Preceptor

Gregory M. Hicks
Clinical Research Manager

Description

This rotation will involve the investigation of specific phases of clinical research concerning the evaluation of an alternative route of administration for a product currently marketed for control of symptoms related to cancer chemotherapy and AIDS. The proposed new route of administration is currently scheduled to undergo a phase I clinical study during the months of May-Aug 1999. This route may provide a faster onset of action and the ability to titrate doeses as needed.

Students interested in this rotation should first discuss the currenet status of the project with the preceptor in order to assess progress of clinical development.

Objectives

1.	Demonstrate efficient literature search strategies and proficiency in the use of computerized information databases.
2.	Critcally analyze and evaluate literature on the mechanism of action and pharmacokinetic characteristics of the compound under development.
3.	Can analyze/debate areas of current research, specific studies, and future direction of clinical study with this route of administration/class of drugs.
4.	Able to collect the pertinent information necessary to construct a study and/or develop a seminar that addresses a specific problem or current area of interest related to this project.

Requirements and Activities

During the rotation, the resident will be expected to do the following activities:

1.	Students will be expected to devote a minimum of 40 hours per week in attaining the listed objectives. Depending upon circumstances, students may, in general, schedule time a their own discretion. It is anticipated that an 8-1/2 hour day (approximately 8am to 4:30p, M-F) will be expected as a minimum time commitment.
2.	Do extensive reading on current research topics of interest. Journal articles and studies will be assigned for evaluation and critique.
3.	Informal discussions with preceptor on topics of interest.
4.	The student will also udergo an extensive orientation to the organization that will introduce the student to the various facets of the pharmaceutical industry, including clinical investigation, research and development, and interaction with regulatory affairs, sales, marketing, and other areas as applicable.
5.	Present a formal 1 (one)-hour seminar to appropriate staff regarding a topic that will be mutually selected by the student and immediate preceptor. It is anticipated that many of the objectives will be attained during the selection, planning, organization and development of the seminar

Evaluation:

Students will be evaluated on:

1.	Quality of oral and written presentations. Thoroughness, extent of research and preparation, and demonstration of depth of understanding are required criteria.
2.	Discussions with preceptor, in which students are expected to demonstrate understanding of topics encountered during the rotation.
3.	Overall evel of enthusiasm and interest. This can be demonstrated by students willingness and motivation to achieve greater understanding of topics presented or discussed, the quality of student interaction with other associates on a professional level within the organization to achieve mutual goals and attendance.
4.	The ability to act independently without direct day-to-day supervision in order to achieve defined goals.
5.	Seminar presentations. This is a major requirement of the rotation, and will be evaluated in terms of the overall quality of research, organization, and presentation.

Required Readings

Applicable chapters from:

1.	Spilker, B. Guide to Clinical Trial. Philadelphia, PA: Lippincott-Raven; 1996. (Specific chapters will be assigned.)

Additional readings will be provided as a part of the rotation