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A paper published in Nature by Begley and Ellis, addressed the major issue facing pre-clinical studies and their translatability into clinical trial efficacy. The paper references, Hutchinson & Kirk’s 2011 paper in Nature Reviews Clinical Oncology that found “Only 5% of agents that have anticancer activity in preclinical development are licensed after demonstrating sufficient efficacy in phase III testing”. So with this information, they hypothesized that the ‘landmark’ pre-clinical studies, in which many of the clinical trials are based on, may not be reproducible and that is where the low success rate originates from. With these high drug attrition rates in clinical anticancer drug studies, do you think it’s important to show reproducibility of YOUR studies? Even if they don’t involve drug efficacy or toxicity? Begley and Ellis, go on to confirm that only 11% of those ‘landmark’ preclinical studies had reproducible results. Which is quite shocking given that some of these were used as support for drug testing approval in clinical trials or used as references in such papers. Who should be responsible for ensuring reproducibility? Just the PI? FDA? Sponsors? Another issue all researchers know all too well is that funding has been cut in many areas, making grants more competitive and leaving a lot of research unfunded. So what is the motivation for scientist to reproduce results that have already been performed and published? How will they justify the need on a grant when they are specifically designed to ensure no two studies are repeated? How will these reproducibility studies be funded and supported? Gov’t grant? Pharma? Others? Ultimately, what needs to change in order for more reproducibility studies to be performed and for preclinical trials to translate more effectively into clinical success? Below I’ve copied the links to both papers referenced, check them out for more information. Begley, C. Glenn, and Lee M. Ellis. "Drug Development: Raise Standards for Preclinical Cancer Research." Nature 483.7391 (2012): 531-33. Web http://www.nature.com/nature/journal/v483/n7391/full/483531a.html Hutchinson, Lisa, and Rebecca Kirk. "High Drug Attrition Rates—where Are We Going Wrong?" Nature Reviews Clinical Oncology 8.4 (2011): 189-90. Web. http://www.nature.com/nrclinonc/journal/v8/n4/full/nrclinonc.2011.34.html

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