Clinical Trials by Stuart J. Pocock(auth.)

By Stuart J. Pocock(auth.)

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They indicate that hospital coronary care units appear not to be of value for a substantial proportion of patients unless one can improve the speed and quality of the patient's initial care, perhaps by the provision of mobile coronary care units. g. length of bed-rest or length of hospital stay after a heart attack) are very difficult to organize. However, as pointed out by Cochrane (1972), it is only by such objective evidence that one can hope to clarify what is the best course of action. Otherwise, one is left in a vacuum of 26 uncertainty where the most enthusiastically supported policies, which may nevertheless be misguided, are likely to be adopted.

It will often require several redrafts of the study protocol until a final more extensive protocol is produced which contains full details of the trial's objectives and organization. Thus, the evolution of a study protocol from its primitive 28 29 beginnings through to the final comprehensive document forms a systematic approach to the development of a clinical trial which is acceptable on scientific, organizational and ethical grounds. The final version of a study protocol needs to serve two main functions.

In general, one should specify which non-protocol drugs (if any) are permissible and under what circumstances. Such ancillary treatment and patient care should be made as consistent as possible: one particularly wants to avoid any disparity of ancillary care between treatment groups and this is one reason for making the trial double-blind (see chapter 6). On an organizational note , the packaging and distribution of drugs require efficient handling. This needs especially careful arrangements if the trial is multicentre or double-blind.

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