Trial Designed With Crowd Input Gets FDA Signoff

Marc Iskowitz | MM&M | December 28, 2012

What's been called the first clinical study protocol developed using crowdsourcing methods received the FDA's imprimatur earlier this month. The agency approved Transparency Life Sciences' IND for a clinical trial designed to test a generic blood-pressure medication, ACE inhibitor lisinopril, in patients with relapsing remitting multiple sclerosis.

“We believe that we are the first clinical protocol cleared by the FDA that included input from patients as well as physicians and researchers,” Tomasz Sablinski, MD, PhD (pictured below), founder and CEO of Transparency Life Sciences, told MM&M in an e-mail.

Data will be collected directly from subjects in the yearlong, 150-180-patient placebo-controlled study with the help of remote-monitoring technology from another firm, Advanced Monitored Caregiving, making it a so-called virtual trial as well...