Abstract
This paper presents the methodological approach and research methods chosen to explore psychosocial aspects of participation in early anti‐cancer drug trials from the perspective of those actually involved. The paper describes how an appropriate methodology, or principles of reasoning behind the choice of research methods, emerged. The choice of methodology was based on three elements: first, an understanding of the competing philosophies about how research can be approached and conducted; second, the author’s view of the subject area; and third, a consideration of previous research approaches which have investigated psychosocial aspects of cancer clinical trials. A qualitative methodology situated within an interpretative paradigm was eventually chosen as the most appropriate means of exploring trial participants’ experiences and the aim and objectives of the research were developed within this methodological framework.