Recommendations from an ESOT-EMA interaction

In 2018, the European Society for Organ Transplantation (ESOT) initiated a Broad Scientific Advice request to the European Medicines Agency (EMA), for updating their Committee for Medicinal Products for Human Use (CHMP) guidelines relating to the development of innovative therapies in the field of kidney transplantation.

The request suggested several options for redefining endpoints used in clinical studies of kidney transplantation. It also proposed study design elements for stratification and subsequent employment of these novel proposals into future clinical trials. The proposed endpoints also aimed to be suitable for the conditional marketing authorization pathway. The EMA subsequently evaluated the discussion document and evidence provided by ESOT, issuing their final recommendations in December 2020.

This supplement to Transplant International provides a detailed summary of key aspects of the proposals and recommendations for definitions of endpoints for clinical trials of kidney transplantation.

Keywords: ESOT, Kidney, Kidney transplant, Kidney transplantation, clinical trials