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Additional info for Clinical Trials in Cancer: Principles and Practice (Oxford Medical Publications)
Sample text
This type of representation is typical of UK cancer trials, conducted during the 1980s and 1990s. Individual consumer representatives or groups were usually involved in the development of individual protocols, or as members of advisory committees [45]. Although valuable, with this approach there is the risk that lay representatives become isolated or intimidated, perhaps because they do not have adequate training to allow them to participate fully in technical discussions. Providing specialized training is an area where researchers and advocate/support groups can work together towards enabling informed consumer input to clinical research.
Likewise, a study, using in-depth semi-structured interviews, of men participating in a randomized trial (CLasP) evaluating the effectiveness and cost-effectiveness of three different types of intervention for the management of urinary symptoms related to benign prostatic disease, found that almost all participants were aware of some aspects of randomization. Most acknowledged the involvement of chance in their treatment, often transformed to lay terms such as a lucky dip or lottery [26]. However, a revealing study that involved interviewing parents who had consented for their critcally ill infants to enter a randomized trial, found that although superficially many appeared to know that the trial was randomized, when questioned further it became clear that few understood either the design of the trial or how or why randomization was done [27].
A joint statement was then released by the NCI and the American Cancer Society stating that ‘mammography screening of women in their 40s is beneficial and supportable by the current scientific evidence’ thereby completely at odds with the original panel recommendation. Statements of approval by many politicians including the President followed quickly. 19 20 CLINICAL TRIALS IN CANCER Of course clinical research cannot operate in a vacuum and everyone (even politicians) is entitled to their opinion and input.