Testing of adaptive clinical trial approach gets under way
Pharmaceutical companies and medical device manufacturers are than academic centers to adopt adaptive design for their trials
- Date : 18 Sep 2012
- Topic : Cancer prevention
A new approach for managing clinical trials could ensure that more patients get the most beneficial treatment from studies whose research results can also stand up to scientific scrutiny. The approach tries to overcome a huge 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.
A new "adaptive" way of designing medical studies could help. In a recent paper in the Journal of the American Medical Association (JAMA), 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.
The adaptive approach to clinical trial design centres around how patients are randomly assigned to one of the two or more groups in a study
According to experts from University of Michigan and other major medical centres, the approach makes the most sense in situations where time is of the essence (such as emergency care) or where the medical needs 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 is not feasible or needed.
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.
The adaptive approach to clinical trial design centres around how patients are randomly assigned to one of the two or more groups in a study. In a non-adaptive trial, everyone who volunteers from the first patient to the last gets assigned with what amounts to a coin toss, and the groups end up being of similar size. In an adaptive trial, the trial's statistical algorithm constantly monitors the results from the first volunteers, and looks for any sign that one treatment is better than another. It doesn't tell the patients or the study doctors what they are seeing, but they do start randomly assigning slightly more patients into the group that is getting the treatment that is starting to look better. In other words, the trial "learns" along the way.
By the end of the trial, one of the groups of patients will therefore be larger, which means the statistical analysis of the results will be trickier and the results might be a little less definitive. However, if the number of patients in the trial is large, and if the difference between treatments is sizeable, the results will still have scientific validity.
Pharmaceutical companies and medical device manufacturers have been faster to adopt adaptive design for their trials, but academic centres that conduct huge numbers of non-industry trials have not.
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