Clinical Trials Workshop
Clinical Trials
The Mycetoma Research Centre
University of Khartoum
WHO Collaborating Centre on Mycetoma
The Mycetoma Research and Development Arcade
Clinical Trials Workshop
Workshop Overview
Clinical experimental research is necessary to establish the safety and effectiveness of specific health and medical products and practices. Much of what is known today about the safety and efficacy of specific products and treatments have come from randomised controlled clinical trials designed to answer important scientific and health care questions. Randomised controlled trials form the foundation for “evidence-based medicine”, but such research can be relied upon only if it is conducted according to principles and standards collectively referred to as “Good Clinical Research Practice” (GCP).
This workshop will provide a unique opportunity by giving an overview of this process and type of research study and introduce new and valuable knowledge for researchers in the field. Pioneering researchers and scientists in the field of clinical trials and research will facilitate this workshop and share their knowledge and experience.
Workshop Facilitators
A group of experts with track records in the design, conduct and analysis of trials in a variety of clinical specialities will facilitate the workshop, and among them:
- Prof Rod Hay, Sudan
- Prof Ahmed Hassan Fahal, Sudan
- Prof Ahmed Modawi Musa, Sudan
- Dr Monique Wasunna, Kenya
- Dr Sahar Mubarkh Bakhiet, Sudan, Sudan
- Dr Borna Nyaoke, Kenya
- Dr Reem Abdulaziz Abdulrahman, Sudan
- Dr Eiman Sadig, Sudan
Learning Objectives
By the end of the course, participants will have a good understanding of:
- What is a clinical trial
- Research Design and Experimental Methodology
- Clinical Trial Execution
- Good Clinical Practice of clinical trials
- Good Laboratory Practice of clinical trials
- Ethics in Clinical Research
- Independent ethics committee/ Independent review board
- Study protocol and compliance
- Patients Recruitment
- Roles and responsibilities
- Logistics
- Good Finance Practice (GFP)
- Quality systems
- Records keeping
Workshop Programme
| Date | Session |
| Saturday | |
| 9:00-11:00 | Ice-breaking
Setting workshop objectives Clinical trials introduction |
| Tea & Coffee | |
| 11:30-13:00 | Design of RCT:
randomisation, blinding, trial size |
| Lunch | |
| 13:30-15:00 | Alternative designs for clinical trials |
| Date | |
| Sunday | |
| 9:00-11:00 | Certified Good Clinical Practice |
| Tea & Coffe | |
| 11:30-13:00 | Importance of Ethics in Clinical Research
Participant consent, Data monitoring and when to stop early |
| Lunch | |
| 13:30-15:00 | The roles of Regulatory Affairs in clinical trials |
| Date | |
| Monday | |
| 9:00-11:00 | Certified Good Clinical Laboratory Practice
Introduction to GCLP Organisation & Personnel |
| Tea & Coffee | |
| 11:30-13:00 | Facilities, Equipment, Materials & Reagents
Standard Operating Procedures & Analytical Plan |
| Lunch | |
| 13:30-15:00 | Quality Management
Sample Management Data Recording and Reporting |
| Date | |
| Tuesday | |
| 9:00-11:00 | Introduction to statistical methods for both design and analysis Principles of design of experiments (randomisation)
|
| Tea & Coffee | |
| 11:30-13:00 | Power and sample size |
| Lunch | |
| 13:30-15:00 | Bias reduction (blinding) |
| Date | |
| Wednesday | |
| 9:00-11:00 | Developing a trial protocol |
| Tea & Coffee | |
| 11:30-13:00 | Reporting: how to write, and critique, a clinical trial report |
| Lunch | |
| 13:30-15:00 | Group Work |
| Date | |
| Thursday | |
| 9:00-11:00 | Clinical trials in practice
key steps in the logistical and practical implementation of a clinical trial patients recruitment |
| Tea & Coffee | |
| 11:30-13:00 | Trial governance and approvals
Monitoring and Auditing |
| Lunch | |
| 13:30-15:00 | Data processing
Data management |
| Date | |
| Saturday | |
| 9:00-11:00 | Good Finance Practice GFP
The key features of the Good Financial Practice |
| Tea & Coffe | |
| 11:30-13:00 | Financial management and internal controls
Procurement Governance |
| Lunch | |
| 13:30-15:00 | Feedback – Certificates
Closing ceremony |
Instruction Methods
This workshop is a hands-on training activity with various interactive instructional techniques. There will be brief presentations, with many small group teaching, discussions and presentations. It will include many online sessions with international experts in the field. A 30-minute optional drop-in session at the end of each day where students can ask any remaining questions one-on-one with tutors will be organised. There will be many homework assignments and groups presentations. Case studies and Sharing experience session will be included in the workshop.
Who Should Attend
The target attendees are all medical and health professionals, clinical research professionals, research managers, and other scientists who share an interest in the field of clinical trials and experimental research.
Workshop Duration
It is a six-day intensive workshop tackling different domains in clinical trials conduction and procedures.
Workshop Coordinator
Dr Eiman Saddig will coordinate the workshop
How will the assessment be done
- Pre-workshop MCQs to assess the basic knowledge of participants prior to the sessions
- Interactive sessions
- Post-workshop MCQs to assess the acquired knowledge and certificate will be handed after achieving the minimum pass score. Those who fail to achieve this score will be offered a second attempt to take the following workshop’s post-workshop assessment.
Workshop Evaluation
Oral and written participants and workshop facilitators feedback will be obtained