Abstract
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.
Highlights
Clinical trials are research studies that test the safety and efficacy of novel treatments and interventions
This work is funded and supported by the School of Nursing, Midwifery and Health Systems, University College Dublin, Ireland. The funders of this doctoral research had no role in developing this protocol
There remains a gap in the literature that needs to be addressed; systematically reviewing articles to fully comprehend, collate, and thematically synthesise the factors influencing the statistical aspects of clinical trials is required
Summary
This article is included in the HRB-TMRN gateway. Grant information: Health Research Board Ireland [TMRN-2014-1]. This work is funded and supported by the School of Nursing, Midwifery and Health Systems, University College Dublin, Ireland. The funders of this doctoral research had no role in developing this protocol. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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