Making randomised trials larger: a simple solution?

Abstract

However, to fully mobilize this workforce, it has to be perceived that the women or consumers themselves have a stake in the clinical trial and that the questions we address and the method of addressing these questions has been scrutinized and perhaps modified by these special interest groups. As an experiment in this direction, I have just established a consumers' advisory group chaired by Mrs Hazel Thornton, a well-known and outspoken advocate of the patients' needs in clinical trials. 8 This new group has been given the task of advising on the design and conduct of a trial of hormone replacement therapy for women with acute or chronic menopausal problems who have been treated for breast cancer in the past. The need for such a trial has been well documented already and yet the ethical dilemma of conducting such a trial is enormous. 9 What better way for such a committee to cut its teeth and to set an agenda for the future. In my opinion, the only way of resolving these dilemmas are for the clinical trial organizations to be perceived as providers and the women themselves as the purchasers. We have the expertise and the scientific methodology to help those women who want to see advances in the prevention and cure of breast cancer. Only by this kind of partnership can we reverse the trend to 'rightism' and protect ourselves from the ill-informed attacks from the self-appointed arm-. chair ethicists.