Factors that influence the recruitment of patients to Phase III studies in oncology: the perspective of the clinical research associate.

摘要: BACKGROUND The multiple determinants of a patient's decision to enter into clinical trial have been explored largely from the perspectives patients and their physicians. Little research has involved associates (CRAs) formally, despite central role in process recruitment. The current study was initiated explore factors that influence with cancer regarding entry, specifically perspective CRA. METHODS Two focus groups CRAs Hamilton Regional Cancer Center were organized. A skilled facilitator guided both through exploratory subsequent confirmatory phases discussions, which audiotaped for review coding using consensus employing intercoder triangulation. RESULTS The two identified number they believed influenced recruitment process. Numerous physician patient reaffirmed, such as impression scientific merit or sense personal benefit, respectively. More uniquely, information transfer within informed consent major aspect specialized role. It full disclosure information, terms content techniques styles delivery, an important predictor success. quickly reached on most overall respect influencing recruitment. CONCLUSIONS CRAs appear unique recruiting active trials. They believe Further validate this is required, because, ultimately, greater understanding relative roles and, potentially, CRA will be development ethical supportive strategies optimize randomized 2002;95:1584–91. © 2002 American Society. DOI 10.1002/cncr.10864