Getting the numbers: Clinical trials in palliative care

Clinical medicine is informed by a number of traditions: important among these are the learnings drawn from randomized clinical trials. We may surmise that a new treatment will be effective, but the patient is the teacher, and there is an ethical imperative to carefully monitor the effects of a given treatment.  But what of trials among terminally ill patients, receiving palliative care?

Randomized controlled trials have been considered to be the gold standard for research evidence within clinical medicine for many years. While this approach is not short of critics, clinical trials remain a key method for maintaining public confidence in the evidence base supporting clinical medicine. Recently, attention has been drawn to the observation that patients who are on clinical trials tend to ‘do better’ than those who are not; even if allocated to the control condition! This has led to greater public interest in enrolling as participants in clinical trials.

However, for researchers aiming to study the impact of innovative palliative care treatments, recruiting sufficient numbers of patients, and achieving adequate rates of patient follow-up remains a challenge. The short life expectancy, symptom burden and prevalence of delirium among palliative care patients leads to a range of ethical concerns about their recruitment into clinical trials. Many hospitals have only small palliative care units, and struggle to recruit patients due to low numbers of eligible patients, and a protective attitude among family carers.

Advocates for research would argue for the necessity of high-quality, adequately-powered clinical trials in palliative care, to meet urgent needs for improvements in symptom management and quality of life among dying patients. One solution has come through collaboration across multiple hospital sites. Clinical trials collaboratives such as the Palliative Care Clinical Studies Collaborative (PaCCSC) and the Improving Palliative Care through Clinical Trials (ImPaCCT) group exist to facilitate the design and implementation of high quality clinical trials in palliative care, and collaborative recruitment across groups of sites. Recent publications have trialled innovative approaches, including social marketing principles, to achieve higher recruitment rates onto palliative care trials (Le Blanc et al Amer. Soc. Clin. Oncol; Nov 2013:277-282). Perhaps we can foresee a future in which a culture of supporting high quality clinical trials will contribute to ongoing development of clinical practice in palliative care.

Craig Sinclair @craigbsinclair

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