Designing clinical trials to impact on clinical practice: is big better?
Janet Dunn*, Richard Gray, Linda Ward and David J Kerr CRC Trials Unit, Cancer Research Campaign Institute for Cancer Studies, Birmingham, United Kingdom There has been a trend in phase III cancer clinical trials to move away from small (less than 250 patients), detailed, data-intensive studies to large (over 1000 patients), simple, pragmatic designs. Our experience in setting up, conducting, resourcing and completing these studies has shown that involving a dedicated steering committee and maintaining continued commitment for recruitment drives are needed to ensure the success of the trial. In the design stage, the involvement of several clinicians may lead to more pragmatic designs. Clinicians sometimes argue that the detailed documentation they would like to see before they can truly be persuaded to alter clinical practice in favour of a new treatment may be compromised by the simple design of these large studies. For example, if a trial of two chemotherapy regimens indicates that o
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