[Federal Register Volume 76, Number 146 (Friday, July 29, 2011)]
[Notices]
[Pages 45577-45578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19149]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0523]
Clinical Investigator Training Course
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA), Office of Critical
Path Programs and the Clinical Trials Transformation Initiative (CTTI)
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 investigators with expertise in
the design, conduct, and analysis of clinical trials; improve the
[[Page 45578]]
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 7 and
8, 2011, from 8 a.m. to 5 p.m., and on November 9, 2011, from 8 a.m. to
3:30 p.m.
Location: The course will be held at the National Labor College,
10000 New Hampshire Ave., Silver Spring, MD 20903-0002.
Contact Person: Leonard Sacks, Office of Critical Path Programs,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm.
4174, Silver Spring, MD 20993, 301-796-8502.
Registration: Register by October 21, 2011. 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/
information Web site at https://www.trialstransformation.org/fda-clinical-investigator-training-course or by FAX to 919-660-1769. An e-
mail will be sent confirming your registration.
Attendees are responsible for their own accommodations. A block of
rooms has been reserved under ``FDA Clinical Investigator Course'' at
the National Labor College at a reduced conference rate. Reservations
can be made at https://www.supportnlc.org/Room_Reservations.html or by
calling 301-431-6400. FDA has verified the Web site address, but is not
responsible for subsequent changes to the Web site after this document
publishes in the Federal Register.
Registration materials, payment procedures, accommodation
information, and a detailed description of the course can be found at
https://www.trialstransformation.org/fda-clinical-investigator-training-course.
If you need special accommodations due to a disability, please
contact Leonard Sacks at least 7 days in advance. Persons attending the
course are advised that FDA is not responsible for providing access to
electrical outlets.
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 information:
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 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 will comprise
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.
On November 7, 2011, 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. On November 8,
2011, the course will include discussions of scientific, statistical,
ethical, and regulatory aspects of clinical studies. On November 9,
2011, participants will choose among three breakout sessions that
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: July 25, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19149 Filed 7-28-11; 8:45 am]
BILLING CODE 4160-01-P