Inadequate and poor-quality outcome reporting in transplant clinical trials is a known barrier that impedes the ability of researchers to evaluate, replicate, synthesize, and build upon study findings and impacts evidence-based decision-making by patients, clinicians, and policy-makers. Using cardiovascular disease as an example, we will discuss and examine a set of evidence-informed and consensus-based standards focused on outcome reporting in clinical trials that can be applied across all solid organ transplantation.
“This Masterclass has been accredited by the European Accreditation Council for Continuing Medical Education (EACCME®) with 1 European CME credits (ECMEC®s). Each medical specialist should claim only those hours of credit that he/she actually spent in the educational activity.”Attendance to the live Masterclass and the completion of the post-event survey are mandatory to receive the certificate and CME credits.
“Through an agreement between the Union Européenne des Médecins Spécialistes and the American Medical Association, physicians may convert EACCME® credits to an equivalent number of AMA PRA Category 1 CreditsTM. Information on the process to convert EACCME® credit to AMA credit can be found at www.ama-assn.org/education/earn-credit-participation-international-activities.
“Live educational activities, occurring outside of Canada, recognised by the UEMS-EACCME® for ECMEC®s are deemed to be Accredited Group Learning Activities (Section 1) as defined by the Maintenance of Certification Program of the Royal College of Physicians and Surgeons of Canada.”
Professor of Medicine
University of British Columbia
Division of Nephrology
Saint Paul’s Hospital
John S. Gill MD, MS, FRCPC, Fellow of American Society of Transplantation
John Gill is Professor of Medicine with tenure at the University of British Columbia, Division of Nephrology, Saint Paul’s Hospital.
John’s research includes clinical outcomes in kidney transplantation, access to care, clinical trials, health services research, implementation science and research ethics.
John is President Elect of the American Society of Transplantation, Consulting Editor of the American Journal of Transplantation, Associate Editor of the Journal of the American Society and Member of the Declaration of Istanbul Custodial Group. He serves on several national committees related to organ donation and transplantation in Canada.
Dr Gill currently serves on the Expert Advisory Panel of the United States Renal Data System and the External Expert Panel of the NIH Apollo Study. John is Consulting Editor for the American Journal of Transplantation and Associate Editor of the Journal of the American Society of Nephrology. John is President-elect of the American Society of Transplantation and is also a member of several national working groups to advance care for transplant recipients in Canada.
Jonathan C. Craig
Vice-President and Executive Dean
College of Medicine and Public Health
Matthew Flinders Distinguished Professor
Professor Craig is Vice-President and Executive Dean of the College of Medicine and Public Health and a Matthew Flinders Distinguished Professor. He is a practising paediatric nephrologist and clinical epidemiologist, and especially committed to improving the health of people with chronic kidney disease, the health of children, and the health and well-being of Indigenous people.
His awards include Fellow of the Australian Academy of Health and Medical Sciences, International Distinguished Medal of the National (US) Kidney Foundation (2010), TJ Neale Award for Outstanding Contribution to Nephrological Science (2009), and Honorary Membership of the Italian Society of Nephrology (2004). He is the Coordinating Editor of the Cochrane Kidney and Transplant Group, immediate past-President of the Australia-New Zealand Society of Nephrology, and Director of the Evidence-Review Team for KDIGO guidelines (diabetes, blood pressure and glomerular disease)
He is a past Chair of the Steering Group of Cochrane, is a member of the Pharmaceutical Benefits Advisory Committee for the Australian Government, a member of the Medicare Services Advisory Committee, a member of the Life Savings Drug Program, a member of the International Advisory Panel for Singapore’s Agency for Care Effectiveness, and past member of the WHO expert review panel for global strategy and plan of action on public health, innovation and intellectual property.
He has published > 830 papers across the spectrum of chronic kidney disease, and methodological work, which have been cited > 43,000 (h-index 92).
Principal Research Fellow
Sydney School of Public Health
The University of Sydney
Professor Allison Tong is a Principal Research Fellow at the Sydney School of Public Health, The University of Sydney. She holds an Australian National Health and Medical Research Council (NHMRC) Investigator Award. She has experience in patient-centred outcomes research in chronic disease, particularly chronic kidney disease. Allison has an interest in patient involvement in research, including in the context of research priority setting, the development of core outcomes for research, and in the co-production of clinical trials. She co-founded and is on the Executive Committee of the global Standardised Outcomes in Nephrology (SONG) Initiative, which aims to establish consensus-based core outcomes across the spectrum of chronic kidney disease. She established the Patient-Centred Research Network (PACER) network, which aims to facilitate knowledge exchange, cross-disciplinary collaboration, and innovation in conducting and implementing patient-centred outcomes research and patient involvement in research.
Presentation: Defining cardiovascular outcomes in transplantation and the implications for trials design, John Gill, Canada
Live Q&A with John Gill, Canada
Presentation: Transparency in outcomes reporting clinical trials in transplantation, Jonathan C. Craig, Australia
Presentation: Patient engagement and transparency in outcomes reporting in transplantation, Allison Tong, Australia
Masterclass closing remarks