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As we have indicated, an important consideration at the design stage of a trial is to consider whether, if the new treatment proves effective, the trial will be reliable enough in itself to convince clinical teams not associated with the trial of the findings. Importantly, if a benefit is established will this be quickly adopted into national clinical practice? Experience has suggested that all too frequently trials have less impact than they deserve although it is recognised that results that are adopted in practice are likely to be from trials of an appropriate size, conducted by a respected group and have multicentre involvement. Thus, there are considerations, in some sense outside the strict confines of the design, which investigators should heed if their findings are to have the desired impact.

Some basic or administrative things can help reassure the eventual readers of the reliability of the trial results. These include, although some of these may be mandatory, registering the trial itself, involving and informing other clinical colleagues outside the trial team of progress, careful documentation of any serious adverse events, ensuring the trial documentation is complete, establishing procedures for responding to external queries, clarity of the final reporting document in the research literature and seeking avenues for wider dissemination of the trial results.