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Official Causes for Attrition

Lack of efficacy is not as solid a reason as might be surmised. If physicians conducting a trial test the drug in mild cases—that is, in patients who would recover on their own—how can the drug be shown to be better than the placebo The drug will fail on lack of efficacy. If the dose given is too low, the drug will also fail on lack of efficacy. Unfortunately, the [Pg.57]

Chapter 6 / About the Economics of 5Eiget and Clinical Candidate Selection [Pg.58]

Testing in mild rather than severe cases presents a difficult dilemma for some conditions. Mild stroke may seem like an oxymoron, but in many cases people do recover with almost no detectable residual deficit or disability. Another is the bacterial infection sepsis, commonly known as blood poisoning, which in its severest form still causes many deaths, but in its mild form may not be especially dangerous in otherwise healthy patients. The alternative to testing in mild cases is to test in severe cases. Unfortunately, in these two examples, any trial restricted to severe cases will be measured against mortality, and no matter how carefully one writes the report, it is not a good outcome if your drug is used on people who eventually die, even if the number of fatalities has decreased. [Pg.58]

Team CNS might now need Tfeam CVD s antihypertensive for self-medication. [Pg.58]


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