A new covariate randomization method for multi-arm randomized controlled trials

Lead Investigator: Yang Li, Renmin University of China
Title of Proposal Research: A new covariate randomization method for multi-arm randomized controlled trials
Vivli Data Request: 7782
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Covariates are independent variables that can influence the outcome of a given statistical trial. In causal inference and clinical studies, balancing important covariates is often one of the most important concerns. However, covariates imbalance still exist in many randomized experiments. This phenomenon of covariate imbalance becomes much more serious as the number of covariates p increases. If a significant imbalance exists, any inferences regarding the treatment effect will be inaccurate, and any claims about the treatment effect will need to rely on unverifiable assumptions .

To address this issue, we introduce a new randomization procedure. The proposed method allocates the units sequentially and adaptively, using information on the current level of imbalance and the incoming unit’s covariate. With a large number of covariates or a large number of units, the proposed method shows substantial advantages over the traditional methods in terms of the covariate balance, estimation accuracy, and computational time, making it an ideal technique in the era of big data. Also the proposed method is widely applicable in both causal inference and clinical trials.

Requested Studies:

A 24-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Compare Umeclidinium/Vilanterol, Umeclidinium, and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Data Contributor: GlaxoSmithKline
Study ID: NCT03034915
Sponsor ID: 201749

A Phase III, Randomized, Double-blind, Active Controlled, Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination FF/UMEC/VI With the Fixed Dose Dual Combination of FF/VI, Administered Once-daily Via a Dry Powder Inhaler in Subjects With Inadequately Controlled Asthma
Data Contributor: GlaxoSmithKline
Study ID: NCT02924688
Sponsor ID: 205715

A Randomized, Double-blind, Double-dummy, Parallel Group, Multicenter Study of Once Daily Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, Twice Daily Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Twice Daily Fluticasone Propionate 250 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents Already Adequately Controlled on Twice-daily Inhaled Corticosteroid and Long-acting beta2 Agonist
Data Contributor: GlaxoSmithKline
Study ID: NCT02301975
Sponsor ID: 201378