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Viewpoint |

Pilot Studies A Critical but Potentially Misused Component of Interventional Research

Caroline Kistin, MD, MSc1,2; Michael Silverstein, MD, MPH1,2
[+] Author Affiliations
1Department of Pediatrics, Boston Medical Center, Boston, Massachusetts
2Boston University School of Medicine, Boston, Massachusetts
JAMA. 2015;314(15):1561-1562. doi:10.1001/jama.2015.10962.
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This Viewpoint discusses the goals of pilot studies as precursors to large-scale trials as well as the need for formal guidelines for the conduct and reporting of pilot trials.

Pilot intervention studies, commonly defined as small studies carried out in preparation for larger investigations,1 are essential precursors to high-quality clinical trials. Although not all trials are preceded by pilot investigations, when they are, pilot studies inform how subsequent trials are conducted and have an important role in controlling the pipeline of intervention development and dissemination by influencing which large-scale trials are ultimately carried out and which are never brought to fruition. However, pilot studies have often involved reporting inconsistencies, misapplication of research techniques, and misinterpretation of results, with significant implications for intervention research.13 These suboptimal research practices likely emanate from the understandable but methodologically unsound view of pilot studies as mechanisms to obtain preliminary answers to primary research questions.13 The risks of this approach may include unjustified and potentially misleading conclusions in the short term as well as misinformed decisions about how—and even whether—to proceed to more definitive studies.

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