An introduction to clinical trial design

A Schultz; B R Saville; J A Marsh; T L Snelling

doi:10.1016/j.prrv.2019.06.002

An introduction to clinical trial design

Paediatr Respir Rev. 2019 Nov:32:30-35. doi: 10.1016/j.prrv.2019.06.002. Epub 2019 Jun 26.

Authors

A Schultz¹, B R Saville², J A Marsh³, T L Snelling⁴

Affiliations

¹ Faculty of Health and Medical Sciences, University of Western Australia Medical School, Crawley, Australia; Department of Respiratory Medicine, Perth Children's Hospital, Nedlands, Australia; Wesfarmers Centre of Vaccines & Infectious Diseases, Telethon Kids Institute, University of Western Australia, Nedlands, Australia. Electronic address: andre.schultz@health.wa.gov.au.
² Berry Consultants, Austin, USA; Vanderbilt University, Department of Biostatistics, Nashville, TN, USA.
³ Wesfarmers Centre of Vaccines & Infectious Diseases, Telethon Kids Institute, University of Western Australia, Nedlands, Australia; School of Population & Global Health, University of Western Australia, Nedlands, Australia.
⁴ Wesfarmers Centre of Vaccines & Infectious Diseases, Telethon Kids Institute, University of Western Australia, Nedlands, Australia; School of Public Health, Curtin University, Bentley, Australia; Department of Infectious Diseases, Perth Children's Hospital, Nedlands, Australia; Menzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, Australia.

PMID: 31427159
DOI: 10.1016/j.prrv.2019.06.002

Abstract

Clinicians and other decision makers in healthcare use results from clinical trials to inform practice. Interpretation of clinical trial results can be challenging, as weaknesses in trial design, data collection, analysis or reporting, can compromise the usefulness of results. A good working knowledge of clinical trial design is essential to expertly interpret and determine the validity and generalizability of the results. This manuscript will give a brief overview of clinical trial design including the strengths and limitations of various approaches. The focus will be on confirmatory clinical trials.

Keywords: Adaptive trial design; Clinical trial design; Randomisation.

Publication types

Review

MeSH terms

Adaptive Clinical Trials as Topic
Clinical Trials as Topic*
Equivalence Trials as Topic
Humans
Randomized Controlled Trials as Topic
Research Design*