DEBATE-statistical analysis plans for observational studies.

Bart HiemstraFrederik KeusJørn WetterslevChristian GluudIwan C C van der Horst

Published in: BMC medical research methodology (2019)

With only few amendments, the guidelines for SAP of a clinical trial can be applied to a SAP for an observational study. We suggest SAPs should be equally required for observational studies and clinical trials to increase their transparency and validity.

Keyphrases

clinical trial
phase ii
open label
double blind
clinical practice
study protocol
health insurance
phase iii
randomized controlled trial