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Invited Commentary
July 2016

Informative Neutral Studies Matter—Why the Targeting Inflammation With Salsalate in Cardiovascular Disease (TINSAL-CVD) Trial Deserves Our Attention

Author Affiliations
  • 1Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
JAMA Cardiol. 2016;1(4):423-424. doi:10.1001/jamacardio.2016.0604

Clinical research requires a fundamental state of equipoise allowing the physician responsible for care to state with assurance to a potential trial participant that the best treatment alternative is unknown, that an important but untested hypothesis has been raised in the scientific community, and that the only way to address validity of the hypothesis is to perform a randomized, placebo-controlled clinical trial in which the therapy of interest is determined by random allocation. This covenant between physician and patient is a delicate one because, if true scientific equipoise exists, roughly half of all trials will be neutral. In a survey of 104 contemporary trials funded by not-for-profit agencies between 2000 and 2005, 49% reported evidence favoring new treatments over standard of care, whereas 51% did not.1 Yet, when a well-conducted trial is based on solid pathophysiologic principles, neutral outcomes can be highly informative.