Introduction to Feasibility Trials

IntroductionPilot and feasibility trials are conducted to determine feasibility or to collect information that would inform the design of a larger definitive trial.

Publishing protocols of trials including protocols of pilot and feasibility trials—designed to inform the designs of main trials—has been advocated as an important strategy towards improving transparency in the conduct and reporting of main trials and pilot/feasibility trials.

The website was developed by the Pilot and Feasibility Studies collaboration who developed the CONSORT Extension to Pilot and Feasibility Trials as a resource to help triallists and researchers perform well conducted pilot and feasibility studies.

Introduction Pilot and feasibility trials aim to test whether a full trial can be conducted or if any procedures must be changed for the full trial.

However, in the clinical setting information is limited to a small number of feasibility trials.

Most studies were feasibility trials and only five were pivotal trials, including the ones used for recent FDA approval.

Conclusions: Patient feedback allowed us to refine our intervention strategy prior to running costly feasibility trials.

The goal of the current special issue is to provide a snapshot of the progress toward the three objectives above, and to coordinate with a companion issue of Clinical Practice in Pediatric Psychology, which highlights both feasibility trials and specific clinicallyfocused translational or dissemination work.

Here, we follow the 10-year evolution of one system, the UVA AP, through inpatient studies, short-term outpatient feasibility trials, and long-term free-living safety tests.

Over recent years, multiple feasibility trials have demonstrated the clinical prospects of MP.

We applaud the Journal of Human Lactation for fighting against this bias by publishing our results, in which we present an unbiased description of the barriers that we encountered (and what others can expect to encounter) in conducting a rigorous pilot study following consensus guidelines for publication of randomized pilot and feasibility trials (SM Eldridge, BMJ 2016;355:i5239).

There is a need for feasibility trials of digital interventions to determine the usage and acceptability of interventions.

The publication in 2016 of the CONSORT extension to pilot and feasibility trials filled a much-needed gap, but there still remains some uncertainty as to how to report pilot and feasibility studies that are not randomised.