critical 
Path Programs and the Clinical Trials Transformation Initiative (CTTI) 
are co-sponsoring a 3-day training course for clinical investigators on 
scientific, ethical, and regulatory aspects of clinical trials. This 
training course is intended to provide 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.

DATES: The training course will be held on November 16 and 17, 2009, 
from 8 a.m. to 5 p.m. and on November 18, 2009, from 8 a.m. to 3:30 
p.m.

ADDRESSES:  The course will be held at the National Labor College, 
10000 New Hampshire Ave., Silver Spring, MD 20903.

FOR FURTHER INFORMATION CONTACT: Devota DeMarco, Office of Critical 
Path Programs (HF-18), Office of the Commissioner, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3605, 
Devota.DeMarco@fda.hhs.gov; or
    Nancy Stanisic, Office of Critical Path Programs (HF-18), Office of 
the Commissioner, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1660, Nancy.Stanisic@fda.hhs.gov.
    Registration: Register by November 2, 2009, at the registration/
information Web site at https://www.trialstransformation.org/fda-
clinical-investigator-training-course/ or by fax at 919-660-1769. 
Registration materials, payment procedures, accommodation information, 
and a detailed description of the course can be found at the 
registration/information Web site. The registration fee is $300 per 
person. The fee includes course materials and onsite lunch. Early 
registration is recommended because seating is limited. There will be 
no onsite registration. If you need special accommodations due to a 
disability, please contact one of the persons listed in the FOR FURTHER 
INFORMATION CONTACT section of this document.

SUPPLEMENTARY INFORMATION:

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 
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 topics:
     The essential toxicological, pharmacological, and 
manufacturing data to support investigational 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:
     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 will comprise 
approximately 26 lectures, each lasting between 30 and 45 minutes. Two 
sessions of case studies will be included for which participants will 
be expected to do preparatory reading and answer questions. The course 
will be presented mainly by senior FDA staff, with guest lecturers 
presenting selected topics.
    On day one, the course will address the role of FDA 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. Presentations will also discuss the role of clinical 
pharmacology in early clinical studies and how this information is used 
in the design of subsequent studies. Day two will include discussions 
of scientific, statistical, ethical, and regulatory aspects of clinical 
studies. Day three will include discussions of safety assessment in 
clinical trials, including hepatic and cardiovascular safety, 
approaches to special populations (e.g., pregnant women and 
pediatrics), and the role of personalized medicine and new scientific 
techniques in medical product development.

[[Page 42310]]

C. Target Audience

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

    Dated: August 14, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20084 Filed 8-20-09; 8:45 am]

BILLING CODE 4160-01-S
