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Balanced Portfolio of Clinical Candidates

The list of factors that come into play is indicative of the complexity. For example, the absolute risks of different trials ranges from no improvement while on the drug to actual increased mortality. The length of trials is different antibiotics, 14 days, an Alzheimer drug, at least 24 months, and an osteoporosis drug is 36 to 48 months. The size of trials depends on the improvement one wishes to demonstrate and the natural rate of disease progression. One might only need 30 to 40 patients for a trial on some rare tumor disease, in stroke or sepsis, from 60 to 200 patients, but in cardiovascular medicine or obesity, one needs 2,000 to 10,000 patients to have some idea of efficacy. As a reminder, the key for these clinical trials is Is there a sufficient number of patients who are well characterized and who could enter the trial so that we will have the statistical power to [Pg.189]

129 This is done even at some staggering hundreds of millions of dollars in cost because calculations show that it is worth more to obtain a better or no label. [Pg.189]

To smooth out the bumps, curves, and reversals, each Big Pharma has 30 to 40 clinical trials ongoing all the time. So losing one is sad for the team that worked on it, but they can come back tomorrow to start on a new project. In Biotech the ups and downs are a real drama watched by investors and employees with the same anxiety  [Pg.190]


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Candidates

Candide

Clinic candidate

Clinical candidate

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