Download
a copy of the white paper written by Dr. Alex Dmitrienko, Dr.
Charles Beasley and Dr. Malcolm Mitchell to facilitate an open
discussion of issues related to the design and analysis of thorough
QT studies.
The white paper discusses design and analysis
considerations in thorough QT studies. Section 2 briefly summarizes
main difficulties with the measurement and analysis of QT interval
and provides a high-level description of key features and outcomes
of thorough QT studies. Section 3 reviews design elements that
impact the probability of a negative thorough QT study. Section
4 gives an overview of common approaches to the analysis of QT
interval data collected in these studies that also influence the
probability of a negative outcome.
Readers are encouraged to share their comments,
thoughts and suggestions. Instructions for submitting feedback
can be found on the title page of the white paper.
Comments
submitted by Dr. Scott Patterson (Wyeth).
Comments
submitted by Dr. Arne Ring (Boehringer Ingelheim).
Comments
submitted by Dr. Stan Young (National Institute of Statistical Sciences).
