Implementing the Trial Protocol

Jamie B. Oughton () and Amanda Lilley-Kelly ()
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Jamie B. Oughton: University of Leeds, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research
Amanda Lilley-Kelly: University of Leeds, Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research

Chapter 14 in Principles and Practice of Clinical Trials, 2022, pp 239-255 from Springer

Abstract: Abstract This chapter outlines the steps required to bring a protocol to life as a clinical trial. Developing the protocol is a multidisciplinary effort which must be approached in an ordered and logical way with clear leadership. Poor site feasibility is a common reason for trial failure when performed badly and is crucial to capture a generalizable population. The key site feasibility assessment issues are outlined. The chapter goes on to give advice on data collection and how this should be planned alongside developing the trial protocol. Trial processes must be adequately described and trial staff trained well to maximize efficiency and minimize error. Strategies to identify and mitigate risks to participant safety and trial integrity are discussed along with techniques that can be implemented to monitor the identified risks. Typical trial oversight groups and processes are provided to reach a structure that is effective and proportionate to the level of trial risk. Finally, suggestions for how to manage trial promotion to maximize engagement with investigators, potential participants and other stakeholders are discussed.

Keywords: Protocol; Feasibility; Monitoring; Oversight; Publicity; Training program; Competency (search for similar items in EconPapers)
Date: 2022
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DOI: 10.1007/978-3-319-52636-2_37

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