MIT Robot Seeks Accelerated Trials for Stroke Medication

Clinical efficacy trials for the development of drugs that treat acute stroke or aid in stroke recovery are often "inefficient, costly, and discouraging," according to Hermano Igo Krebs. Krebs, a principal research scientist in MIT's Department of Mechanical Engineering, might be able to provide a solution with the development of a robot. The MIT-Manus has shown the potential to cut time and cost of Phase III drug trials by 70%.

If this can be a reliable step in the drug development process, the use of the MIT-Manus could potentially revive drug studies; they wouldn't be as lengthy or costly--two big concerns for companies attempting to develop new drugs.

"Most [stroke] drug studies failed and some companies are getting discouraged," said Krebs in this EurekAlert! article. "Many have recently abandoned the neuro area because they have spent so much money on developing drugs that don't work. They end up focusing somewhere else."

MIT-Manus, the robot developed by Krebs and his colleagues, is believed to significantly speed up the Phase III clinical trial. Its goal is to help companies pursue studies that are showing some promise before arriving at the Food and Drug Administration's daunting approval process. Before the FDA authorizes a drug, companies that seek approval must enroll 800 patients to prove a drug's effectiveness. The participant pool is so large because it is the most accurate way to record the standard outcome measurements over time. This could take several years, which is a long time for a drug that may not even be efficacious.

The authors of this study, published in the journal Stroke, sought to reveal that the MIT-Manus might be able to narrow the clinical trial down to 240 patients because of the machine's ability to precisely gauge the measurements of patient performance. A reduction in patient participation would reduce Phase III of the clinical trial by 70%, slashing both time and cost. Although these findings would not change the FDA's policy on drug approval, it would convince companies to further invest money into a drug that is showing extremely promising progress among a small sample size.

There are only a few stroke drugs in the late stages of development, which could help convince more companies to undertake Krebs' strategy in using the MIT-Manus.

To read more about the MIT-Manus and Krebs' study, visit this EurekAlert! article as well as the journal Stroke.