Chip Away At The Stone: REMOTE, Transparency Life Sciences

Lisa Henderson | Applied Clinical Trials | February 1, 2013

(This blog is part 2 of my interview with Tomasz Sablinski, MD, PhD, Founder and CEO of Transparency Life Sciences.

As noted in my first blog, Sablinski’s company announced it was the first company to have an IND cleared using a crowdsourced protocol. As part of the protocol, extensive use of telemonitoring in place of regular site visits is achieved through its partner AMC Health. In this protocol, specifically a Phase II trial to assess lisinopril as an adjunctive therapy for multiple sclerosis (MS), the only patient visits are at day 0, and on the last visit in month 12. And by virtue of these visits, the trial is not wholly virtual--not in the way the Pfizer REMOTE trial was virtual.

I’m not the first one to make the REMOTE-TLS comparison. Both the REMOTE trial and the TLS trial rely on technology for the intertwined goals of reducing clinical trial costs, gaining efficiencies and eliminating waste using technology. In REMOTE’s instance, a whole host of technologies were used--ranging from EDC, to IVRS, to ePRO to online patient recruitment. TLS relies on a transparent web-based Protocol Builder to design better clinical trial protocols and the aforementioned telemonitoring services to reduce clinical trial costs and increase patient convenience.

“The biggest similarity with REMOTE is the desire to change the paradigm,” stated Sablinski of TLS. He is very supportive and appreciative of the efforts of Pfizer for trailblazing the concept, and to Craig Lipset, Head of Clinical Innovation, Development Operations within Worldwide Research & Development at Pfizer, for pushing the innovation forward internally...