Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study

Emmy Racine,Patricia Kearney,Caroline Hurley,Joseph Eustace,Carol Sinnott,Mike Clarke,Frances Shiely

doi:10.1186/s13063-017-2148-4

Abstract

BackgroundIn November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a ‘gold standard’, validated approach to RBM does not exist and it is unclear how sponsors will introduce RBM into their organisations. A first step needed to inform the implementation of RBM is to explore academic trialists’ readiness and ability to perform RBM. The aim of this paper is to identify the attitudes and perceived barriers and facilitators to the implementation of RBM in academic-led clinical trials in Ireland.MethodsThis is a mixed-methods, explanatory sequential design, with quantitative survey followed by semistructured interviews. Academic clinical researchers (N = 132) working in Ireland were surveyed to examine their use and perceptions of RBM. A purposive sample of survey participants (n = 22) were then interviewed to gain greater insight into the quantitative findings. The survey and interview data were merged to generate a list of perceived barriers and facilitators to RBM implementation, with suggestions for, and solutions to, these issues.ResultsSurvey response rate was 49% (132/273). Thirteen percent (n = 18) of responders were not familiar with the term risk-based monitoring and less than a quarter of respondents (21%, n = 28) had performed RBM in a clinical trial. Barriers to RBM implementation included lack of RBM knowledge/training, increased costs caused by greater IT demands, increased workload for trial staff and lack of evidence to support RBM as an effective monitoring approach. Facilitators included participants’ legal obligation to perform RBM under the new ICH-GCP guidelines, availability of RBM guidance and perception of cost savings by performing RBM in future trials.ConclusionThe results of this study demonstrate a need for training and regulatory-endorsed guidelines to support the implementation of RBM in academic-led clinical trials. The study provides valuable insights to inform interventions and strategies by policy-makers and clinical trial regulators to improve RBM uptake.

Highlights

In November 2016, the International Conference on Harmonisation (ICH) published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials
Risks associated with the Investigational Medicinal Product (IMP), the vulnerability of the study population and the robustness of the study design are not considered when developing a traditional trial monitoring plan [2, 3]
Regardless of prior risk-based monitoring (RBM) experience, all survey participants said that the Investigational Medicinal Product (IMP)

Summary

Introduction

In November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). The aim of this paper is to identify the attitudes and perceived barriers and facilitators to the implementation of RBM in academic-led clinical trials in Ireland. Monitoring aims to protect the rights and wellbeing of trial participants, support accurate data collection and ensure compliance with regulatory requirements [1]. Trials were monitored through intensive on-site monitoring visits with 100% source data verification (SDV) [2]. Risks associated with the Investigational Medicinal Product (IMP), the vulnerability of the study population and the robustness of the study design are not considered when developing a traditional trial monitoring plan [2, 3]

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