Clinical Trial Design
Sue Fitzpatrick. Edited by Nina Downes, Diamond Clinical Ltd.
“Inappropriate or bad trial design may have consequences that are more far-reaching than the failure of one trial alone.”
Clinical trials should be designed, conducted and analysed according to sound scientific principles to achieve their objectives and should be reported appropriately. The essence of rational drug development is to ask important research questions and answer them with appropriate studies.
This monograph goes through the steps of choosing the right type of design for the right type of study. It describes what kinds of studies there are, how to take into consideration the patient population, cover the areas of bias, randomisation and blinding as well as discussing the needs of multicentre trials. It ends with a consideration for evidence- based medicine together with the current climate of transparency of clinical trial data in databases and published articles.
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