Bailey A, Crook A, Machin D
Medical Research Council Cancer Trials Office, Cambridge, UK.
Blood Rev. 1994 Jun;8(2):105-12. doi: 10.1016/s0268-960x(05)80015-3.
The object of this paper is to describe the essential features for the design and conduct of clinical trials. We include aspects of patient eligibility, random allocation to treatment including the principle of uncertainty, assessment of endpoints including those observed at different time points for each patient and trial size. Indications of appropriate methods of analysis are given, and the intention to treat principle is discussed. Some pointers to difficulties associated with data collection and management are included.
