Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2022 Jan 29:26:100897.
doi: 10.1016/j.conctc.2022.100897. eCollection 2022 Apr.

Factors influencing the statistical planning, design, conduct, analysis and reporting of trials in health care: A systematic review

Marina Zaki  1   2 , Lydia O'Sullivan  2   3 , Declan Devane  2   4   5 , Ricardo Segurado  6 , Eilish McAuliffe  1
Affiliations
Review

Factors influencing the statistical planning, design, conduct, analysis and reporting of trials in health care: A systematic review

Marina Zaki et al. Contemp Clin Trials Commun. .

Abstract

Background: Trials in health care are prospective human research studies designed to test the effectiveness and safety of health care interventions, such as medications, surgeries, medical devices and other treatment or prevention interventions. Statistics is an important and powerful tool in trials. Inappropriately designed trials and/or inappropriate statistical analysis produce unreliable results and a lack of transparency when reported, with limited clinical use.

Aim: This systematic literature review aimed to identify, describe and synthesise factors contributing to or influencing the statistical planning, design, conduct, analysis and reporting of trials.

Methods: Information sources were retrieved from the following electronic citation databases: PubMed, Web of Science, PsycINFO, and CINAHL and the grey literature repository: OpenGrey. 90 articles and guidelines were included in this review. A narrative, thematic synthesis identified the key factors influencing the statistical planning, design, conduct, analysis and reporting of trials in health care.

Findings and conclusion: We identified three analytical themes within which factors are grouped. These are: "what makes a statistician?", "the need for dynamic statistical involvement and collaboration throughout a trial - it's not just about the numbers", "and the "accountability of statisticians in ensuring the safety of trial participants and the integrity of trial data". While important insights emerged about the qualifications, training, roles, and responsibilities of statisticians and their collaboration with other team members in a trial, further empirical research is warranted to elicit the perceptions of trial team members at the centre of statistics in trials.

Keywords: Cumulative Index to Nursing and Allied Health Literature, (CINAHL); Joanna Briggs Institute, (JBI); Principal Investigators, (PI); Statistics; Systematic review; Trials; World Health Organisation, (WHO).

PubMed Disclaimer

Conflict of interest statement

☒ The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. ☐The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:

Figures

Fig. 1
Fig. 1
PRISMA flow diagram.
Fig. 2
Fig. 2
Schematic describing the analytical themes extracted from the literature.
See this image and copyright information in PMC

References

    1. Merriam-Webster Dictionary https://www.merriam-webster.com/dictionary/statistics Available from: Accessed on: 20.05.2020.
    1. Peace K.E., Chen D.-G., editors. Clinical Trials Methodology. first ed. Taylor and Francis; New York: 2020.
    1. Stewart D. Making the difference (online blog) 2020. https://involveddotblog.wordpress.com/2020/03/24/what-is-trials-methodol... [15th June 2021]. Available from:
    1. Adams-Huet B., Ahn C. Bridging clinical investigators and statisticians: writing the statistical methodology for a research proposal. J. Invest. Med.: the official publication of the American Federation for Clinical Research. 2009;57(8):818–824. - PMC - PubMed
    1. Zaki M., Galligan M., O'Sullivan L., et al. A protocol for a systematic review investigating the factors influencing the statistical planning, design, conduct, analysis and reporting of trials [version 2; peer review: 2 approved] HRB Open Res. 2020;3:36. - PMC - PubMed

Further reading section

    1. Atici E., Erdemir A.D. Ethics in a scientific approach: the importance of the biostatistician in research ethics committees. J. Med. Ethics. 2008;34(4):297–300. - PubMed
    1. Calis K.A., Archdeacon P., Bain, et al. Understanding the functions and operations of data monitoring committees: survey and focus group findings. Clin. Trials. 2016;14(1):59–66. - PubMed
    1. Delgado-Rodriguez M., Ruiz-Canela M., De Irala-Estevez J., et al. Participation of epidemiologists and/or biostatisticians and methodological quality of published controlled clinical trials. JECH. 2001;55(8):569–572. - PMC - PubMed
    1. Demotes-Mainard J., Chêne G., Libersa C., Pignon J.P. Clinical research infrastructures and networks in France: report on the French ECRIN workshop. Therapie. 2005;60(2):183–199. - PubMed
    1. Dhar S.K., Kianifard F. Teaching statistics to clinical research staff in a pharmaceutical company. Pharmaceut. Stat. 2006;5(3):225–229. - PubMed