Clinical trials are a cornerstone of evidence-based practice in health. This five-day short course provides an introduction to study design, management, analyses and reporting of clinical trials. Participants are introduced to key concepts and requirements for ethical conduct and Good Clinical Practice (GCP) with a focus on international health trials. The course focuses on public sector and investigator-initiated research rather than pharmaceutical industry research. Participants will develop their own research protocol and will gain some hands-on experience in conducting clinical research. This program is designed to cover the fundamentals of methods for clinical trials (including trial design, randomisation, blinding, sample size etc.), ethical conduct and GCP, design of data collection tools and data management, introduction to data analysis and reporting of clinical trials.

Topics to be covered

Day 1: Introduction to key concepts in clinical research and GCP
Day 2: Clinical trial design
Day 3: Clinical trial management, data collection tools and data management
Day 4: Data analyses for clinical trials
Day 5: Clinical trial reporting

The course coordinator

The course will be coordinated by Dr Kamala Ley-Thriemer. 

Kamala has extensive experience in clinical trial design, management and analyses, and has conducted large-scale trials aiming to improve therapeutic options for a range of infectious diseases both in Africa and Asia. 

Kamala is the clinical trials coordinator at Menzies School of Health Research. She has lived and worked in the field in Asia and throughout Africa for many years, focusing on malaria, typhoid and cholera. 

She has expertise in vaccine trials, therapeutic trials and epidemiological studies. 

Kamala’s current research is focused on malaria studies, including a radical cure for vivax malaria and improving in-country capacity for malaria control.

Cost

AUD $2,000.00

Other information

Morning tea, lunch, refreshments and all study materials included. Participants will receive a certificate of attendance which can be used to apply for professional development points.