adaptive response randomization approach can boost patient participation in medical studies -
This is a classic Catch-22: Medical researchers need to understand if a promising new treatment really is better than a current, assigning random half of a group of patients for each treatment.
But when they approach patients to take part in the study, 50-50 random odds don 't seem quite right - and the study struggles to get enough volunteers. This slows efforts to improve the treatment of this condition.
Now new research shows the promise of an approach that takes part of the "random" process, while preserving the ability to compare treatments.
instead of all patients to get treatment chosen at random, the approach adjusts the chances that the study goes. So if the first results show that one of the two treatments seem to work better, the chances of this increase in processing each new patient. He called adaptive or RAR response randomization.
In a new brief report in the journal Stroke , University of Michigan Medical School researchers report the results of how 418 patients Emergency services responded to the two approaches to education medical.
researchers asked the patients to imagine they had just suffered a stroke, they showed a video describing a study that needed to stroke patients, and asked them if they would volunteer for this study if they had really just had a stroke.
that patients did not know is that half of them had been shown a random video describes a classic randomized, and half had seen the same video but with an added section explaining that if the treatment seems to work better in patients earlier, their chances of getting it improve.
Only 54 percent of those shown the first video said they volunteered for the study. But 67 percent of those RAR showed the video said they would register.
If the results play in studies of emergency real time, that difference of 13 points could make a big difference in the pace of medical research, says William Meurer, MD, MS, the doctor of emergency UM who led the study.
"While this is a hypothetical scenario, it shows that we could increase recruitment for the study of acute stroke using an adaptive response randomization design," he said. "This could be particularly important in emergencies, when patients or their relatives have a few minutes to consider the options."
The new study has already led to new research that will focus on understanding the explanation of the patients their chances of getting a treatment over another
.at the same time, a clinical trial network based UM for emergency brain has already started using the RAR approach in some studies. The network, called NETT for neurological tests emergency treatment, is a laboratory for adaptive designs (many using RAR) through a project called Adaptive Designs Accelerate promising trials on treatments (ADAPT-IT).
The main challenge to RAR studies is to ensure that researchers collect sufficient data on each treatment to make their statistical reliability -. that is, to be able to say with certainty that the treatment differences are real and not due to chance
Meurer notes that RAR approach in a study comparing the two treatments can benefit the patients most, but poses a greater challenge for researchers. Using a RAR approach in a study comparing three (or more) options, so that the least effective of the three gets used unless the study is continuing, present an opportunity to improve patient outcomes in the test and learn more effectively.
other adaptive approaches to randomization, as a study of breast cancer where patients are randomized differently depending on the specific characteristics of their cancer, are also beginning to use.
Meurer and UM emergency physician and chair William Barsan NETT, MD, helped colleagues at UM design clinical studies where randomization adapts according to various criteria, including the seriousness of the illness of a patient. They also raised clinical trials researchers what they think of the RAR approach.
Barsan says: "We believe that the use of RAR approach is very attractive in our network, which we treat patients with life-threatening neurological emergencies such as stroke and head trauma . Knowing that more patients receive the most effective treatment seems like the right thing to do. "
Conducting a study RAR no longer requires infrastructure and preparation for researchers, Meurer said - for example, instead of just make up an equal number of treatment packages when the study begins, the research team must prepare a number of packages containing the option that works best increase
It is also important to keep the doctor. " blinded "to which option they give each patient, so they do not bias the study.
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