Instructor: Irving K. Hwang, Ph.D., Irving
Consulting Group, Pluckemin, New Jersey
Course Outline:
The double-blind placebo-controlled
trials have been the gold standard in
clinical development for many decades. It continues
to provide a useful means to demonstrate the efficacy
of a new test drug in a confirmatory way by showing
its superiority to placebo. With the existence of
drugs of proven efficacy, the conduct of clinical trials
with placebo as the control sometimes posed ethical
dilemma. As more and more effective drugs become
available and less and less breakthrough new drugs
emerge, the objective of clinical investigation amends.
Oftentimes, It seeks non-inferiority/equivalence of the
new drug to an existing effective standard drug in
active controlled trials.
This short course first provides an update on the
development of the ICH E10 guideline: Choice of
Control Group in Clinical Trials and reviews the
crucial issues the E10 guideline intends to convey.
Then, it discusses the design issues in non-inferiority /
equivalence trials that include the choice of
the non-inferiority / equivalence margin, the forms of
the null and alternative hypotheses and confidence
intervals, as well as sample size and power
calculations. Finally, it addresses the inherent
difficulties and some useful design alternatives to the
non-inferiority / equivalence trials.
The focus of this course will be primarily on
statistical concept, reasoning, and practices. General
issues on clinical trial design with special emphasis
on non-inferiority / equivalence trials will be
discussed. Examples for trials in selected therapeutic
areas will
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be given for illustration and exercise
purposes. Appreciation and understanding of these
issues ensure that when a clinical trial with a
properly selected control group is designed and
conducted, it reaches its intended objective(s) with
scientific credibility and regulatory approvability.
New issues emerged at the recent ICH Steering
Committee and E10 Expert Working Group (EWG)
meetings in Japan will also be reviewed.
About the Instructor: Dr. Irving Hwang is
currently President, Irving Consulting Group;
Visiting Professor, Rutgers University; PhRMA
Deputy Topic Leader, ICH E-l0 EWG; and
Pharmaceutical Scientific Advisor, Bureau of
Pharmaceutical Affairs, Rep. of China. Dr. Hwang
has gained over two decades of global drug
development experience with major pharmaceutical
companies in design and analysis of clinical trials for
development of new drugs and vaccines. Dr. Hwang
was Vice President & Head, Global Biometrics,
Hoechst Marion Roussel, Inc. (HMR); Sr. Director,
Clinical Research Operations, Hoechst Roussel
Pharmaceuticals, Inc. (HRPI); and Sr. Director,
Clinical Biostatistics & Research Data Systems,
Merck. He was Member, PhRMA BSS Steering
Committee and Co-Chair, PMA/FDA Workshop on
Clinical Trials Monitoring and Interim Analysis.
Dr. Hwang received his Ph.D. in Statistics from the
Wharton School, University of Pennsylvania. His
research interests include PK/PD modeling,
regression analysis, robust methods, survival
analysis, longitudinal analysis, interim analysis/group
sequential methods, and confirmatory clinical trial
methodology including design and analysis of
landmark megatrials and non-inferiority/equivalence
trials.
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