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Clinical trials common designs

Phase II clinical trials are designed to evaluate the producfs efficacy and side-effect profile. About 100-300 patients are involved. Data obtained are used to characterize the dose-response relationship. The costs involved are about 10-100 million Euro over 1- to 2-year period. The success rate is about 40%. Studies performed may be characterized by a single or multicenter study, single- or double-blinded with a control group and randomization of the patients. Amongst the most common reasons for failure at this phase are poorly designed studies and ineffective or unsafe products. [Pg.1696]

The idea behind the use of concurrent controls is so simple that it would scarcely seem to be worth discussing, yet, despite the essential simplicity of using concurrent controls, analyses of clinical trials commonly encountered in the medical literature betray the fact that tricdists often do not understand the implications of having adopted such a design. [Pg.34]

The most common criticism of our meta-analysis is the claim that the clinical trials we analysed were flawed, and that better results would have been found if the studies had been designed better. The trials were too short to show the real effect of antidepressants, the critics said. The people recruited to participate in them were not depressed enough, or they were too depressed. In any case, they were not representative of the patients who are generally seen in clinical practice. [Pg.62]

A recent European regulatory document (CHMP (2006) Reflection Paper on Methodological Issues in Confirmatory Clinical Trials with Flexible Design and Analysis Plan ) has given more thought to what is acceptable and what is not, in terms of flexible design. Several common themes are seen to run through this paper ... [Pg.225]

Case report forms (CRFs) are used throughout clinical trials to record data collected during a trial. They record all of the information specified in the protocol for each subject (all data recorded on the CRF must be verifiable from original source documentation). While the traditional paper CRF format is still used, electronic data collection is becoming more common. Voorhees and Scheipeter (2005) discussed CRF development in detail, highlighting some of the fundamental aspects of their purpose, design, and nature ... [Pg.73]


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