Factors affecting recruitment to breast cancer clinical trials : an examination of the British Association of Surgical Oncology II trial and the International Breast Cancer Intervention Study
Breast cancer is the most common form of cancer among women in the United Kingdom, and there is considerable investment in research to identify the causes of breast cancer and the best means of diagnosis and treatments. The randomised controlled trial is the principal method used for evaluating diagnostic and treatment options. Trial organisers depend on recruitment of sufficient numbers of patients in order that the results are statistically significant and generalisable, but accrual to cancer clinical trials is poor. This research analyses factors affecting the accrual of women to two breast cancer trials, the British Association of Surgical Oncology (BASO) II trial (a treatment trial) and the International Breast cancer Intervention Study (IBIS) (a prevention trial). The aims were to identify the factors affecting the recruitment of women to breast cancer clinical trials from the surgeons' and multi-disciplinary teams' perspectives and, importantly, from the perspectives of women approached to participate in clinical trials, and their reasons for participation, or non-participation in the trials. There were three phases to the study using multiple methods. In the first phase quantitative methods were used in the form of a questionnaire, sent to consultant surgeons responsible for collecting audit data regarding breast cancer in the United Kingdom. The second and third phase incorporated qualitative methods of data collection; the second phase included in-depth interviews with multi-disciplinary teams; and the third phase involved focus group and individual interviews with women approached to join a breast cancer clinical trial. These three phases were carried out in both the trials examined. The findings contribute to the debate and knowledge of the recruitment of women to breast cancer clinical trials in a number of ways. Firstly, by including the views of all the key stakeholders concerned with breast cancer clinical trials. Secondly, by highlighting the factors affecting recruitment to these two breast cancer clinical trials. Thirdly, by making recommendations on methods to enhance recruitment.