Brendon L. Neuen, Program Lead, Renal and Metabolic at The George Institute for Global Health, shared a recent article that He and His collogues co-authored in European Heart Journal, on LinkedIn, adding:
“This might be one of the most important perspectives we’ve written all year:
Randomized Trials in Cardio-Kidney-Metabolic Syndrome: Rethinking Late-Phase Drug Development for the 21st Century
With cardio-kidney-metabolic multimorbidity becoming the norm rather than the exception, and a growing pipeline of therapies that target systemic disease drivers (e.g. incretin-based therapies), the traditional ‘one-disease-at-a-time’ model of drug development is increasingly unsustainable. It is slow, inefficient, and risks leaving major therapeutic potential untapped.
We propose a conceptual framework for designing cardio-kidney-metabolic trials, exploring:
– The advantages and limitations of alternative trial designs
– Regulatory perspectives
– Implications for sponsors and other stakeholders
Newer approaches, such as a multi-trial programs in overlapping populations or using basket-like designs, could accelerate evidence generation and deliver benefits across cardiovascular, kidney, and metabolic conditions.
To fully realise the societal benefits of newer incretin-based therapies, trial design must evolve.
I have shared these ideas with several of you recently, but if you’re interested, I’m always happy to discuss.”
Title: Randomized trials in cardiovascular, kidney, and metabolic diseases: rethinking late-phase drug development
Authors: Brendon L Neuen, Hiddo J L Heerspink, Muthiah Vaduganathan
Read the full article in European Heart Journal.
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