Pfizer's Trial in a Box: Have you heard about that? I asked Craig Lipset from Pfizer

There has been a lot of recent attention being paid to Pfizer's "Trial in a Box".

I had the opportunity to ask Craig Lipset a few questions about the trial, where patients record data at home vs. in a clinical research setting.

The drug being trialed is already approved for OAB (Over Active Bladder).



My questions: (via Twitter)

1. so the trial is based on what phase of the trial?

Craig Lipset:

"This pilot is technically ph 4. But we are reproducing earlier phase studies to prove the methodology. It's really a method study."

2. how are the patients monitored 24/7? what technology?

Craig Lipset:

"We are actively monitoring safety in a continuous, real-time manner. Pts are connected to us 24/7."


3. What about a medical emergency, would that be anticipated? what would protocol be?

Craig Lipset:

"We would want ANY clinical trial participant going to the ER to notify their investigator site & bring study contact info."


4. curious what the ER staff would need to know abt the possible drug interaction? bring info with?

Craig Lipset:

"Perhaps less surprises on AEs with an approved drug. We are collected AEs diff from most studies (ongoing, continuous, real-time)."


More from Lipset


"We are looking for around 600 women to enter the screening phase of the study (for a 200-300 to randomize)."


"Pts are connected to us 24x7. Round the clock access to the central investigators online and by phone."


"I'm particularly excited about our sharing data and results with patients (incl sending their clinical trial data back via PHR)."


"In many ways this exceeds the cyclical visit-based monitoring in conventional studies."

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Craig Lipset "At Pfizer I am responsible for initiatives in Molecular Medicine to advance personalized therapies, as well as in eHealth leveraging technologies to improve patient engagement in clinical research."


Thanks to Craig Lipset for answering my questions.