SPIRIT 2013 protocol checklist released | Regulatory Doctor
An international group has produced comprehensive protocol guidelines, called SPIRIT 2013, or Standard Protocol Items: Recommendations for Interventional Trials, which were recently published in Annals of Internal Medicine. SPIRIT 2013 describes 33 items that should be included in a clinical trial protocol, which is the written plan for a clinical trial. A variety of stakeholders including trial investigators, physicians, statisticians, medical journal editors, and others have worked together since 2007 on the project. The group has also published a paper in BMJ that explains each item on the checklist and offers detailed examples.
Currently, many study protocols lack one or more pieces of information when first submitted to an Institutional Review Board (IRB) for approval. An incomplete protocol can lead to confusion, lack of consistency, time wasted on amendments and corrections, and delay in signing up participants. It can also make it difficult for outside individuals or organizations to understand and evaluate the trial. In the worst case, incomplete or confusing protocols result in studies that produce unreliable data. High-quality protocols, on the other hand, can save time and money, do a better job of protecting the rights and safety of the participants, and produce better data.
SPIRIT 2013 is intended to help produce complete protocols, not how to design clinical trials; however, it may prove helpful during the planning process by providing a detailed list of everything that needs to be described in the protocol.
SPIRIT 2013 has been endorsed by Annals of Internal Medicine, BMJ, GlaxoSmithKline, and The Lancet, among others.