Tackling the Challenges of Clinical Trials in Palliative Care

  title={Tackling the Challenges of Clinical Trials in Palliative Care},
  author={David Christopher Currow and Meera R. Agar and Amy P. Abernethy},
  journal={Pharmaceutical Medicine},
There is an ethical imperative to provide the best quality of care for all people, including people at the end of life. In order to provide such care, each intervention used in clinical practice must be tested objectively for net clinical benefit (response and toxicity). For pharmacological and non-pharmacological interventions, the gold standard of evidence remains a phase III randomized, controlled study. In palliative care, there is a gradually emerging evidence base for clinical practice… Expand
Outcome measures for palliative care research
The current state of the science in physical symptoms and other end-of-life care domains and/or illness-specific outcomes in palliative care is summarized to allow consolidation of outcome measurement and the ability to extend measurement from the clinical trial setting into routine clinical practice. Expand
Improving the evidence base in palliative care to inform practice and policy: thinking outside the box.
This narrative review explores the debate about the use of current evidence-based approaches for conducting research, such as randomized controlled trials and other study designs, in palliative care, and describes key myths about palliatives care research to highlight substantive challenges and propose specific strategies to address some of these challenges. Expand
An examination of the research priorities for a hospice service in New Zealand: A Delphi study
The study generated a rich set of research themes and specific research topics, in spite of the recognition by all concerned that palliative care services work within a philosophy of patient-centered care. Expand
Validation of the Phase II Feasibility Study in a Palliative Care Setting
This study validates the use of the phase II feasibility study to assess protocol viability in a palliative population prior to embarking on a larger trial. Expand
Should end-of-life patients be enrolled as participants in clinical research? A best-fit framework synthesis.
This review provides up-to-date evidence on key challenges and ethical considerations about researching with end-of-life patients and important recommendations for clinicians, research, and ethics committee members when evaluating clinical research with people at their end of life. Expand
Gaps in the evidence base of opioids for refractory breathlessness. A future work plan?
The current understanding of opioids for treating breathlessness, what is still unknown as priorities for future research, and methodological issues for consideration in planned studies are presented. Expand
Clinical hypnosis for palliative care in severe chronic diseases: a review and the procedures for relieving physical, psychological and spiritual symptoms.
A scientific review of representative studies recognizing how clinical hypnosis in medicine is an effective complementary therapy, for pain and symptom's relief in severe chronic diseases and in palliative care is reviewed. Expand


Implementing palliative care studies.
Implementation considerations are intimately related to the architecture of a specific trial and should be addressed practically and early in the design phase of any randomized trial addressing a palliative care question. Expand
Letter to the editor: Multi-site research allows adequately powered palliative care trials; web-based data management makes it achievable today
There have been concerns expressed about the vulnerability of people with life-limiting illnesses being asked to participate in clinical studies, but the evidence is that people want to actively participate in studies that focus on relevant interventions that may directly improve the clinical care offered. Expand
Evaluation of a palliative care service: problems and pitfalls
In designing evaluations of palliative care services, investigators should be prepared to deal with the following issues: attrition due to early death, opposition to randomisation by patients and referral sources, ethical problems raised by randomisation of dying patients, the appropriate timing of comparison points, and difficulties of collecting data from sick or exhausted patients and care givers. Expand
Prioritising drugs for single patient (n-of-1) trials in palliative care
Single patient trials (SPTs) offer a potential means of obtaining the evidence necessary to support or refute the use of several of the drugs and interventions whose use is currently based on physician experience or anecdote alone. Expand
A framework for generalizability in palliative care.
This article provides a suggested framework for classifying palliative care research subpopulations and the clinical sub Populations to which the research findings are being applied to improve the ability of clinicians, health planners, and funders to interpret and apply palliatives care research in real-world settings. Expand
Improving the evidence base in palliative medicine: a moral imperative
  • P. Keeley
  • Medicine
  • Journal of Medical Ethics
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The current state of the evidence base of effectiveness in palliative care leads us to the uncomfortable position where patients are in precisely the position of being unwitting participants in “n of 1” clinical trials by default, without their explicit consent. Expand
Methodologic issues in effectiveness research on palliative cancer care: a systematic review.
Effectiveness research in palliative care is complex and has many pitfalls and it is a challenge for future research to link patient outcomes to the quality of care, independent from the autonomous course of the disease and from personal characteristics. Expand
Planning phase III multi-site clinical trials in palliative care: the role of consecutive cohort audits to identify potential participant populations
These data provide a baseline estimate of potential people to approach about clinical trials in supportive care but do not account for clinician ‘gate-keeping’, lack of interest in participating nor withdrawal from the study once initiated. Expand
Research in End-of-Life Settings: An Ethical Inquiry
The authors conclude that barriers to palliative care research are surmountable, and that the “research imperative” and principles laid out in the Belmont Report of 1979 require us to rigorously study clinical interventions used for palliatives care patients—so as to provide optimal safety and outcomes for present and future patients. Expand
A survey of the views of palliative care healthcare professionals towards referring cancer patients to participate in randomized controlled trials in palliative care
An unwillingness on the part of many HCPs to refer patients for RCTs in PC is revealed and trial-related factors that may encourage or discourage referral are identified, including previous research experience and male gender. Expand