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Methodologies for pragmatic and efficient assessment of benefits and harms: Application to the SOCRATES trial

期刊: CLINICAL TRIALS, 2020; 17 (6)

Background/Aims: Standard approaches to trial design and analyses can be inefficient and non-pragmatic. Failure to consider a range of outcomes impede......

Endpoints for randomized controlled clinical trials for COVID-19 treatments

期刊: CLINICAL TRIALS, 2020; 17 (5)

Background: Endpoint choice for randomized controlled trials of treatments for novel coronavirus-induced disease (COVID-19) is complex. Trials must st......

Conditional estimation and inference to address observed covariate imbalance in randomized clinical trials

期刊: CLINICAL TRIALS, 2019; 16 (2)

Background Baseline covariate imbalance (between treatment groups) is a common problem in randomized clinical trials which often raises questions abou......

JIF:2.26

Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program

期刊: CLINICAL TRIALS, 2019; 16 (3)

Background Different approaches to safety event collection influence the determination of liver toxicity within drug development programs. Herein, a d......

JIF:2.26

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