... and even more pharma trend predictions for 2010.
Tracy Staton reports in What's the outsourcing outlook for 2010?, what we can expect in 2010 from an outsourcing perspective.
In summmary, expect:
If you're looking to conduct clinical studies outside the U.S., you might do well to read this superb article from Bruce Mackler on GEN, "Spotlight on the FDA Outsourcing Clinicals; Medical Journal Articles; and Contract Manufacturing Liability Issues. Mackler says, "In today’s financing environment, the absence of early clinical data presents a high barrier to obtaining funding. Investors often say “show me the clinical data that show that the drug is safe and works and I will show you my money.” As a result, biopharma companies have moved into early non-U.S. clinical trials that have lower safety data burdens. These studies are being conducted in less wealthy (a.k.a., developing) countries, where Phase I trials can be more rapid and less costly. This strategy has been promoted by CROs established in these countries." The article provides some great tips, not to be overlooked.
Global outsourcing continues, and fuels some interesting debate, as evidenced by this recent New England Journal of Medicine (NEJM) article, "Ethical and Scientific Implications of the Globalization of Clinical Research." Of current interest, one of the author's name, Robert Califf, comes up as a candidate to lead the FDA. In CenterWatch's Clinicial Trials Today post, "Duke, NEJM Study Renews Debate on Global Outsourcing, they say "the NEJM study findings support common criticisms that trial participants in developing countries are often less informed and unduly influenced by the promise of money or medical care in return for participating in a study. While critics of clinical research in emerging areas (comprising 16% of total global clinical trials) can deride the informed consent process there, the West is no stranger to these problems."
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