Phase II RCT Statistical Support — Empagliflozin in Non-Diabetic CKD
End-to-end statistical deliverables for a 180-patient multicenter Phase II RCT across 5 sites in the UAE and Saudi Arabia. Covered full SAP authoring, CDISC-compliant ADaM datasets, randomization scheme, pre-planned interim analysis, and final regulatory-grade report.
Project highlights
Methods & Tools
A Phase II chronic-kidney-disease RCT required a regulator-grade Statistical Analysis Plan and a primary analysis robust to missing data across 5 sites. The longitudinal endpoint had to be modeled without bias from informative dropout.
We authored the SAP to ICH E9, implemented a mixed-model-for-repeated-measures primary analysis, and stress-tested every conclusion with pre-specified sensitivity analyses.
Authored the ICH E9(R1)-aligned Statistical Analysis Plan, defining estimands, the primary model, multiplicity control, and the missing-data strategy before database lock.
Fitted the primary MMRM (SAS PROC MIXED) on the longitudinal endpoint across 180 participants with covariate adjustment and an unstructured covariance, independently double-programmed in R (nlme).
Ran pre-specified sensitivity analyses (multiple imputation, tipping-point) and time-to-event models, and produced CDISC SDTM/ADaM datasets validated with Pinnacle 21.
Regulator-grade Statistical Analysis Plan with clearly defined estimands.
Primary MMRM results, sensitivity analyses, and a full TLF package.
Validated CDISC SDTM/ADaM datasets with double-programming QC.
Statistical Analysis Plan finalized and signed off before database lock.
Primary analysis independently double-programmed in SAS and R for agreement.
Robustness confirmed with pre-specified sensitivity and tipping-point analyses.
Datasets validated with Pinnacle 21 against CDISC standards.
We were running a Phase II trial on empagliflozin in non-diabetic kidney patients, and the statistics were honestly beyond our own team. They handled the randomisation and the analysis plan from the beginning, and when the reviewers asked difficult questions, the answers were already there in the report. This saved us a lot of time.
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