Generating evidence on a risk-based monitoring approach in the academic setting \u2013 lessons learned

Belinda Von Niederhäusern,Pascal Benkert,Annette Orleth,Christiane Pauli-Magnus,Nawal Rawi,Sabine Schädelin,Claudia Becherer,Matthias Briel,Priya Satalkar,Martin Velkopolszky

doi:10.1186/s12874-017-0308-6

Abstract

BackgroundIn spite of efforts to employ risk-based strategies to increase monitoring efficiency in the academic setting, empirical evidence on their effectiveness remains sparse. This mixed-methods study aimed to evaluate the risk-based on-site monitoring approach currently followed at our academic institution.MethodsWe selected all studies monitored by the Clinical Trial Unit (CTU) according to Risk ADApted MONitoring (ADAMON) at the University Hospital Basel, Switzerland, between 01.01.2012 and 31.12.2014. We extracted study characteristics and monitoring information from the CTU Enterprise Resource Management system and from monitoring reports of all selected studies. We summarized the data descriptively. Additionally, we conducted semi-structured interviews with the three current CTU monitors.ResultsDuring the observation period, a total of 214 monitoring visits were conducted in 43 studies resulting in 2961 documented monitoring findings. Our risk-based approach predominantly identified administrative (46.2%) and patient right findings (49.1%). We identified observational study design, high ADAMON risk category, industry sponsorship, the presence of an electronic database, experienced site staff, and inclusion of vulnerable study population to be factors associated with lower numbers of findings. The monitors understand the positive aspects of a risk-based approach but fear missing systematic errors due to the low frequency of visits.ConclusionsWe show that the factors mostly increasing the risk for on-site monitoring findings are underrepresented in the current risk analysis scheme. Our risk-based on-site approach should further be complemented by centralized data checks, allowing monitors to transform their role towards partners for overall trial quality, and success.

Highlights

In spite of efforts to employ risk-based strategies to increase monitoring efficiency in the academic setting, empirical evidence on their effectiveness remains sparse
Clinical Trial Unit (CTU) monitors are qualified by training and experience and work according to clearly defined standard operating procedures (SOPs) which are reviewed and updated by an autonomous qualityassurance officer on a regular basis
The risk evaluation adopted by the CTU (Table 1) includes a structured trial risk classification by the project manager according to the ADApted MONitoring (ADAMON) project and the Swiss Human Research Act as described by the Swiss Clinical Trial Organization [21]

Summary

Introduction

In spite of efforts to employ risk-based strategies to increase monitoring efficiency in the academic setting, empirical evidence on their effectiveness remains sparse. This mixed-methods study aimed to evaluate the risk-based on-site monitoring approach currently followed at our academic institution. Risk analysis takes into account the risks of the study intervention compared to the risks a patient would run if treated in routine practice This approach was first proposed in 2009 and later adapted by other stakeholders such as the Organization for Economic Co-operation and Development (OECD), the U.S Food and Drug Agency (FDA), and EMA [9, 12, 13]. The approach taken may be evaluated as overcautious at best, and at worst, a complete waste of resources based on current reviews [18, 19]

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