OCTRU Seminar "SPIRIT 2013 Statement: Defining standard protocol items for clinical trials" Professor Doug Altman

Professor Doug Altman gave a well-attended talk about writing protocols for clinical trials. He presented evidence of wide deficiencies of trial protocols, and frequent important discrepancies between protocols and subsequent journal articles regarding trial methods. He argued that protocols should be publicly available and the desirability of standardising their content. He then discussed the development of evidence-based guidance for completion of clinical trial protocols, published last year as “The SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol”. Considerable background information and examples of good reporting within protocols are contained in the accompanying document “SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials” (www.spirit-statement.org). He gave a brief overview of some of the checklist items in more detail. He finished his talk by introducing the new TIDieR checklist, a guide to better reporting of interventions (http://www.bmj.com/content/348/bmj.g1687).