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This study was designed to evaluate the comparative clinical efficacy and cost-effectiveness of one-stage vs two-stage BVT.
Although differing in design, objectives, and follow-up time, these trials offer some insight into the comparative clinical efficacy of these two nonsteroidal AIs.
Requirements for comparative clinical efficacy studies vary across the guidelines from different countries, with a general trend toward no specific requirement for demonstration of efficacy per se (Table 3) and rather greater focus on safety assessment.
Of the 249 problems identified in their analysis, 154 (62%) related to uncertainty in the estimates of comparative clinical efficacy and 71 (28.5%) related to modelling issues, which included clinical assumptions or cost estimates, used in the construction of the economic models.
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1, 74 Furthermore, in one comparative clinical trial, clinical efficacy and mycological cure rates were lower for flucytosine when compared to fluconazole.
In a phase II, multicenter, randomized, double-blind, parallel, comparative clinical trial, the efficacy and safety of palonosetron (0.25 mg) was compared with granisetron (3 mg) in Chinese cancer patients receiving HEC.
In most Western countries, a comparative analysis of clinical efficacy and/or effectiveness is performed to support national decisions regarding reimbursement or pricing of a pharmaceutical drug or other health care technology.
The clinical efficacy in comparative randomized trials is summarized in Table 3.
14 Comparative clinical trials regarding overall safety, efficacy, and recurrence data are not easily interpretable in the various treatment options as studies looking at each of these points are not uniform in reporting.
While there are few published reports of direct comparative studies, 6 it is generally presumed that such products do not have clinical efficacy comparable with that of prescription topical therapies such as tretinoin.
Fundamental to the successful implementation of antifungal compounds in neutropenic patients is the appropriate design of comparative clinical trials investigating their safety and efficacy.
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