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Is This a Clinical Trial? And Should It Be Registered?

PTJ strives to improve its processes to enhance readability, simplify manuscript submission for authors, and ensure that only papers with a reasonable likelihood of publication proceed to full review—all with the goal of publishing high-quality, clinically relevant content. In particular, manuscripts reporting clinical trials must be prospectively registered in a publicly accessible trial registry before participant enrollment commences. Although PTJ has required clinical trial registration since 2008, the definition of a clinical trial continues to perplex some authors. Confusion may result in failure to prospectively register a trial, thus preventing PTJ (and many other journals) from publishing the study findings once the study has been completed.

So, what is a clinical trial? The National Institutes of Health (NIH) revised its definition of clinical trials in October 2014 in order to more clearly distinguish between clinical trials and clinical research studies.1 The NIH defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. ”

The NIH considers prospective assignment (which may involve randomization but not necessarily) to be a predefined process specified in a protocol that stipulates the assignment of research participants (individually or …