Enrolment in clinical trials

Despite recent advances, the five-year survival rates for many cancers remains low, and there is a continued need for research to improve cancer outcomes. Clinical trials represent the gold standard approach to providing evidence for advances in treatment. Clinical trials are research studies designed to improve cancer prevention, diagnosis, treatment and survivorship. This research base necessarily involves enroling cancer patients and others (for example, family members for genetic linkage studies, healthy community volunteers to serve as matched controls) into clinical trials. As with any research enterprise, patients and others voluntarily enrol and maintain their status as participants in these trials. Unfortunately, many medical and surgical oncology trials have insufficient accrual rates, a problem that has plagued the implementation of clinical trials for many years. Low accrual severely hinders progress in cancer treatment and prevention. This chapter outlines issues involved in recruitment to clinical trials, describes the ethical principles underlying informed consent and suggests strategies to aid communication between healthcare providers and patients about clinical trials.