Patients' perceptions of research biopsies in Phase I Oncology Trials

Lemech, C., Dua, D., Newmark, J., Saggese, M., Simmons, E., Spiliopoulou, P. and Arkenau, H.-T. (2015) Patients' perceptions of research biopsies in Phase I Oncology Trials. Oncology, 88(2), pp. 95-102. (doi: 10.1159/000368161) (PMID:25322682)

Abstract

Objective: Research biopsies are increasingly incorporated into phase I oncology trials resulting in ethical and logistical challenges for patients and clinicians. Patients' understanding and willingness to undergo these biopsies are crucial. Methods: Over 12 months, we administered a questionnaire comprising three sections: demographics and previous cancer therapy, understanding of phase I trials and personalized medicine, and understanding of biopsies and associated risks. Results: Out of 56 patients approached, 47 patients completed the questionnaire. Overall, the patients were well informed about the concepts of personalized medicine and 89% (n = 42) were aware that early phase clinical trials aim to define a dose and explore side effects of new drugs. Interestingly, 76% (n = 36) expected early phase trials to improve symptoms, quality of life and survival. Offering hope and feeling in control of their treatment were important components for 80% (n = 38) and 57% (n = 27), respectively. The majority of this highly selective patient cohort understood the concept of research biopsies, with 59% (n = 28) willing to have a fresh research biopsy for trial participation. Although 72% (n = 34) felt that research biopsies should be optional, only 19% (n = 9) would not participate in a clinical trial with mandatory biopsies. Compared to diagnostic biopsies, the patients were less likely to accept associated risks with research biopsies. Conclusion: As research biopsies are crucial to many components of the drug development process, our study provides evidence for patients' overall willingness to undergo research biopsies for trial purposes. A consent process tailored to the biopsy site may help patients weigh up the associated risks versus benefits.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Spiliopoulou, Dr Pavlina
• Authors: Lemech, C., Dua, D., Newmark, J., Saggese, M., Simmons, E., Spiliopoulou, P., and Arkenau, H.-T.
• College/School: College of Medical Veterinary and Life Sciences > School of Cancer Sciences
• Journal Name: Oncology
• Publisher: S. Karger AG
• ISSN: 0030-2414
• ISSN (Online): 1423-0232