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###### Department of Health and Human Services

###### Food and Drug Administration

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

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# 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.
      ( print 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