RWD Clinical Trials | Droice Labs

RWD Clinical Trials

Explore how RWD clinical trials leveraging approaches such as external control arms, hybrid controls, pragmatic elements, and covariate adjustment are reducing timelines, costs, and patient burdens.

Covariate Adjustment

Enhancing Longitudinal Clinical Trial Efficiency with Digital Twins and Prognostic Covariate-Adjusted Mixed Models for Repeated Measures (PROCOVA-MMRM)

Paper

ArXiv

Hybrid controls

Emulating Randomized Controlled Trials with Hybrid Control Arms in Oncology: A Case Study

Paper

CPT

ECA

A Comparison of 7 Oncology External Control Arm Case Studies: Critiques From Regulatory and Health Technology Assessment Agencies

Paper

ViH ISPOR

Registry RCTs

CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration

Paper

The BMJ

Covariate Adjustment

Super-covariates: Using predicted control group outcome as a covariate in randomized clinical trials

Paper

Hybrid controls

Dynamic use of historical controls in clinical trials for rare disease research: a re-evaluation of the MILES trial

Paper

SCT

ECA

External Controls to Study Treatment Effects in Rare Diseases: Challenges and Future Directions

Review Article

CPT

Registry RCTs

Defining key design elements of registry-based randomised controlled trials: a scoping review

Review Article

BMC