Replication of three clinical trial emulations CANVAS, LEADER, and SAVOR TIMI that form part of the RCT-Duplicate initiative, sponsored by the FDA and delivered by the Brigham and Women's Hospital and Harvard Medical School. AstraZeneca will use the Instant Health Data platform PANALGOS (IHD) for the analyses.

RCT-duplicate (RCT-D) is an initiative led by the Brigham and Women's Hospital and Harvard Medical School, that selected 30 clinical trials as part of an empirical experiment where these trials would be emulated using RWD. AstraZeneca will replicate three emulations CANVAS, LEADER, and SAVOR TIMI from among the 30 plus clinical trials analyzed in RCT-D. These clinical trials assess type 2 diabetes mellitus drugs. The replications will be conducted on the Instant Health Data PANALGOS (IHD) platform to assess these studies in two claims databases Optum and IBM Watson Market Scan. The aim is to recreate these three emulations to investigate the reproducibility of the emulations, increase transparency and better understand the process of trial emulations; and where possible, contribute with potential improvements to the RCT-D framework.

The Eligibility Criteria for CANVAS, LEADER and SAVOR-TIMI are replicated

Please see the Criteria for each under:

• CANVAS: https://clinicaltrials.gov/ct2/show/NCT03936010
• LEADER: https://clinicaltrials.gov/ct2/show/NCT03936049
• SAVOR-TIMI: https://clinicaltrials.gov/ct2/show/NCT03936023

Type 2 diabetes mellitus (T2DM) adult patients enrolled in the two claims databases and are eligible to be included according to the inclusion and exclusion criteria of each of the three investigated clinical trial studies: CANVAS, LEADER and SAVOR-TIMI.

All subjects meeting the inclusion and exclusion criteria will be assessed. Remaining sample size will be dependent on the number of matched subjects in each cohort using the two data sources combined.

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

from 05 December 2022

Protocol and SAP details along with programming code to be supplied upon request via mail.