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

Bayesian Prognostic Covariate Adjustment With Additive Mixture Priors

Paper

ArXiv

Hybrid controls

A Simulation-Based Evaluation of Statistical Methods for Hybrid Real-World Control Arms in Clinical Trials

Paper

SIB

ECA

Single-arm oncology trials and the nature of external controls arms

Paper

JoCER

Registry RCTs

Pragmatic randomized controlled trials: strengthening the concept through a robust international collaborative network: PRIME-9—Pragmatic Research and Innovation through Multinational Experimentation

Paper

BMC

Covariate Adjustment

Covariate adjustment in Bayesian adaptive randomized controlled trials

Paper

SMMR

Hybrid controls

Comparative Study of Bayesian Information Borrowing Methods in Oncology Clinical Trials

Paper

JCO

ECA

A systematic review of real-world evidence (RWE) supportive of new drug and biologic license application approvals in rare diseases

Review Article

OJRD

Registry RCTs

Patient Registries: An Underused Resource for Medicines Evaluation : Operational proposals for increasing the use of patient registries in regulatory assessments

Review Article