About half of clinical trial protocols lack key information when first submitted for research ethics board (REB) approval. An incomplete protocol impedes transparency and makes it difficult for REBs and other reviewers to understand the trial – leading to time wasted on protocol revisions, and delays in approval and enrolling participants. One third of protocol amendments can be avoided with greater attention to protocol content, saving an average of 6-16 weeks in delays and 4 hours of REB time per trial. Incomplete protocols can also lead to inconsistent trial conduct and in the worst case, trials that produce invalid data.
To address these concerns, the SPIRIT Initiative (Standard Protocol Items: Recommendations for Interventional Trials) developed evidence-based guidance for the content of trial protocols. Published in Annals of Internal Medicine, BMJ, and Lancet, SPIRIT aims to provide high-quality standards for trial protocols, while helping to streamline the process from protocol development to REB approval. High-quality protocols can promote transparency, do a better job of protecting trial participants, and help the trial meet its objectives with rigour and efficiency.
Co-funded by the Canadian Institutes of Health Research, National Cancer Institute of Canada, and Canadian Agency for Drugs and Technologies in Health, the SPIRIT group of experts used established methods for developing reporting guidelines, including two systematic reviews; a Delphi consensus process with three survey rounds (96 participants from 17 countries); 2 consensus meetings (19 participants); and a knowledge translation meeting. The SPIRIT 2013 guidance consists of a 33-item checklist and an accompanying Explanation and Elaboration paper that provides the rationale and evidence supporting each recommended protocol item, along with model examples from actual protocols. A web-based implementation tool called SEPTRE (SPIRIT Electronic Protocol Tool & Resource) is also under development to make protocol creation and management easier and more efficient.