title: Trial design and endpoints in clinical transplant research.
abstract: The number of clinical trials in solid organ transplantation is progressively increasing year on year, but the quality of design and reporting still varies considerably. The constraints on organ availability, improving short-term outcomes, ethics and timescales involved in organ transplantation present unique challenges for trials in this field. An understanding of the methodology and potential pitfalls in clinical research is essential both to interpret trial results and to design robust studies. This review summarizes the scope and quality of reporting in existing transplant clinical trials and details aspects of clinical trial methodology with particular relevance to transplantation. We highlight initiatives designed to improve the quality of this process to ensure that the results of clinical trials are robust, well reported and of use in everyday clinical practice.
authors.affiliation: Centre for Evidence in Transplantation, Clinical Effectiveness Unit, Royal College of Surgeons of England and the London School of Hygiene and Tropical Medicine, University of London, London, UK.|Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
authors.forename: Simon R
authors.initials: SR
authors.lastname: Knight
authors.affiliation: Centre for Evidence in Transplantation, Clinical Effectiveness Unit, Royal College of Surgeons of England and the London School of Hygiene and Tropical Medicine, University of London, London, UK.|Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Morris
authors.affiliation: Department of Visceral Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.
authors.forename: Stefan
authors.initials: S
authors.lastname: Schneeberger
authors.affiliation: Centre for Evidence in Transplantation, Clinical Effectiveness Unit, Royal College of Surgeons of England and the London School of Hygiene and Tropical Medicine, University of London, London, UK.|Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
authors.forename: Liset H M
authors.initials: LH
authors.lastname: Pengel
mesh_terms: D002986:Clinical Trials as Topic; D023381:Endpoint Determination; D019317:Evidence-Based Medicine; D006085:Graft Survival; D006801:Humans; D016377:Organ Transplantation / Q000639:trends*; D011897:Random Allocation; D012107:Research Design; D013997:Time Factors
keywords: PICO; clinical trials; evidence; outcomes; randomized controlled trial