Statistical Challenges in the Design and Analyses of Clinical Trials in Solid Organ Transplantation
*LaRee Ann Tracy, FDA/CDER/OB/DB4 Keywords: solid organ tranplantation, immunosuppressant, clinical trial issues The evolution and improvement of immunosuppressive regimens in organ transplantation has led to improved patient and graft survival rates and reduced rates of acute rejection; however, these improvements may be leading to greater incidence of severe adverse events, such as infections, nephrotoxicity and diabetes. The evaluation of new regimens therefore requires detailed risk/benefit analyses and consideration of more relevant clinical outcomes. Additionally, there is tremendous variation in treatment combinations, doses, and concentration monitoring leading to challenges in designing and interpreting active-controlled clinical trials. Lastly, recent failures of confirmatory clinical trials have raised concern regarding the absence of sufficient phase II dose-finding. This talk will outline the critical issues surrounding clinical trials in organ transplantation with case examples.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC