1 40 1 Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Citation List Month Backlog URL Address <a href="http://doi.org/10.1186/1471-2288-10-1" target="_blank" rel="noreferrer">http://doi.org/10.1186/1471-2288-10-1</a> Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource A tutorial on pilot studies: the what, why and how Publisher An entity responsible for making the resource available Bmc Medical Research Methodology Date A point or period of time associated with an event in the lifecycle of the resource 2010 Subject The topic of the resource Humans; Pilot Projects; Randomized Controlled Trials as Topic; Clinical Trials; Research Design/standards; Phase III as Topic/methods Creator An entity primarily responsible for making the resource Thabane L; Ma J; Chu R; Cheng J; Ismaila A; Rios LP; Robson R; Thabane M; Giangregorio L; Goldsmith CH Description An account of the resource Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as "feasibility" or "vanguard" studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1) the general reasons for conducting a pilot study; 2) the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3) the challenges of and misconceptions about pilot studies; 4) the criteria for evaluating the success of a pilot study; 5) frequently asked questions about pilot studies; 7) some ethical aspects related to pilot studies; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format. 2010 Identifier An unambiguous reference to the resource within a given context <a href="http://doi.org/10.1186/1471-2288-10-1" target="_blank" rel="noreferrer">10.1186/1471-2288-10-1</a> Rights Information about rights held in and over the resource Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s). Type The nature or genre of the resource Journal Article 2010 Backlog Bmc Medical Research Methodology Cheng J Chu R Clinical Trials Giangregorio L Goldsmith CH Humans Ismaila A Journal Article Ma J Phase III as Topic/methods Pilot Projects Randomized Controlled Trials as Topic Research Design/standards Rios LP Robson R Thabane L Thabane M