06/07/2010 Jonathan Ratner, Ph.D., Presents Paper at Pharmacoeconomics Meeting
Jonathan Ratner, Ph.D., Presents Paper at Pharmacoeconomics Meeting
Jonathan Ratner, Ph.D., gave a presentation at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 15th Annual International Meeting in Atlanta, Georgia, on May 18, 2010.
Dr. Ratner is a Westat senior economist specializing in health and labor topics.
took part in an ISPOR Issues Panel, Pragmatic Clinical Trials: How Broad Is Too Broad and How Early Is Too Early?
presentation for the panel was titled, Pragmatic Clinical Trials: Health Care Payers' Views of PCT Features and Trade-offs.
Pragmatic clinical trials (PCTs) are a relatively new variant of traditional randomized clinical trials (RCTs).
In an RCT-usually funded by a pharmaceutical manufacturer-researchers test a new drug against a placebo.
The drug manufacturer makes the RCT's results available to the U.S. Food and Drug Administration
(FDA), which approves the new drug for use if convinced that the drug is safe and effective.
"However," Dr. Ratner
explained, "health care payers-private insurers and public payers such as the Defense Department-typically want to know more than what most RCTs tell them.
and a colleague interviewed formulary decisionmakers at private and public payers.
These decisionmakers described their views of PCTs and discussed the trade-offs they would make if cost considerations forced trial sponsors to choose between, for example, a broader patient population and an active (non-placebo) comparator.
preliminary study results are part of a project for a commercial client.