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Principles of Protocol Development

In: Principles and Practice of Clinical Trials

Author

Listed:
  • 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)

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.

Suggested Citation

  • Bingshu E. Chen & Alison Urton & Anna Sadura & Wendy R. Parulekar, 2022. "Principles of Protocol Development," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 10, pages 151-168, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_32
    DOI: 10.1007/978-3-319-52636-2_32
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