The rights of patients in research

Patients must come first in research

Clinical trials cannot be done without patients, and the whole purpose of conducting trials is to benefit patients. These two indisputable statements should mean that patients should be at the front of researchers' minds when they design, conduct, and report medical research. But they rarely are. Too often patients are forgotten in the complex business of conducting research. We argue that patients should help to decide which research is conducted, help to plan the research and interpret the data, and hear the results before anybody else.

The patients certainly seemed to have been forgotten in the notorious case of the “trial” of the complementary treatment offered to women with breast cancer by the Bristol Cancer Help Centre.1 The women who had willingly participated in the research knew nothing of the results until they heard on the television news on the evening of 5 September 1990 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.

As far as the women were concerned, the study was still in progress and they had received only four of the five annual questionnaires they wereexpecting to be asked to complete as part of the five year study. Nobody had sought their permission to publish interim results, and no one had written to thank them for their cooperation (as recommended by the Royal College of Physicians2) or to communicate even in broad outline the conclusions of the study. Instead, the results were published in the Lancet (dated 8 September) and released prematurely to the media with a fanfare of publicity. (The BMJ contributed by publishing a news story entitled “Death from complementary medicine.”3) The result was desolation for the women …