Research Methodology - Clinical Trials Part II"
October 10, 2006
A Presentation by Lance Heilbrun
Clinical trials are the
cornerstone of rigorous medical research. In most medical research
especially cancer drug development, there are various phases of
clinical trials. Part 1 of this 2-part
lecture focused on what is probably the most widely known type of
clinical trial, the randomized, Phase
III trial. Part 2 will focus on the lesser known Phase I and Phase II
trials, and briefly cover some
specialized types of randomized trials (crossover, equivalence, and
cluster trials). An overview of the
basic aspects of the design, ethics, and conduct of Phase I and Phase
II clinical trials will be given.
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
Karry Roberts giving
a Certificate of Appreciation from the Detroit Chapter