Principles of Protocol Development

Bingshu E. Chen (), Alison Urton (), Anna Sadura () and Wendy R. Parulekar ()
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Bingshu E. Chen: Queen’s University, Canadian Cancer Trials Group
Alison Urton: Queen’s University, Canadian Cancer Trials Group
Anna Sadura: Queen’s University, Canadian Cancer Trials Group
Wendy R. Parulekar: Queen’s University, Canadian Cancer Trials Group

Chapter 10 in Principles and Practice of Clinical Trials, 2022, pp 151-168 from Springer

Abstract: Abstract Randomized clinical trials are essential to the advancement of clinical care by providing an unbiased estimate of the efficacy of new therapies compared to current standards of care. The protocol document plays a key role during the life cycle of a trial and guides all aspects of trial organization and conduct, data collection, analysis, and publication of results. Several guidance documents are available to assist with protocol generation. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Statement comprises a checklist of essential items for inclusion in a protocol document. Other essential references include those generated by the International Conference on Harmonization and the Declaration of Helsinki which inform the design and conduct of trials that meet the highest scientific, ethical, and safety standards.

Keywords: SPIRIT Statement; International Conference on Harmonization; Declaration of Helsinki (search for similar items in EconPapers)
Date: 2022
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DOI: 10.1007/978-3-319-52636-2_32

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