Webinar: Design of Clinical Trials To Evaluate Platelet Transfusion Efficacy and Safety
Platelet transfusion is an important supportive therapy for critically ill patients. As new methods for collecting, treating and storing platelet components are developed, how should they be evaluated in
Conducting a clinical trial for the evaluation of platelet transfusion efficacy requires that the objective be clear and that relevant endpoints are selected. Which is the best endpoint for this type of trial: count increment, hemostasis, clinical refractoriness, component utilization, transfusion interval? Also, which study design is the most appropriate; comparative, superiority, or non-inferiority?
In this presentation, Nancy Heddle, MSc. and Jeffrey McCullough, MD review a range of issues essential to the successful execution of a platelet clinical trial.
Some of the concepts addressed in this webinar are...
- A review of several trials including TRAP, SPRINT, and SToP. The study designs, data, and interpretations will be discussed
- SPRINT: conventional vs. INTERCEPT platelets (>300 pts/arm)
- SToP: standard vs. half-dose platelets (>800 pts total)
- TRAP: conventional vs. gamma-irradiated platelets (>500 pts)
- Requirements for properly statistically powering a study
- Understanding the PICOT methodology for study design
- Re-evaluating past trial data from new perspectives
Jeffrey McCullough, M.D.
Dr McCullough was the founder and first President of the United States National Marrow Donor Program and for 15 years, he served as Editor of the journal Transfusion. He has chaired multiple national symposia and ad hoc advisory committees to blood bank organizations and has been the recipient of multiple awards recognizing outstanding achievements.
Nancy Heddle, MSc., FCSMLS(D)
Nancy Heddle has a Masters degree in Health Research Methodology from McMaster University and is a distinguished fellow of the Canadian Society of Medical Laboratory Science. She has published over 100 scientific papers, given over 100 national and international presentations, and currently holds significant funding for research in the field of blood transfusion.
In 2005 Nancy became an associate editor of Transfusion and in 2009 was awarded the International Woman in Transfusion Award. She is also the Team Leader, Clinical Studies, BEST Collaborative.