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Field trial and intervention studies

Dr Saad Omer, Emory University, Atlanta, USA

Wednesday 4 – Friday 6 June 2014

Lecture Room 5, Bristo Square, The University of Edinburgh


Full delegate fee £350. Subsidised fee £220
(for further details of subsidised places please contact l.marshall@ed.ac.uk)

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Programme
  Wednesday Thursday Friday
8.30am – 9.15am Registration    
9.15am – 9.30am Course overview

Group discussion/exercises
(Trial Concept sheets prepared by the students)

Group discussion/exercises
(Time for preparing group presentations)

9.30am – 11.00am

Session 1
(Introduction to Field Trials)

11.00am – 11.30am Refreshment Break Refreshment Break Refreshment Break
11.30am – 1.00pm

Session 2
(Trial Designs & Planning a Field Trial)

Session 5
(Data Management)

Group discussion/exercises (Presentation and structured group discussion of trial outline prepared by the students)
   

Session 6
(Analysis of Field Trial Data)

1.00pm – 2.00pm Lunch/Networking Lunch/Networking Lunch/Networking
2.00pm – 3.30pm

Session 3
(Sample Size and Power)

Session 7
(Ethical and Regulatory Issues)
Session 8
(Adverse Event Monitoring and DSMB)
3.30pm – 4.00pm Refreshment Break Refreshment Break Refreshment Break
4.00pm – 5.30pm

Session 4
(Conducting a Field Trial)

Group
discussion/exercises (Time for preparing group presentations)

Session 9
(Disseminating Results and Influencing Practice and Policy)


Overview

Requirements: A basic knowledge of epidemiology.

This course will develop understanding of design, conduct, and analysis of field trials and intervention studies. The course will focus on methods relevant to community and facility based trials in resource poor settings. However, several skills covered in this course will also be applicable to field and clinical trials in developed countries.

Upon completion of their course work, the students will be able to

  • Design programs, policies and/or interventions intended to improve health services and health status of individuals, communities, and populations
  • Conduct research, including formulation of specific research aim, conducting a literature review and formulating a hypothesis and selecting appropriate methodologies related to the emphasis
  • Implement strategies to prevent and control infectious diseases

also

  1. Design a simple field trial
  2. Outline trial objectives and primary and secondary endpoints
  3. Compute sample size and estimate power
  4. Outline eligibility criteria
  5. Choose appropriate population
  6. Develop randomization and masking procedures
  7. Outline enrollment and follow up procedures
  8. Analyze trial data including data for interim analysis
  9. Design case report forms and outline a trial data management system
  10. Describe regulatory requirements for conducting trials
  11. Develop consent forms and informed consent procedures
  12. Develop a study oversight plan; including plan for a Data Safety Monitoring Board (DSMB)
  13. Write a report of study results per CONSORT guidelines

Tutor

Saad B Omer, MBBS MPH PhD
somer@emory.edu

Textbooks

Primary Text:
Field Trials of Health Interventions in Developing Countries: A Toolbox
–Peter Smith & Richard Morrow
Additional Reading:
Clinical Trials: A Practical Guide to Design, Analysis, and Reporting
–Duolao Wang & Ameet Bakhai

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