Date:2009/1/28/(wed) 10:30-12:00

Place:Room Ew-305, E Block,IIS, The University of Tokyo

Speaker:Dr. Jonas Abersbach(Director, SupportLINK Systems Inc./
Research Associate, the Prostate Centre at Vancouver General Hospital)

Title:Tracking and Data Analysis of Multicentre Clinical Trials


Abstract:The pioneering study spearheaded by Dr. Koichiro Akakura when he was
working with Dr. Bruchovsky's group in Vancouver in the early 1990's set the
stage for the worldwide adoption of intermittent androgen suppression for
prostate cancer in today's clinical practice. Dr. Bruchovsky and his
colleagues then started the first prospective clinical trial of intermittent
androgen suppression in 1995. Over the next 6 years, a database of over
200'000 entries was developed from 5000 case report forms. This original
material will be used as a case study of how information from a multicentre
trial was traditionally tracked and analyzed. A number of challenges were
addressed, including the need to ensure consistent data entry and the
detection of errors. Unexpected outcomes required confirmation such as the
relationship between PSA nadir and progression to androgen independence.
Lessons derived from this analysis suggest ways of improving the tracking
and analysis of the data arising from new clinical trials. The enhanced
technology used in the implementation of such trials will be highlighted.