Abstract
ABSTRACT Aim: Recruitment to clinical trials can be challenging and slower than anticipated. We performed a prospective service evaluation to enhance our understanding of pts' views of clinical trials in order to improve trial recruitment. Methods: Pts who had been approached about participation in a clinical trial in the RM Gastrointestinal and Lymphoma Unit were invited to complete an extensive questionnaire, which included questions regarding their opinions on aspects of cancer research, attitudes towards clinical trials and views on the quality of information provided. Information on pt demographics and subsequent enrolment into clinical trials was collected from pt records. Results: From August 2013 – March 2014, 167 pts received 181 clinical trial pt information sheets (PIS) and were asked to complete the questionnaire. 81 PIS were for clinical trials of an investigational medicinal product (CTIMP) and 100 were for non-CTIMPs. 88% of respondents (Res) consented to a trial (81% for CTIMPs, 93% for non-CTIMPs) and 97% of these Res completed the questionnaire. The factors identified as the “most important” influences on participation were that the trial result could benefit others (30% CTIMPs, 66% non-CTIMPs) and that the trial offered the best treatment available (43% CTIMPs). Other factors influencing participation included trust in the treating doctor, a wish to contribute to research and a belief that they would be monitored more closely. 74% of all Res would consider participating in a study which required a research biopsy and 78% of non-CTIMP Res stated they would have been happy to consent to the trial on the day they received the PIS. Recruitment will be completed in July 2014 and data for the 12 month period will be presented. Additional data, including Res' opinions on genetic research, tissue storage, the quality of the written and verbal information provided and any associations between Res' opinions and their demographics (e.g. age, gender, treatment setting) will also be presented. Conclusions: The majority of Res approached consented to clinical trials and completed the questionnaire. Reasons for trial participation varied according to trial type and a high proportion of pts were willing to consider studies involving biopsies. Disclosure: All authors have declared no conflicts of interest.
Published Version
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