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    Statistical methods to derive efficacy estimates of anti-malarials for uncomplicated Plasmodium falciparum malaria: pitfalls and challenges

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    Author
    Dahal, P; Simpson, JA; Dorsey, G; Guerin, PJ; Price, RN; Stepniewska, K
    Date
    2017-10-26
    Source Title
    Malaria Journal
    Publisher
    BMC
    University of Melbourne Author/s
    Simpson, Julie
    Affiliation
    Melbourne School of Population and Global Health
    Metadata
    Show full item record
    Document Type
    Journal Article
    Citations
    Dahal, P., Simpson, J. A., Dorsey, G., Guerin, P. J., Price, R. N. & Stepniewska, K. (2017). Statistical methods to derive efficacy estimates of anti-malarials for uncomplicated Plasmodium falciparum malaria: pitfalls and challenges. MALARIA JOURNAL, 16 (1), https://doi.org/10.1186/s12936-017-2074-7.
    Access Status
    Open Access
    URI
    http://hdl.handle.net/11343/257446
    DOI
    10.1186/s12936-017-2074-7
    Abstract
    The Kaplan-Meier (K-M) method is currently the preferred approach to derive an efficacy estimate from anti-malarial trial data. In this approach event times are assumed to be continuous and estimates are generated on the assumption that there is only one cause of failure. In reality, failures are captured at pre-scheduled time points and patients can fail treatment due to a variety of causes other than the primary endpoint, commonly termed competing risk events. Ignoring these underlying assumptions can potentially distort the derived efficacy estimates and result in misleading conclusions. This review details the evolution of statistical methods used to derive anti-malarial efficacy for uncomplicated Plasmodium falciparum malaria and assesses the limitations of the current practices. Alternative approaches are explored and their implementation is discussed using example data from a large multi-site study.

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