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The protocol for a randomised controlled trial (RCT) pre‐specifies all facets of the research plan and thereby promotes consistency of trial implementation, the reproducibility of its findings, and adherence to ethical standards and regulatory requirements. 

The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement provides clear guidance regarding the elements of an appropriate protocol, and a summarised subset of this content is recorded when prospectively registering a trial. Trial registration is now a prerequisite for institutional ethics approval and for the publication of clinical trial findings in many journals.

Adherence to the protocol is important for protecting the scientific integrity of a trial from decisions that may introduce bias if inappropriately informed by unblinded outcomes data; that is, with knowledge of how the treatment effect estimate is influenced by the change. In practice, adherence to protocols and the documentation of changes has been unsatisfactory. 

This MJA research article shares more.

Learning Outcomes

1. Explain key components of the research
2. List main findings
3. Recognise the importance for adherence to protocols and documentation of changes in research plans in response to the research.

Details

Authors: Xanthi Coskinas, R John Simes and Andrew J Martin

Article Type: Research