A new approach to testing medical treatment options could ensure that more patients get the most beneficial treatment for them but still yield valuable research results that stand up to scientific scrutiny.
The approach tries to overcome a huge chicken-and-egg problem in medical research: Not enough people volunteer for studies of new treatments partly because researchers can't promise the studies will help them -- but without enough volunteers, researchers can't study new treatment options.
But a new "adaptive" way of designing medical studies could help. In a recent paper in the Journal of the American Medical Association, and in several clinical trials now being planned at the University of Michigan Health System and partner institutions, adaptive design has come to the fore.
Experts from U-M and other major medical centers say that the approach makes the most sense in situations where time is of the essence such as emergency care or where the medical stakes are high and there are few good treatment options such as some forms of cancer. They also note there are plenty of situations where adaptive design isn't feasible or needed.
But for patients who are being asked to participate in research studies, an adaptive design could help tip the balance between saying yes and saying no. It could also help patients who enter trials have a clearer understanding of what the stakes are for them personally, not just for the generation of patients who will come after them.
"It takes more preparation for the researchers up front, and more sophisticated statistical analysis as the trial is going on, but in the end more study volunteers will be more likely to get the best option for them, and the results will still be scientifically sound," says William Meurer, M.D., a U-M emergency physician who is lead author of the recent JAMA viewpoint article.
The "adaptive" approach to clinical trial design cen
|Contact: Kara Gavin|
University of Michigan Health System