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Based on the number of prescriptions, generics represent the top drugs. Almost 60 billion U.S. dollars are spent annually on pharmaceutical R&D purposes in the United States. Interestingly, among the top pharma companies by revenue alone within the U.S. , there are several non-U.S. based companies, for example, British-Swedish AstraZeneca and Swiss Novartis.
Many of the global top companies are from the United States. Together with Canada and Mexico, it represents the largest continental pharma market worldwide. 6. Eapen ZJ, Lauer MS, Temple RJ. The imperative of overcoming barriers to the conduct of large, simple trials.
3. Getz K. Improving protocol design feasibility to drive drug development economics and performance. Further evidence of increasing complexity is apparent in a comparison of the above-described alendronate trials with a recently completed outcomes trial of odanacatib, a new agent that was being evaluated for osteoporosis therapy. The figure depicts the expansion in geographic sites (e.g., in Asia and Africa) for phase 3 fracture trials of odanacatib in 2015 as compared with alendronate in the 1990s.
Yet the opposite is true, and increasing complexity is a key reason ( Table 1 ). 2,3,25,26 Some ongoing outcomes trials will cost a staggering $500 million to $1 billion (an investment made without certainty regarding the result). The examples also illustrate subsequent challenges, such as translating trial findings into clinical practice. If we are to tackle these long-term issues, we need to rethink how we develop such drugs.
In addition to the practicalities of recruiting and retaining patients over so long a period, the drug patent would expire before regulatory approval could be achieved. A trial involving patients at a very early stage of disease could take 10 to 15 years to show efficacy. Therefore, the correct human dose was not revealed in the initial phase 2 trials but was confirmed only in the longer phase 3 trials.
23 These and other trials provided evidence that led to approval of alendronate in many countries for the prevention and treatment of postmenopausal osteoporosis. A second phase 3 trial, the Fracture Intervention Trial (FIT), was in progress at the time of the initial FDA approval of alendronate for the treatment of osteoporosis and was conducted in two parts.
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