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Clinical trials can be improved by managing the learning curve
Date:7/29/2010

ess issues prior to first subject enrollment in a trial. With the use of simulation, just like sports team members, each of the research team members will be able to practice the protocol without involving subjects. Ultimately, we hope to further improve trials through the data obtained in our research studies. "

The study was published in the Quality and Safety in Health Care journal online on July 30.

Co-lead author Mark Stafford-Smith, M.D., a Duke professor of anesthesiology, said that clinical trials that adhere to effective protocols from the very start are beneficial. "In a previous study of critically ill patients, researchers made observations suggesting a benefit for a drug, but the study didn't yield a positive finding, possibly because a learning curve affected early trial data," Stafford-Smith said.

Taekman described the two basic categories of problems with clinical trial protocols problems in educating or training people to run the trial effectively and human-factor problems.

Stafford-Smith said that in one instance a company that was having challenges investigating a new agent came to the Duke Human Simulation and Patient Safety Center to learn how to better conduct a clinical trial. "There was a sense that the drug wasn't working because it was tricky to learn how to use," Stafford-Smith said. A pilot simulation demonstrated potential value as a method for learning how to perform more efficiently during a clinical trial. The company was so impressed that it promptly invested in such training for further investigations of its drug, he said.

"While preparing simulations for the agent, we also uncovered human-factor concerns in the protocols -- issues that made the trial more difficult to conduct," Stafford-Smith said. "The protocols were elegant on paper but flawed in practice that is the human- factor error in a trial." Examples of human-factor problems in trials might be blood tests on patients
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Contact: Mary Jane Gore
mary.gore@duke.edu
919-660-1309
Duke University Medical Center
Source:Eurekalert

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