Fundamentals of Clinical Trials
The Aga Khan University Department of Continuing Professional Education is accredited by the Pakistan Medical & Dental Council (PMDC) and the American Association of Continuing Medical Education (AACME) to provide continuing medical education. The American Association of Continuing Medical Education (AACME) designates this live educational activity for a maximum of 25.00 AACME Category 1 Credit(s). Each participant should only claim those hours of credit that he/she actually spent in the educational activity.
Introduction
Clinical trials are experiments designed to evaluate new interventions for diagnosis, treatment and prevention. The interventions evaluated can be drugs, diagnostic tests, vaccines, devices etc. Results of randomized clinical trials are usually considered vital for determining the efficacy of an intervention.
Clinical Trials Unit (CTU) is a JCIA accredited state of the art facility, that provides services for all aspects of clinical trials including protocol reviews and approvals, operations, investigational product management and capacity building for the investigators and research team.
Goal
The aim of this short course is to teach basic principles of designing and running a randomized clinical trial. Good Clinical Practices (GCP) certificate will also be provided to the participants.
Outline
- Significance of randomized controlled trials - When and why
- Designing a trial: randomization and blinding
- Ethical consideration and good clinical practices
- Application of appropriate statistical methods in design and analysis of a trial
- Reporting of a clinical trial
- Critical appraisal of evidence based learning
Educational Strategies
The course follows a workshop approach facilitated through lectures and hands-on training.
Prerequisite
Some background knowledge of epidemiology and biostatistics.
Medium of Instruction
The medium of instruction for the course is English. Participants are expected to be proficient enough to comprehend, read and write in the English language.
Who Should Attend
- Faculty and Residents
- Professionals/academic health science educators involved in teaching
- NGO representatives with technical responsibilities for Conducting and Monitoring clinical trial
Duration
The five days (9:00 am-4:00 pm) course is scheduled to be offered from November 6-10, 2017, both days inclusive.
Tuition Fee
The tuition fee of course is Pak. Rs 20,000 (US$ 250 applicable for international participants). The tuition fee covers classroom instructions, course material, refreshments and simple lunch during working hours.
Course Director
Dr Shiyam Sunder
Course Instructors
- Dr Sarah Saleem, Professor, CHS, AKU
- Dr Sumera Ali, Senior Instructor, CHS, AKU
- Dr Saeed Hamid, Director, CTU
- Ms Dilshad Begum, Asst. Manager, CTU
Registration
Participants will be selected on the first-come first-serve basis. Kindly send a filled Registration Form to chs.cep@aku.edu / Ms Nadira Ashraf.
