Clinical Research Methodology - Clinical Trials Part I"
September 12, 2006
A Presentation by Lance Heilbrun

Clinical trials are the cornerstone of rigorous medical research. In most medical research fields,
especially cancer drug development, there are various phases of clinical trials. Part 1 of this 2-part
lecture will focus on what is probably the most widely known type of clinical trial, the randomized, Phase
III trial. An overview of the basic aspects of the design, ethical aspects, and conduct of a randomized
clinical trial will be described.
This lecture was developed as part of a lecture series on Clinical Trials Methodology for the Wayne
State University (WSU) Department of Internal Medicine trainees (interns, residents, Fellows) and junior
faculty. Accordingly, the statistical level is elementary, although the concepts in clinical trials study
design and conduct are thought provoking, and instructive for anyone without training or experience in
scientific medical research.

Lance Heilbrun is a Professor of Oncology in the Karmanos Cancer Institute at Wayne State University
(WSU), and a Professor of Medicine in the WSU Department of Internal Medicine, Division of
Hematology & Oncology. He has worked in cancer research as a Ph.D. level biostatistician for 30 years.
Dr. Heilbrun has a B.S. in Mathematics from WSU (1969), an M.A. in Mathematical Statistics from WSU
(1971), an M.P.H. in Biostatistics from University of Michigan (UM, 1974), and a Ph.D. in Biostatistics
from UM (1976). He was an Assistant Professor at the M.D. Anderson Cancer Center in Houston (1976-
1979) involved in both local and multi-institutional cancer clinical trials, a Biostatistician at the Japan-
Hawaii Cancer Study in Honolulu (1979-1986) involved in cancer epidemiology, and has been on the
faculty at WSU School of Medicine and in the Karmanos Cancer Institute since 1986. In recent years,
his work has emphasized Phase I and II trials; clinical studies in gastrointestinal, genitourinary, and
gynecologic oncology; and some cancer epidemiology studies.
American Statistical Association
Detroit Chapter Meeting

Lance Heilbrun Lance Heilbrun

Karry Roberts giving Lance Heilbrun a certificate of appreciation from the Detroit chapter