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Impact of Changing Regulations on Clinical Trials

Johns Hopkins Medical Institutions/ Center for Clinical Trials , Baltimore, Maryland
June 4-5, 1996

Invited Speakers:


Hayden Braine, M.D.
Associate Professor of Oncology and of Medicine
Director, Oncology Hemapheresis

Marie Diener-West, Ph.D.
Associate Professor of Biostatistics and of Ophthalmology

Adele Gilpin, J.D., Ph.D.
Research Associate of Epidemiology

Steven N. Goodman, M.D., Ph.D.
Associate Professor of Oncology Biostatistics

Michael B. Kastan, M.D., Ph.D.
Associate Professor of Oncology and of Pediatrics

Paul S. Lietman, M.D., Ph.D.
Wellcome Professor of Clinical Pharmacology
Professor of Medicine, of Pediatrics and of Pharmacology and Molecular Science

Harry M. Marks, Ph.D.
Assistant Professor of History of Science, Medicine, and Technology


Susan Ellenberg, Ph.D.
Director, Division of Biostatistics and Epidemiology
Food and Drug Administration

Judith Karp, M.D.
Assistant Director for Applied Science
National Cancer Institute

Larry G. Kessler, Sc.D.
Director of the Office of Surveillance and Biometrics
Center for Devices and Radiologic Health
Food and Drug Administration

Janet Keyser
Manager, World Wide Clinical Quality Assurance Resources
Merck & Co., Inc.

David Parkinson, M.D.
Chief, Investigational Drug Branch
National Cancer Institute

This course is part of a continuing series of short courses dealing with the design, conduct, and analysis of clinical trials sponsored by the Johns Hopkins Center for Clinical Trials. It is designed to examine the consequences of regulations on the design and conduct of clinical trials.

The subject matter of this course was of particular interest to our late colleague Brigid Leventhal, M.D., in whose honor we hold this course. Proceeds from the course will support an annual lectureship in her honor.

The topics for discussion will range from issues related to consent and protection of research subjects to more political topics such as required representation. The speakers in the course represent academia, the pharmaceutical industry, government regulatory agencies such as the FDA, and government research organizations such as NIH. This course is intended to attract a multidisciplinary audience of physicians, clinical trial methodologists, policy makers, staff of sponsoring or regulatory agencies, and other health professionals concerned with the design and conduct of clinical trials. The course will consist of a mixture of formal presentations and open discussions that address the following issues:

informed consent and protection of research subjects

quality assurance and monitoring

representation on clinical trials

trial monitoring and safety boards

Copies of lecture materials, a bibliography, and supplemental reading materials will be provided to each course participant.


This course is targeted at those who wish to learn about the impact of recent regulatory changes on the design and conduct of clinical trials; developed mechanisms and practices for coping with new regulations; and cope with the impact of new regulations on clinical investigators, coordinating centers, sponsoring agencies, and the public.

At the conclusion of the course, participants will be more familiar with:

new regulations affecting clinical trials

the historical and legal background for issues such as consents and quality assurance

perspective of various researchers associated with clinical trials regarding regulations

implications of regulations such as inclusion, consent, monitoring, and quality control on the routine design and analysis of clinical trials

Registration :
Registration Fee..... $850
Residents, Fellows and Full Time Students..... $600
(Include letter from department chairperson verifying status.)
*Please note that walk-in registrations will be assessed a $15 charge.

The registration fee, payable in advance, includes instructional materials, continental breakfasts, refreshment breaks, luncheons, and reception and dinner on Tuesday, June 4. Foreign payments must be made on a U.S. bank.

Cancellation Policy: An administrative fee of $35 will be retained on all refunds. Refunds are not possible after the course has begun, and notice of cancellation must be received by the Office of Continuing Medical Education one business day prior to the first day of the course. Refunds will be processed upon receipt of a cancellation letter. The Johns Hopkins University reserves the right to cancel this course at any time. In this event, the full registration fee will be returned to the registrant.

Deadline for Abstracts: na

Email for Requests and Registration: dheaphy@SOM.adm.jhu.edu

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