Planning and Organization of Therapeutic Studies
The plan and the organization are the two most important aspects of any therapeutic study. Without an adequate plan, and sufficient organization to implement it, the results will be of uncertain validity.
The four essentials for an adequate plan are a clear definition of the aims and scope of the trial, a good expectation of a worthwhile practical advance, a random procedure for the allocation of patients to the treatment series, and the subsequent maintenance of similar management and assessment in each treatment series.
There are also four essentials for the organization to serve this plan, namely informed, enthusiastic and dedicated investigators, a sufficiency of administrative arrangements, clear arrangements for recording the observations, and a written reference “protocol”.
If these are achieved, the investigator can be confident that the trial will provide reliable and analysable results. The comparison of the treatments will be unbiased, and as precise and informative as possible.
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