Drug Effectiveness Review Project
I again refer you to this important review of the DERP in this special online issue of Health Affairs. The articles highlight many of the important issues involved in evaluating drug effectiveness. One issue, highlighted in the Pfizer editorial by Newell et al., is the issue of extrapolating population-based evidence to individual patient care. This has been an interest of mine for the past few years ever since I discovered at a gathering of pharmaceutical industry clinical scientists that a majority of them, even those with many years of experience, believe that the randomized, controlled clinical trial is not only the gold standard for gathering evidence of a drug’s effectiveness in a selected clinical-trial population but is also the best way to determine a priori whether an individual patient will benefit from a therapy. The first time I heard this argument raised (in objection to a comment I made off-handedly to the contrary) I was so surprised that I found myself unwilling to undertake a debate with the gathered group before me; I was literally left speechless. This article reminded me of my shock that day. I can’t do the topic justice in a blog post, so I will add it to my list of topics for a future paper, perhaps one for peer review and publication, perhaps just a white paper. If you’re interested in the topic and would like to debate it in print, let me know. Otherwise, I wanted to let you know that I soon will publish a white paper on the topic of evidence-based, science-driven strategy for the pharmaceutical R&D manager. The paper draft suggests a final work too long for PCE, but I’ll try to condense it down for the June PCE post. I’ll also publish on my company’s website at http://www.pharmagrowth.com/library.html
