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About Randomized Clinical Trials Related to Lipoproteins in Diabetes Mellitus

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Lipoproteins in Diabetes Mellitus

Part of the book series: Contemporary Diabetes ((CDI))

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Abstract

The results of randomized controlled clinical trials in humans provide robust evidence to guide clinical practice. Such trials related to the treatment of lipoprotein levels in people with diabetes mellitus have contributed to clinical practice guidelines and to improved clinical outcomes observed in recent years. Randomized controlled trials (RCTs) are often suggested and informed by epidemiology, cross-sectional studies, and preclinical studies, and their results can also guide novel basic science research. RCTs are major undertakings in effort, time, and cost; hence, their careful design, conduct, and interpretation are important. Terms such as the phases of clinical research, types of statistical errors, and Hawthorne effect are defined. Novel types of trial design are described. Important study design issues such as subject selection, sample size and randomization, choice of study end points, and potential confounding effects of metabolic memory and drug pleiotropic effects are also considered. References to major sources of further information are also provided in this chapter.

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Acknowledgements

The Clinical Trials Centre is partly supported by funding from the Australian National Health and Medical Research Council. ACK and AJJ are supported by NHMRC Fellowships.

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Authors and Affiliations

  1. NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia

    Anthony Keech, Alicia J. Jenkins, Val Gebski & Ian Marschner

  2. Diabetes and Vascular Medicine, Baker Heart and Diabetes Institute, Melbourne, VIC, Australia

    Alicia J. Jenkins

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  1. Anthony Keech
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  4. Ian Marschner
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Correspondence to Ian Marschner .

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Editors and Affiliations

  1. NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia

    Alicia J. Jenkins

  2. Department of Medicine, Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, MD, USA

    Peter P. Toth

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Keech, A., Jenkins, A.J., Gebski, V., Marschner, I. (2023). About Randomized Clinical Trials Related to Lipoproteins in Diabetes Mellitus. In: Jenkins, A.J., Toth, P.P. (eds) Lipoproteins in Diabetes Mellitus. Contemporary Diabetes. Humana, Cham. https://doi.org/10.1007/978-3-031-26681-2_20

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