Essentials of Clinical Trials

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Organisation
London School of Hygiene & Tropical Science
Location
London, United Kingdom
Start - End
22 Jun - 26 Jun
Study Options
N/A

This course gives attendees a clear understanding of the fundamental principles of Randomised Clinical Trials (RCTs).

Lectures and practical sessions cover the key issues in design, conduct, analysis and reporting, with a focus on major clinical trials that directly influence clinical practice. Topics are addressed with perspectives from both public sector research and the pharmaceutical industry.

Who should attend?

The course is relevant to anyone who'd like to get an understanding of the rigorous evaluation of interventions in health care, including clinical research professionals, research managers, and other scientists with an interest in clinical trials.

Course fee

The course fee for 2020 is £1,873.50. Fees cover participation in the course, course materials, plus lunch and tea/coffee each day. Fees do not cover travel costs or accommodation.

Accreditation

The course has been approved by the Federation of the Royal Colleges of Physicians of the United Kingdom for 30 category 1 (external) CPD credit(s).

Course objectives

Teaching

The course will be coordinated by Jennifer Nicholas, Tim Collier and members of the Department of Medical Statistics who have extensive experience in the design, conduct and analysis of trials in a variety of clinical specialities.

Course content

The topics to be covered will include:

  • Design of RCT: randomisation, blinding, trial size
  • Ethical conduct: participant consent, data monitoring and when to stop early
  • Certified Good Clinical Practice (GCP) training
  • Introduction to statistical methods for both design and analysis
  • Alternative designs for clinical trials
  • Reporting: how to write, and critique, a clinical trial report
  • Clinical trials in practice
  • Practical experience in development of a clinical trial protocol. (Participants will work in small groups to develop and present trial protocols.)

Sessions run from 9.30am to 5.00pm each day, finishing early on Friday.

For further information about the general structure of the week, please view the Clinical Trials programme.

Course materials

The course will include some lectures, but the main focus will be on participatory practical sessions. All materials required for the course are provided. 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 and Stables R (eds). Handbook of Clinical Trials. ReMEDICA 2001.
  • Pocock SJ. Clinical Trials: A Practical Approach. Wiley, Chichester, 1983

Assessment

There is no formal assessment. At the conclusion of the course, a certificate of attendance will be provided including confirmation of Good Clinical Practice (GCP) training.


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