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," she said.
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 said.