Workshop B | Redesigning CKD Trials Around an Evolving Standard of Care to Protect Trial Integrity, Reduce Patient Burden & Accelerate Development
11:30 am - Tuesday 16th March 2027
With SGLT2 inhibitors, GLP-1s, MRAs and disease-specific therapies increasingly shaping background treatment, CKD developers must design studies that remain relevant several years after initiation. This interactive workshop will examine evolving comparator arms, placebo ethics, background therapy requirements, recruitment challenges and alternative platform, basket and adaptive approaches. Attendees will work through how smaller, better-defined populations can be studied without sacrificing statistical power or regulatory robustness.
What attendees will gain: A practical framework for designing feasible, ethical CKD trials as therapeutic choice and standard of care continue to evolve.
Key questions:
- How should background therapy be defined when standard of care could change materially during a 2–4-year trial?
- When does placebo control become scientifically or ethically inappropriate?
- Could platform, basket or adaptive trials reduce control populations while maintaining evidentiary quality?
- How can natural history or external control data support increasingly small patient populations?
- How should industry, regulators, patients and investigators align before initiating the next generation of CKD trials?