News

The traditional large clinical trial, where participants are individually randomized to receive single agents or placebo, continues to hold a central place in nephrology, but the benefits of other trial designs are emerging.

Professor Meg Jardine is director of the NHMRC Clinical Trials Centre and kidney health research team at the University of Sydney, Australia. She has always been interested in clinical trials as a robust way of finding answers to clinical problems. She explains: “Human disease is a hugely complex interplay of genetics, environment, biological compensating and decompensating systems, and treatment effects. Randomization is the best way of overcoming the unconscious assumptions that arise from imperfect knowledge.”

Professor Jardine is interested in response-adaptive techniques (where a trial is adapted based on how patients respond) as a solution to many of the challenges in kidney disease trials. “Treatments and management for kidney disease can involve complex systems, particularly for advanced kidney disease,” she says. “While we know these systems are necessary, we don’t know the optimal settings for many of their components, so there is a real need for quality assurance processes to continually improve these systems to minimize kidney disease complications.”

In her talk at WCN’22, Professor Jardine will explore new advances in trial design and the challenges of trial implementation and delivery of care. She explains: “We are currently in a really exciting time for nephrology trials. There is increasing exploration of new designs fed in part by technology advances and the emergence of new potential therapies.”

However, Professor Jardine will also argue that the generation of knowledge is not sufficient to change practice: “There is a science to implementation, and nephrology is in a good position to expand this science given the advent of new interventions. Kidney disease care is often delivered through complex health systems, which means optimizing learning health systems has the potential to to generate evidence and seamlessly implement it into care.”

Professor Jardine believes there will always be room to improve the science and delivery of trials: “We are not doing this on our own – multiple areas of medicine are grappling with how to best generate evidence in efficient ways that maximize learnings. The nephrology community is in a good position to progress trial and implementation science and has much to gain from doing so.”

Meg Jardine: “Implementation Science and Disseminating Research Findings (Partnership with ISN Research WG)”, Session “New Clinical Trial Designs in Nephrology”, Friday 25 February, 18:00-19:30 hrs Kuala Lumpur (Malaysia) time: https://cm.theisn.org/cmPortal/searchable/WCN2022/config/normal#!sessiondetails/0000015360_0