Maeve P1, Reena M1* and Aanchal K2
1Department of Sleep Disorders, Cleveland Clinic Lerner College of Medicine, USA
2Department of Critical Care Medicine, Respiratory Institute, Cleveland Clinic, USA
In the realm of clinical research, the Randomized Controlled Trial (RCT) study design-which is most often characterized by random assignment of a participant to a treatment or control arm-has long been considered the gold standard to assess the impact of an intervention. The current review is structured to serve as a resource for the clinician to understand the salient aspects of the conduct and interpretation of clinical trials. Specifically, the following will be reviewed: 1) including an a priori hypotheses with clearly defined primary and as indicated secondary endpoints, 2) utilizing a design in accordance with standards Consolidated Standards of Reporting Trials (CONSORT) inclusive of a statistical approach, 3) considering ethical aspects such as clinical equipoise, 4) implementing standardized reporting of results with publication of both statistically significant and non-significant findings, 5) objective oversight of trial conduct and tracking of adverse events, 6) transparency of the reporting of conflict of interest and funding source and 7) registry of clinical trial approach and results during study initiation and conduct.
Maeve P, Reena M, Aanchal K. Key Considerations in the Conduct of Randomized Controlled Trials. Clin Respirat Med. 2020; 2(2): 1016.