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