Roche Diagnostics recently conducted a clinical study of "biomarkers" that indicate insulin resistance, involving 62 Type 2 diabetes patients. The thing was, none of the patients were real.
A fascinating Bio-IT World article published today, called "I, Virtual Patient", explains how Roche worked with Entelos, one of the leading software companies offering programs that allow pharmaceutical companies to simulate clinical trials using computers. No human patients required... Geez!
The idea was that using this new "“silico biosimulation" technology”, Roche and Entelos could simulate three different "dietary states" in patients, which might be impractical or nearly impossible with real human volunteers -- who just "might not comply with detailed instructions about exactly what to eat and precisely when to draw their own blood." (Ya think?)
Success! It took the two companies just three months to identify a new biomarker, which could theoretically reduce insulin sensitivity detection to a simple blood test. That's what I call a significant result, without any of the expense or inconvenience of screening and tracking real patients.
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There are, of course, still some questions about whether virtual patients on the whole react to treatment the same way real ones do. In this case, Roche claims that "behaviors were comparable to ... what is observed in diabetic patients in the clinic." Hmm.
Another recent Bio-IT World article states that computer simulation "could revolutionize clinical trials that are often designed and executed haphazardly" -- but also notes that many pharmaceutical companies "remain cautious about simulating clinical trials" for fear of backlash.
The FDA is apparently supportive of the software, encouraging "more modeling, less waste."
To my mind, Entelos CEO James Karis sums it up best:
"... the real power of the software is in exploring 20 or 30 extra hypotheses that no drug company could afford—or that no real trial will ever be able to address. We can make 'knockout' humans—knock out a pathway and say, what happens? We do double, triple doses. Things you could never do in a clinical trial ethically. Simulation becomes a whole investigative research capability. It's not just to replicate what could happen in a clinical trial. We take it way beyond that."