Division of Clinical Research and Training

Division of Clinical Research and Training and Department of Pharmacology

Introduction:

The 3rd One-week course on Randomized Controlled Trials (RCTs) was conducted as part of Diamond Jubilee celebration of St. John’s Medical College, Bangalore. It was conducted by the Division of Clinical Research and Training, St. John’s Medical College & Research Institute, in collaboration with McMaster University, Canada and Duke University from September 4^th to 8^th, 2023.

Six CME credits were awarded to eligible participants by Karnataka Medical Council.

Objectives of the course:

To provide participants a comprehensive understanding of the various aspects of designing, conducting and managing different types of RCTs.

Participants:

The course has been designed for faculty, postgraduate and PhD students from medical, dental, nursing and pharmacy colleges, ethics committee members, regulators, librarians and health policy makers. It may also be of interest to anyone looking to learn more about randomized controlled trials. We had 60 participants from 21 cities across India.

Faculty:

The faculty were from St. John’s Medical College, St. John’s Research Institute, Bangalore, McMaster University, Canada, Duke University USA and Thrombosis Research Institute, UK.

Course methods:

We had 20 interactive lectures, 4 small group protocol discussions, 4 journal clubs and 4 project presentations. There were 10 lectures on various RCT designs and methods, 7 on statistics, 2 on project management and 1 on Ethics.

The group activities included four journal clubs (Cluster RCT, Factorial Design, Non-inferiority and Adaptive Trials) and four project presentations (Cluster RCT, Factorial Design, Non-inferiority and Large Simple Trials)

The Zen protocol sessions were conducted with discussions between the group members and the faculty on the research question, design, methods, data analysis & budget. The projects developed during the sessions were presented at the end of the course.

The speakers for journal clubs and project presentations were picked up randomly by chits. After the presentations, the entire group answered questions from the audience and faculty.

Awards to participants

There were 2 categories of awards for the participants

1. Dr. Peter Sleight Award was given to the top 3 participants
2. Dr. Salim Yusuf Team Awards was given to best group for their performance

Feedback:

• Participants rated our course 4.4 out of 5 for fulfilling the objectives.
• Overall participants liked the choice of topics, excellent speakers, time management, group activities, attitude fostering team building and collaboration.