Almost exactly four years after Pfizer ($PFE) wowed the clinical trial sector with its plans for a virtual, fully-remote study, one of the people behind the project has outlined how the industry is continuing to move the methods it pioneered toward the mainstream.
MobiHealthNews heard from Craig Lipset, head of clinical innovation at Pfizer, at BIO, where he said the tools tested in the 2011 virtual trial are still being incorporated gradually into more traditional bricks-and-mortar studies. And Pfizer is no longer alone in the virtual trial sphere. Sanofi ($SNY) is working on a virtual trial in Europe and Lipset has spotted others that are pushing similar programs. Such an expansion of the concept was part of what the virtual trial team hoped to achieve when it decided to publish and share details of the initiative.
"We shared it not just out of altruism, we shared it because, if it's just a Pfizer thing, we're not going to have support from regulators and other providers. We needed it to be more widely adopted. And I've been encouraged that there now have been at least three other pharma companies that have picked up where we left the ball on the field and have taken that farther down," Lipset said. Through such openness Lipset thinks approaches pioneered in the virtual trial can advance beyond "clever little pilots" and become part of the toolkit for mainstream clinical development programs.
The needs of such composition of drug development pipelines--and by extension the requirements of clinical trials--have evolved since Pfizer began planning the virtual study in the final days of the blockbuster era, notably because of the move toward more targeted therapies. Yet Lipset thinks the design of trials has failed to keep up with pipeline evolution. "We have models of clinical development that were built for a blockbuster era," he said. Lipset sees the methods pioneered by the virtual trial playing a role in bringing studies in line with today's pipelines.
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