Читать книгу Randomised Clinical Trials - David Machin - Страница 90

The alternative interventions or therapeutic options should be carefully described within the protocol, with details of what to do if these require modification or discontinuation for an individual participant. Interventions may be terminated for many reasons ranging from refusal of individuals to remain in the trial, or a clinical team’s concern that the next stage in the intervention is no longer appropriate for the patient in question. Early stopping is of particular concern in trials where the interventions could result in serious untoward consequences. In some situations, such events would not be anticipated whereas in other circumstances they may be expected and are a known consequence of the treatments under test. There will always be occasions when the unanticipated occurs, and patient safety and well‐being should be paramount in clinical trials just as in daily clinical practice.