Box 22 Example of controversial trial results reported by the press in advance of scientific publication

Results of a trial of complementary treatment offered to women with breast cancer who attended the Bristol Cancer Help Centre [38] published in 1990 were reported in the press three days before the Lancet publication date. The women involved in the trial, who still believed it to be ongoing (they had completed only four of the planned five annual questionnaires that they had been asked to complete), first learned the results from the television news. The news report stated that those of them who had been to the Centre were twice as likely to die and three times as likely to relapse as women who had not been to the centre. This was certainly not the most sensitive way of breaking such news. In fact it later emerged that the study was fundamentally flawed in that those who had chosen to pay to attend the centre in addition to NHS treatments were as a group more ill than the controls. The women involved in the trial challenged the results and complained to the Charities Commission about the conduct of two charities, which had funded the research. Their complaint was upheld.

in early discussions of results, this approach has the benefit of preparing doctors for ensuing discussions with their patients. It seems worth exploring whether this approach could be extended to include lay representatives or advocates. They would be bound by the same confidentiality agreements, could actively participate in discussions, could help in the preparation of lay summaries and where appropriate could prepare their groups for counselling patients. Indeed this type of approach has been very successful with HIV trials [39] where there is an established history of advocate groups being actively involved in disseminating trial results to their membership. A similar approach could be successful in cancer.

Researchers have a responsibility to trial participants that extends beyond their enrolment and treatment in a trial. In the UK, the Royal College of Physicians recommends that patients should receive written thanks for co-operating in a study [40]. However, deciding on the best way to inform patients of the outcome needs to be thought through early in the design stages of a trial. Ideally a policy statement on dissemination of results should be part of the protocol, and perhaps also included in patient information sheets. Further research is needed, to investigate the most appropriate methods of implementing such a policy, and to evaluate its effectiveness, with due consideration of the special difficulties that cancer trials may raise.

Was this article helpful?

0 0
10 Ways To Fight Off Cancer

10 Ways To Fight Off Cancer

Learning About 10 Ways Fight Off Cancer Can Have Amazing Benefits For Your Life The Best Tips On How To Keep This Killer At Bay Discovering that you or a loved one has cancer can be utterly terrifying. All the same, once you comprehend the causes of cancer and learn how to reverse those causes, you or your loved one may have more than a fighting chance of beating out cancer.

Get My Free Ebook

Post a comment