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.
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Chen, B.E., Urton, A., Sadura, A., Parulekar, W.R. (2020). Principles of Protocol Development. In: Piantadosi, S., Meinert, C. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52677-5_32-1
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DOI: https://doi.org/10.1007/978-3-319-52677-5_32-1
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