The ISN Holds Consensus Meeting on Changing Paradigms of Studies in CKD
The ISN PARADIGM meeting took place in Vancouver, BC, Canada, from November 22-23, 2024.
The meeting gathered clinicians, trialists, patient partners, regulators, and industry scientists to rethink current concepts of laboratory values in chronic kidney disease (CKD) populations, the value of patient-reported outcomes, and trial designs while fostering a robust culture of clinical trials.
The program of work will be of benefit to all relevant stakeholders:
- Patients: improved tools and approaches to assess and treat changes in laboratory values that may or may not correlate with patient-reported outcome measures; renewed focus on patient-reported outcome measures
- Clinicians: improved understanding and renewed interest in understanding and approaching treatment strategies in CKD populations
- Researchers: renewed interest and excitement in novel trial designs and paradigms linking complex physiology with patient-oriented outcomes and drug mechanism of action
- Industry partners: improved trial design and more nuanced questions with an emphasis on specific populations. There may be improved appropriate use of their medication/s
- Regulators: improved understanding of the value of novel paradigms/treatment approaches. Molecules may inform regulatory requirements for existing and novel agents
Shared benefits include recognizing the importance of patient-reported outcomes in enhancing shared decision-making and shaping clinical practice and trial design.
Recommendations from the meeting will be developed in 2025.
The meeting was supported by several organizations (in alphabetical order): Alexion AstraZeneca Rare Disease, Amgen, Astra Zeneca, Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk, and Otsuka. Can-SOLVE CKD Network and Michael Smith Health Research BC, BC Support Unit supported the patient-partner participation.
