A qualitative study to understand the challenges of conducting randomised controlled trials of complex interventions in metastatic colorectal cancer.

Abstract

Background: The use of interventions such as major liver and lung resection, radiofrequency ablation and transarterial chemoembolization in the management of metastatic colorectal cancer (mCRC) is now relatively commonplace in clinical practice. However, the evidence base regarding these treatments is limited with a lack of high-quality data from randomised controlled trials (RCTs). The aim of this study was to understand the challenges associated with conducting RCTs in advanced mCRC and to identify potential strategies to overcome them, with a view to improving trial design and delivery in this setting.

Methods: A qualitative study was undertaken with professionals involved in mCRC trials. Participants were identified using trial registries to identify relevant trials. Individual semi-structured, in-depth qualitative interviews were undertaken online using a topic guide. The principles of thematic content analysis were used for data analysis.

Results: Twelve participants were recruited to the study from six trials; three of the trials had completed, two were either terminated or no longer recruiting and one was open to recruitment. Four major themes were identified, and themes were further subdivided to identify specific challenges and solutions to overcome them. The four themes identified were as follows: trial-related processes, organisational/structural challenges, trial design considerations, and stage IV (metastatic) colorectal cancer-specific factors. Significant challenges were described in relation to funding, ethical approval processes, equipoise, patient preferences, logistical issues in trial delivery, and the advanced nature of mCRC including disease progression and palliative care.

Conclusions: There are a range of strategies which could be implemented to improve the delivery of future trials in this complex setting, from the initial development of a trial through to trial setup, recruitment and follow-up.