SPIRIT 2013: new guidance for content of clinical trial protocols

Cet article présente la mise à jour 2013 des recommandations "SPIRIT" pour la rédaction de protocoles d'essais cliniques

Résumé en anglais

The protocol is an important document that details the background, methods, ethical considerations, and administration of a clinical trial. The information contained in the protocol is useful for several groups. For those involved in the trial, the protocol provides the information needed for the study to be implemented consistently across collaborators in a way that mirrors the intentions of the principal investigators. For external groups who review the trial, such as research ethics committees (REC), funders, regulators, journal editors, potential participants, health-care providers, and systematic reviewers, the protocol provides a window into the nature and quality of the study plans and subsequent amendments. The protocol also allows for an assessment of consistency between the final report and the original intent...