Delivering clinical trials at home: protocol, design and implementation of a direct-to-family paediatric lupus trial.

ABSTRACT:

Introduction

Direct-to-family clinical trials efficiently provide data while reducing the participation burden for children and their families. Although these trials can offer significant advantages over traditional clinical trials, the process of designing and implementing direct-to-family studies is poorly defined, especially in children with rheumatic disease. This paper provides lessons learnt from the design and implementation of a self-controlled, direct-to-family pilot trial aimed to evaluate the effects of a medication management device on adherence to hydroxychloroquine in paediatric SLE.

Methods

Several design features accommodate a direct-to-family approach. Participants meeting eligibility criteria from across the USA were identified a priori through a disease re

SUBMITTER: Randell RL 

PROVIDER: S-EPMC8108689 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature