RCTs in CKD: A Warning Box!

Written by Meguid El Nahas on Thursday, 26 October 2017. Posted in OLA Blog

RCTs in CKD: A Warning Box!

The majority of RCTs in Nephrology are flawed and invalid for a range of reasons:

https://link.springer.com/content/pdf/bfm%3A978-3-319-10292-4%2F1.pdf

Having said that, Nephrology journals continue to publish such trials and mostly small, underpowered, Proof of Concept (POC) clinical trials without a WARNING SIGN!

Whist such trials often justify and stimulate future research, most readers without critical knowledge accept them as final proof of efficacy and go on applying their recommendations to their patients...

Small POC clinical trials (Phase2 trials) are hypothesis generating and not proof of efficacy. Thus they require confirmatory studies and larger RCTs to justify their conclusions.

Authors and their accomplice, the Journal Editors, not to mention the ill informed reviewers accept their conclusions and publish them as definite findings, thus misleading the unaware reader!

I encourage EDITORS to put a WARNING SIGN OR BOX....reminding such readers that this Clinical Trial is a POC and NOT A FINAL STUDY; it thus warrants caution and confirmatory studies.

Meguid El Nahas

Professor Meguid El Nahas PhD, FRCP

Chief Editor, OLA Director

Professor El Nahas was born in Cairo, Egypt and undertook his undergraduate medical education in...

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