A tutorial on pilot studies: the what, why and how

Title

A tutorial on pilot studies: the what, why and how

Creator

Thabane L; Ma J; Chu R; Cheng J; Ismaila A; Rios LP; Robson R; Thabane M; Giangregorio L; Goldsmith CH

Publisher

Bmc Medical Research Methodology

Date

2010

Subject

Humans; Pilot Projects; Randomized Controlled Trials as Topic; Clinical Trials; Research Design/standards; Phase III as Topic/methods

Description

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

Rights

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

Journal Article

Citation List Month

Backlog

Citation

Thabane L; Ma J; Chu R; Cheng J; Ismaila A; Rios LP; Robson R; Thabane M; Giangregorio L; Goldsmith CH, “A tutorial on pilot studies: the what, why and how,” Pediatric Palliative Care Library, accessed March 28, 2024, https://pedpalascnetlibrary.omeka.net/items/show/14070.