Pfizer's virtual trial: Open-source meets old pharma

CHICAGO -- Drug giant Pfizer revealed more details of its all-electronic clinical trial at the DIA's 47th annual show here, going to great lengths to acknowledge its partners in the endeavor and to credit collaboration for the achievements to date.

The news sounds big coming from a big pharma, especially given that the FDA is onboard. Pfizer's head of clinical innovation Craig Lipset took pains to appreciate the regulatory and Institutional Review Board input his project has received. And he acknowledged the contributions of partners Steven Cummings of Mytrus, which provided the front-end tech build-out of the investigator sites; Cameron Robertson, business development manager at Exco intouch, provider of the mobile e-diary equipment; Perceptive Informatics, for its back-end technology work; and the University of California investigational team.

"It's hardly Pfizer's technology," said Lipset, sounding less like a Big Pharma practitioner and more like an open source advocate. "We don't believe Pfizer owns this approach. We want to see greater uptake in the wider community." He said he believes the model can scale internally and perhaps eventually be used as modules in conventional studies in a form of "disruptive new medicine."

His words are strikingly similar to those of Tomasz Sablinski, head of clinical development at private equity concern Celtic Therapeutics, in a FierceBiotech IT interview last February: "If you want to introduce disruptive [technology], you have to go out on your own," he said. "You can't do it from within." Sablinski in his spare time is launching Transparency Life Sciences, an open-source drug development enterprise.

Both Sablinski and Lipset acknowledge the great contribution to be made by telemedicine, with apps that are "growing at the speed of light" yet rarely used in pharma [Sablinski], and an "app store of tools from telemedicine, which can help expand health IT connectivity." [Lipset] sees the use of telemedicine apps in clinical trials as "a repurposing rather than inventing." On the innovation behind his project, Lipset says, "there are two approaches a company like Pfizer can take. One is private, to hide it. We took the more challenging way--with qualification, regulators, the IRB. They're all partners now."

Sablinski for the most part agrees with Lipset. But he has one quibble: "Pfizer concocted the trial in secrecy; the old way." He implies the drug giant worked on the effort for months internally before reaching out to others. To extrapolate what Pfizer did to a truly transparent model, the drugmaker would have spoken up earlier and said to the larger community of stakeholders, "we want to conduct an all-electronic trial. How do we design it?"

But he's not complaining. "For me, [the Pfizer project] is a godsend." If it succeeds, it validates his concept for the fledgling open-source Transparency Life Sciences. - George Miller (email)