Trial design and endpoints in clinical transplant research

Abstract

* These two authors contributed equally to the research and preparation of this review. SUMMARYThe 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.

Research priority setting in organ transplantation: a systematic review

“…Death with a functioning graft due cardiovascular disease, infection, cancer, and diabetes , the debilitating side‐effects of immunosuppression, and the severe shortage of transplantable organs are some of the major hurdles to the overall success of transplantation. In view of these broad‐ranging complexities and unresolved challenges in transplantation, progress may be achieved through strategic and transparent prioritization of research to strengthen the legitimacy, efficiency, and relevance of research .…”

Does renal transplant in children with LUTD improve their bladder function?

“…Most studies discussed graft function as the focus of the research and did not refer to the history of LUTD under renal graft over time. Such changes are still vague and should account for more than a small percentage of graft function 2 . Therefore; we aimed at evaluation of the LUT function after RT into patients with LUTD.…”

Lebertransplantation beim hepatisch metastasierten kolorektalen Karzinom: aktuelle Datenlage und mögliche Zukunftsszenarien

“…Hier werden 2027 erste Ergebnisse erwartet [8]. Auch wenn aus wissenschaftlicher Sicht die Randomisierung sicher dem Goldstandard entspricht, ist diese bei NRCRM schwierig [27]. Die zunehmend guten Ergebnisse suggerieren einen Überlebensvorteil für diese Patienten durch eine LTX.…”