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

 

   

 Please rate each item from zero to five according to your satisfaction

Participants Feedback Form

 

 

 

How to Apply

To apply for the course, please complete the Online Application Form

 

CPD Credits

5 CPD credits

 

Instruction Language

English

 

Contact Us

Dr Eiman Siddig

Workshop Coordinator

e.mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

Workshop Dates

Three times per year

 

Teaching Materials

The following books are recommended as additional background reading:

  • Wang D, Bakhai A. Clinical Trials: A Practical Guide to Design, Analysis, and Reporting. ReMEDICA, London, 2007.
  • Evans I, Thornton H, Chalmers I. Testing Treatments: Better Research for Better Healthcare. The British Library 2006.
  • Flather M, Aston H, Stables R (eds). Handbook of Clinical Trials. ReMEDICA 2001.
  • Pocock SJ. Clinical Trials: A Practical Approach. Wiley, Chichester, 1983