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  • Relevance of randomised controlled trials in oncology [Elektronski vir]
    Tannock, Ian F. ...
    Well-designed randomised controlled trials (RCTs) can prevent bias in the comparison of treatments and provide a sound basis for changes in clinical practice. However, the design and reporting of ... many RCTs can render their results of little relevance to clinical practice. In this Personal View, we discuss the limitations of RCT data and suggest some ways to improve the clinical relevance of RCTs in the everyday management of patients with cancer. RCTs should ask questions of clinical rather than commercial interest, avoid non-validated surrogate endpoints in registration trials, and have entry criteria that allow inclusion of all patients who are fit to receive treatment. Furthermore, RCTs should be reported with complete accounting of frequency and management of toxicities, and with strict guidelines to ensure freedom from bias. Premature reporting of results should be avoided. The bar for clinical benefit should be raised for drug registration, which should require publication and review of mature data from RCTs, post-marketing health outcome studies, and value-based pricing.
    Source: Lancet oncology [Elektronski vir]. - ISSN 1474-5488 (Vol. 17, iss. 12, Dec. 2016, str. e560-e567)
    Type of material - e-article
    Publish date - 2016
    Language - english
    COBISS.SI-ID - 2535803

    Link(s):

    http://www.sciencedirect.com/science/article/pii/S1470204516305721
    DOI

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