A protocol for a systematic review investigating the factors influencing the statistical planning, design, conduct, analysis and reporting of clinical trials.
Clinical trials
protocol
statistics
systematic review
Journal
HRB open research
ISSN: 2515-4826
Titre abrégé: HRB Open Res
Pays: Ireland
ID NLM: 101754913
Informations de publication
Date de publication:
2020
2020
Historique:
accepted:
02
06
2020
entrez:
3
9
2020
pubmed:
3
9
2020
medline:
3
9
2020
Statut:
epublish
Résumé
Clinical trials can be defined as prospective human research studies to test the effectiveness and safety of interventions, such as medications, surgeries, medical devices and other interventions for the management of patient care. Statistics is an important and powerful tool in clinical trials. Inappropriately designed trials and/or inappropriate statistical analysis produce unreliable results, with limited clinical use. The aim of this systematic literature review is to identify, describe and synthesise factors contributing to or influencing the statistical planning, design, conduct, analysis and reporting of clinical trials. This protocol will describe the methodological approach taken for the following: conducting a systematic and comprehensive search for relevant articles, applying eligibility criteria for the inclusion of such articles, extracting data and information, appraising the quality of the articles, and thematically synthesizing the data to illuminate the key factors influencing statistical aspects of clinical trials.
Identifiants
pubmed: 32875270
doi: 10.12688/hrbopenres.13068.1
pmc: PMC7445680
doi:
Banques de données
figshare
['10.6084/m9.figshare.12264938.v1']
Types de publication
Journal Article
Langues
eng
Pagination
36Informations de copyright
Copyright: © 2020 Zaki M et al.
Déclaration de conflit d'intérêts
No competing interests were disclosed.
Références
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