title: Topics in research:  structuring studies in palliative care.
abstract: OBJECTIVE
  This review describes the advances in trial methodology and presents new methodologies to meet some of the challenges of conducting trials in a palliative care setting. To describe why this review is timely and relevant.
  
  
  RESULTS
  This review discusses the process required to conduct trials of complex interventions described by the Britain's Medical Research Council. It discusses the importance of feasibility trials and the quantitative research inherent in these trials. It describes the design alternatives to the classic randomized controlled trials (RCTs), including cluster randomization, step wedge and fast-track randomization, and n-of-1 trial design. The strengths and weaknesses of each are described.
  
  
  CONCLUSIONS
  An understanding of the limitations of RCTs is important. It is important that clinicians and researchers understand the need for alternative trial design and how and when to use them.
authors.affiliation: Cleveland Clinic Lerner School of Medicine, Case Western Reserve University, Cleveland, Ohio, USA. davism6@ccf.org
authors.forename: Mellar P
authors.initials: MP
authors.lastname: Davis
authors.forename: Geoffrey K
authors.initials: GK
authors.lastname: Mitchell
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D005240:Feasibility Studies; D006801:Humans; D010166:Palliative Care; D018579:Patient Selection; D036301:Qualitative Research; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic; D012107:Research Design