Advanced Clinical Trials
[ EL013 ]

The Randomized Controlled Clinical Trial (RCT) is the most reliable method of assessing the efficacy and effectiveness of interventions. In order to provide the best possible evidence-based health care, health professionals must be able to judge the scientific merits and clinical relevance of published RCTs. In addition, they may be involved in designing and performing a RCT and are frequently asked to recruit patients for RCTs.

Reports published in major medical journals show a surprising variability in methods including choice of study design, blinding, avoidance of bias, outcome measures, effect parameters, sample size calculations, data analysis techniques, presentation of results in tables and figures, and inferences made from the results. Hence, appraising trial reports can be challenging. In designing RCTs many difficult decisions need to be made with respect to these same issues.

In this course these topics and issues will be addressed and developed through lectures and group practical sessions. A laptop during classroom sessions is required in order to do the practical assignments.

• Be able to critically appraise and interpret intervention research

• Understand study design issues related to both pharmacological and non-pharmacological interventions

• Understand potential forms of bias in intervention research 

• Understand the key features of non-inferiority RCTs, factorial RCTs, cross-over RCTs, cluster RCTs, stepped wedge cluster RCTs, pre-randomization, preference trials, cohort multiple RCT, SMART designs, MAMSdesign, basket master protocols, umbrella master protocols, platform designs, and adaptive design

• Be able to design a study and understand the key elements of a study protocol

• Understand practical issues in performing a clinical trial

• Be able to analyse the data from a clinical trial and make justified inferences from the results

• Be able to synthesize data from published clinical trials 

Introductory courses in clinical epidemiology and medical statistics.

Assignment(s)

T.B.A.