There have been several articles from 2007 through 2011 discussing the validity of computer modeling/simulations in clinical drug development and in particular clinical cancer research. An article that is of interest to me was published in the Journal of Clinical Oncology, authored by Rebecca A. Miksad, MA,MPH http://tinyurl.com/k4ebnf9 The article focuses on informed decision-making that can occur when you bridge the gap of information with computer modeling.
In reviewing the literature I found only a couple of articles on Computer Simulation in Clinical trials. Because of the current focus on the high cost of drug development and of course, the uncertainty with regard to success/FDA approval, I imagine that we would be inundated with new products dedicated to simulation of clinical trials. Why don’t we have more commercial software products dedicated to simulation of clinical trials? The FDA has accepted simulation results; are their regulatory hurdles that make this technology challenging and thus, obtaining approval for new medications an uphill battle?
In my opinion, to use this technology to help evaluate first in man data and to help in designing clinical protocols, would reduce costs, reduce the risk of failure and help with the important Go/No decisions many Biotech/Pharma are faced with.
We constantly hear about the high cost of drug development and the length of time from early development to FDA approval. That being the case, it seems that we should embrace computer simulation because of the critical role it can play in clinical study (trial) development. Why not start a Computer Simulation project. What do you think?
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My Perspective - Kathryn Davis 