Informing participants about the results of trials

There is widespread agreement that those asked to participate in clinical research should be given adequate information concerning the aims and design of a trial. However, in cancer it is currently the exception rather than the rule that participants are actively informed of a trial's results by its organizers. Yet, studies have shown that patients have a strong desire to receive feedback about the trials in which they have taken part [33-35].

The way that results of trials are communicated to patients and their families needs careful thought, as results can be complicated, alarming and distressing. It has been suggested that this is particularly true of randomized trials [35] where patients who did not receive the favoured treatment may, in retrospect, feel that they have been deprived of the best treatment or placed at risk. Nonetheless, the indication is that those who take part in trials do wish to be informed of the results, even if the information that they receive can be potentially upsetting. For example, a survey of the parents of surviving babies enrolled in the ECMO trial, described previously, found that even though feedback was emotionally exacting (significant differences in mortality were observed), the parents still wanted this information [36]. Parents seemed to find that, although upsetting, the provision of information about the trial results removed uncertainty, provided a clear end to difficult events, promoted further discussion within the family and acknowledged their contribution to answering an important clinical question.

Providing trial participants with feedback about results may well be particularly difficult in cancer, not least because in advanced disease a large proportion of patients will have died before the close of the trial. The situation is likely to vary according to cancer site and from trial to trial. However, at least in cases where long-term survival is anticipated, there is a strong case for providing details about the results of a trial, written in lay terms, for those who have taken part. So far, this approach has not been used widely in cancer, but it is an issue that should be taken into consideration by those designing new trials. It would be a much more reliable way of reporting the results and implications and more reassuring to those involved than for them to obtain this information through the media. There have been calls for patients to be furnished with trial results in advance of scientific publication or presentation [37]. This stems in part from situations where results of high profile studies have been reported by the media at the same time as, or even before, scientific publication. Those who had taken part learned of striking or controversial results from television news or newspapers. This type of situation can clearly be very distressing for those involved (see Box 2.2), and information received in this way maybe a selective or edited version of the results and conclusions of a trial. Although it maybe difficult to inform all participants of the results of trials before publication, with careful planning it should be possible for trialists to link the circulation of lay summaries of the results of trials with the date of publication. It is now fairly common practice for the results of trials to be presented, in confidence, to the clinicians involved prior to publication. As well as the scientific advantages of involving participating clinicians

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