Clinical Trials in palliative care: do we keep our patients safe?

Presented by Linda Brown

The Australian Palliative Care Clinical Studies Collaborative (PaCCSC) has been conducting clinical trials since 2006 to build the evidence base for medications commonly used in palliative care. In keeping with international regulations, PaCCSC trials routinely monitor the safety of participants, as a result of their participation. Palliative care trials have been said to be unnecessarily burdensome, potentially harmful and ethically questionable for participants. The number and quality of trials conducted by PaCCSC  provide the palliative care community with valuable evidence to underpin clinical decision making and importantly for future referral of patients to clinical trials.

Comprehensive information was collected from all trial participants from 5 phase III clinical trials was collected and combined to determine if any adverse events (or harms) were likely to have been caused by trial participation. All harms, irrespective of degree of severity, and the allocation to active or placebo intervention, across all stages of each trial, were tabulated and assigned an attribution to the trial intervention.

Every participant randomised to the 5 trials was included in the analysis, 1289 participants contributed to 21,000 individual adverse event records, across 16 clinical sites in Australia. All harms from the time of initial assessment to trial exit were included. The results will be presented as a cohort, and by individual trial.

Irrespective of the overall results of the clinical trials themselves, this analysis enables the true treatment emergent adverse events of 5 high quality, adequately powered randomised clinical trials to be examined, and to answer the question: do we harm our patients when they participate in a well-designed clinical trial?