The development of drugs to treat acute stroke or aid in stroke recovery is a multibillion-dollar endeavor that only rarely pays off in the form of government-approved pharmaceuticals. Drug companies spend years testing safety and dosage in the clinic, only to find in Phase III clinical efficacy trials that target compounds have little to no benefit. The lengthy process is inefficient, costly, and discouraging, says Hermano Igo Krebs, a principal research scientist in MIT's Department of Mechanical Engineering.
"Most drug studies failed and some companies are getting discouraged," Krebs says. "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."
Now a robot developed by Krebs and his colleagues may help speed up drug development, letting pharmaceutical companies know much earlier in the process whether a drug will ultimately work in stroke patients.
To receive approval from the Food and Drug Administration, a company typically has to enroll 800 patients to demonstrate that a drug is effective during a Phase III clinical trial; this sample size is determined, in part, by the accuracy of standard outcome measurements, which quantify a patient's ability over time to, say, lift her arm past a certain point. A clinical trial can take several years to enroll appropriate patients, run tests, and perform analyses.
The study's authors found that by using a robot's measurements to gauge patient performance, companies might only have to test 240 patients to determine whether a drug works a reduction of 70 percent that Krebs says would translate to a similar reduction in time and cost.
While pharmaceutical companies would still have to adhere to the FDA's established guidelines and outcome measurements to receive final drug approval, Krebs says they could use the robot measurements to guide early decisions on whether to
|Contact: Abby Abazorius|
Massachusetts Institute of Technology