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University of Michigan Health System

Health Care

University of Michigan to Study Adaptive Clinical Trials

Adaptive design allows statisticians to continuously reanalyze data over an entire study

Published: Thursday, October 21, 2010 - 15:43

William Barsan, M.D., chair and director of the U-M Department of Emergency Medicine.

(University of Michigan: Ann Arbor, MI) -- Clinical trials in which participants are randomly assigned to different treatments by design are the cornerstone of clinical research. When conducted correctly, it's widely accepted by the research community that the results are valid and can be trusted.

But by investigating the effect of a class of innovative trial designs known as "adaptive clinical trials," researchers at the University of Michigan Health System hope to improve the process for bringing therapies and medical devices to patients. Adaptive clinical trials make adjustments to the trials based on information accumulated as patients are enrolled; the theory is that this process will improve the efficiency of clinical trials as a whole.

"One of the hard-and-firm rules of randomized clinical trials, and for good reason, is you can't just go changing your trial to get the results you want," says Dr. William Barsan, chair and director of the University of Michigan's Department of Emergency Medicine. "But with adaptive clinical trials, you spend a lot of time up front asking yourself, 'What if?' so that any changes made throughout the study are all agreed upon at the beginning, written into the study design, and only changed during the course of the study based on prespecified rules."

Researchers can't always predict at what point a specific drug or treatment will show therapeutic results during the course of the study, if at all. Once a standard trial is underway, trial characteristics such as inclusion criteria cannot be modified or changed even if a sufficient amount of data collected before the trials end-date demonstrates that such changes may be necessary.

For example, remaining patients who are randomized to the placebo group cannot benefit from the therapeutic effect of the treatment, and money will continue to be spent until the trial ends. Current trials often include periodic review of data to search for early benefit or early harm, but changes are usually only triggered when an overwhelming effect is seen.

Adaptive clinical trials can more seamlessly make use of accumulating information using Bayesian statistics, which allow data analysts to predict trial success based on early patient responses and other accumulating information.

"Adaptive design essentially allows the statisticians to continuously reanalyze the data over the entire study, and we can end up changing how patients are assigned within the study if it really looks like it's working," says Barsan, who is also principal investigator of the clinical trials coordinating center of the Neurological Emergencies Treatment Trials Network. "We believe this is one way to avoid getting false negatives, and it's better protection for patients, which is really important."

The three-year project, "Accelerating Drug and Device Evaluation Through Innovative Clinical Trial Design," is one of four recipients of a $9.4 million award by the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) Joint Leadership Council to spearhead collaborative activities to stimulate a new research in regulatory science.

The project is led by Barsan; Donald A. Berry, Ph.D., senior statistical scientist and founder of Berry Consultants; and Dr. Roger J. Lewis, co-chair of the Regulatory and Ethics Knowledge and Research Program and professor of emergency medicine at the University of California, Los Angeles.

The objective of the grant is to "optimize the design of four large, neurological emergency trials at various stages of development," Barsan says. "We'll use modeling and mathematical simulation to really kick the tires on a number of potential adaptive designs with the hope of gaining efficiency in the ultimate trial design. Hopefully it will lead to considerable savings in the research process and allow us to more accurately and rapidly identify treatments which improve patient outcomes."

For information about clinical and health research volunteer opportunities at the University of Michigan, visit UMClinicalStudies.org.

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University of Michigan Health System

The University of Michigan Health System is an award-winning health care system and premier academic medical center made up of hospitals, health centers, and clinics throughout southeast Michigan; University of Michigan Medical School and its Faculty Group Practice; clinical activities of the University of Michigan School of Nursing; and Michigan Health Corp., the legal entity that allows the Health System to enter into partnerships, affiliations, joint ventures, and other business activities. Excellence in medical education, patient care and research: That’s what defines the University of Michigan Health System.