Critical Appraisal of Clinical Trials

Understanding Clinical TrIals, Importance of Randomization, Blinding, and Reporting

What you'll learn
To understand clinical trial protocols, sampling methods, randomization, allocation and concealment, and participant follow-up
To fully understand the nuances of randomization, blinding, intention to treat, selection bias, contamination and cross over effects, and losses to follow-up
To understand the basic elements of appropriate statistical analysis if clinical trials, handling of multi endpoints, and issues around stopping trials early
To be introduced to new clinical trial designs, such as inferiority trails and adaptive designs
To be able to list key threats to the validity and applicability of a trial that claims that a health intervention makes people better

Requirements
No prior experience required

Description
This course is intended to help learners improve their ability to critically appraise and apply evidence about healthcare interventions derived from clinical trials appearing in the health sciences literature. The course will review all aspects of clinical trials including:1) The importance of protocols and changes in protocols before, during or after the trial is completed2) Various ways that participants will be recruited and enrolled in the trial, including enrichment and other adaptative design3) The importance of randomization and how to ensure randomization worked within a clinical trial4) The importance of allocation concealment during the randomization process5) The importance of blinding participants during the conduct of the trial including patients, investigators, analysts, and monitors. Will also discuss instances where blinding may be more or less important in the validity of the study6) Review high-level approaches to analyzing the data and common pitfalls made in the literature7) Discuss the impact that missing data and losses to follow-up have on the validity of trial results8) Review the concept of planned cross-over trials9) Review additional trial designs including non-inferiority trials and how to ensure a trial does not make a false claim that two interventions are similar when in fact they are not.In addition to the lectures on understanding and appraising clinical trials, two bonus lectures will be provided. The first is aimed at taking results from clinical trials and introducing the concept of how to apply results to individual patients. The second bonus lecture will introduce observational research, how it differs from randomized controlled trials, and common pitfalls in many observational research conducted in health.

Who this course is for
All levels