Designing and conducting randomized controlled trials in palliative care: A summary of discussions from the 2010 clinical research forum of the Australian Palliative Care Clinical Studies Collaborative

Tania Shelby-James, Janet Hardy, Meera Agar, Patsy Yates, Geoffrey Mitchell, Christine Sanderson, Tim Luckett, Amy Abernethy, David Currow

    Research output: Contribution to journalArticle

    26 Citations (Scopus)

    Abstract

    Rigorous clinical research in palliative care is challenging but achievable. Trial participants are likely to have deteriorating performance status, co-morbidities and progressive disease. It is difficult to recruit patients, and attrition unrelated to the intervention being trialled is high. The aim of this paper is to highlight practical considerations from a forum held to discuss these issues by active palliative care clinical researchers.To date, the Australian Palliative Care Clinical Studies Collaborative (PaCCSC) has randomized more than 500 participants across 12 sites in 8 Phase III studies. Insights from the 2010 clinical research forum of the PaCCSC are reported. All active Australian researchers in palliative care were invited to present their current research and address three specific questions: (1) What has worked well? (2) What didn't work well? and (3) How should the research be done differently next time?Fourteen studies were presented, including six double-blind, randomized, controlled, multi-site trials run by the PaCCSC. Key recommendations are reported, including guidance on design; methodologies; and strategies for maximizing recruitment and retention. These recommendations will help to inform future trial design and conduct in palliative care.

    Original languageEnglish
    Pages (from-to)1042-1047
    Number of pages6
    JournalPalliative Medicine
    Volume26
    Issue number8
    DOIs
    Publication statusPublished - 1 Dec 2012

    Keywords

    • Clinical trials methodology
    • palliative care
    • participant recruitment
    • phase III trials
    • randomized controlled trials

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