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The contents of this section will depend to a large extent on the size and complexity of the design of the trial. For example, protocol SQCP01 (2000) involves only two clinical centres but different countries with very different first languages, and which are geographically quite distant. Because this trial is organisationally complex, and involves many clinical disciplines, including specialists in surgery, orthodontics, and speech therapy each with roles to enact over a very long period of 17 or more years, keeping track of the individuals concerned is a major challenge. However, each centre has long experience of dealing with such complex issues so the protocol runs with four named craniofacial/plastic surgeons, four orthodontic coordinators, three speech therapy coordinators and two research coordinators. At the statistical centre a medical statistician and clinical project coordinator are designated to the trial. The protocol contains full names, addresses, telephone, fax and email addresses of these individuals. As may imagined, the actual individuals concerned will no doubt change as the trial progresses forward in time.

In contrast, the SQNP01 (1997) was conducted within a single centre and three clinical coordinators were identified, one representing radiation oncology, the other two medical oncology. The conduct of this trial reflected the day‐to‐day management practices of the centre concerned. At the statistical centre, a medical statistician was designated and a nurse coordinator had shared responsibilities for the trial within both the statistical centre and the clinic from where the patients were recruited. The protocol contains full names, addresses, telephone, fax and email addresses of these individuals.

In situations where the demands of a trial are somewhere between these two extremes, the protocol development team must ensure that the necessary organisational structure is in place and each component thereof knows of their individual responsibilities. One important role of the trial office is to help maintain this functionality throughout the life of the trial.

If at all possible, the protocol should fit as closely as possible within the confines of current practice in the centres concerned, with the proviso that the aims of the trial are not compromised by so doing. This facilitates acceptance of what is new in the protocol from the local team and thereby should help with the smooth running of the trial and hopefully maximise recruitment rates.