MCLEAN, Va--The way clinical trials are planned and conducted
often means the difference between success and failure in winning
FDA marketing approval for a drug or medical device, industry
leaders said at a conference sponsored by the Cambridge Healthtech
Institute, Waltham, Mass.
Sheila Linder, MD, vice director, international clinical quality
assurance, Hoffmann-La Roche, Ltd., told the audience that most
modern drug development programs are international in nature.
"A global clinical research team responsible for producing
a major NDA within tight deadlines must efficiently make crucial
decisions based on project rationale and target profile,"
Richard Ginsberg, MD, vice president for clinical trials, Roche
Laboratory Corporation of America, Inc., noted that in 1962 an
amendment to the Food and Drug Act was passed requiring "substantial
evidence" of a drug's safety and efficacy for approval.
Since then, he said, the uncertainty and complexity of the clinical
trials required to provide that evidence have increased, as have
the resources and time required to bring a drug to market (an
average of $287 million and 14 years from laboratory synthesis
to the pharmacy shelf).
The number of patients needed to accomplish this has also increased
markedly, and the return on a company's research investment has
decreased because of shortened patent life.
These factors, combined with internal corporate factors such as
uncertain leadership, poor intra- and extramural communications,
and tightening deadlines, make it ever more important to see that
clinical trials are minutely managed at every step, Dr. Ginsberg