Framework for Evaluating Trial Results Detailed

With thousands of clinical trials in play, many oncology specialists are reluctant to embrace findings from newly-released studies that would change the way they practice medicine. Laura Esserman, MD, MBA, a professor of surgery and radiology at the University of California, San Francisco, recommends that clinicians form a framework for evaluating the results of clinical trials as a method of deciding how they will react.

"This is a very thorny issue and it's very hotly debated," Esserman said during a presentation at the Miami Breast Cancer Conference Saturday.

She said there are a variety of reasons that clinicians hesitate to change their practices because of a study, including skepticism about the results and the burden that adopting new technology may represent.

Esserman, who also is director of the Carol Franc Buck Breast Cancer Center, suggested clinicians consider these questions about a given trial:

• Do similar trials support the results?
• Are more trials pending?
• What is the cost of adopting a new approach?
• What is the cost in terms of lost opportunity of not adopting an approach?

She has developed a model of evaluating new approaches that takes into account the quality-adjusted life years and the incremental cost effectiveness.

"The likelihood that the trial results will change practice can be estimated and modeled, and provide practitioners and patients with a more rational basis for making a decision about the early adoption of results” said Esserman.