FACTORS AFFECTING RECRUITMENT TO SURGICAL ONCOLOGY CLINICAL TRIALS AND OPPORTUNITIES TO IMPROVE ACCRUAL

Abstract

Surgical trials involve patients undergoing a surgical intervention. Poor recruitment is the most important issue that can lead to study failure. Chapter 1 provides the conceptual framework of recruitment issues that can arise when conducting a surgical trial. Different methodological challenges that lead to poor recruitment are discussed based on the different steps of a trial. It provides a rationale for conducting the included studies. Chapter 2 describes a double blind, placebo controlled randomized clinical trial; a pilot feasibility trial evaluating the use of perioperative nutritional supplements versus placebo for patients undergoing gastrointestinal cancer surgery. This chapter expands on issues related to recruitment to surgical trials in this setting (i.e., surgical trials that compare a medical intervention or drug among patients undergoing surgery) and explores potential opportunities to improve accrual. Chapter 3 presents a single arm, multi-institutional, pilot trial, evaluating the feasibility of enrolling patients to a trial involving an innovative surgical intervention. This chapter evaluates recruitment issues to surgical trials that investigate surgical interventions and explores potential solutions to these challenges. Chapter 4 reports on a prospective study that was performed alongside the trial presented in Chapter 3 that evaluated the use of population-based electronic databases as a possible opportunity to improve accrual. Chapter 5 describes a protocol for a randomized controlled trial comparing simultaneous versus staged resection for synchronous colorectal cancer liver metastases. It uses the results gathered from previous trials for its design and proposes the use of population-based databases as a recruitment strategy. Chapter 6 discusses the lessons learned from the two different trials and the one prospective cohort study as a form of conclusion, examining possible opportunities to improve recruitment, based on the challenges described in this PhD thesis. This chapter also discusses limitations as well as future research planned based on this thesis work.