Essentials of Clinical Trials

Essentials of Clinical Trials

Course overview

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

Video lectures and live online Q&A and practical sessions will 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.

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 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.)
  • Guest lecture

In addition to the formal teaching sessions, we will run two optional drop-in sessions on Wednesday and Thursday afternoon. Participants will be able to discuss specific questions about their own research with a member of staff from the Medical Statistics Department or the Clinical Trials Unit. We will provide forms for you to submit your questions ahead of the drop-in sessions.

Teaching format

Teaching will take place through a blend of pre-recorded video lectures and live Q&A and practical sessions.

Video lectures on each topic will be available to watch from one week before, and until 3 weeks after, the course. Participants will be expected to have watched the video lecture before the related live Q&A and practical. All participants are asked to please watch the video for the first lecture before the course begins on 4 July.

Live online Q&A and practical sessions will run each day of the course. These live sessions will take place from approximately 9.00am to 3.00pm British Summer Time (BST) with comfort breaks. The live sessions will take place online using Zoom and therefore participants will need to have a reliable internet service and a PC or laptop with microphone and speakers.

A Guest Lecture will be given by an invited speaker.

Course materials

The course materials include lecture videos which will be available to watch for 5 weeks as described above. Lecture notes and slides and practical handouts will be available to download and keep. All materials required for the course will be provided in advance. Practical solutions will be provided at the end of each practical.

The following are recommended as optional additional background materials:

  • Evans I, Thornton H, Chalmers I and Glasziou PTesting Treatments: Better Research for Better Healthcare.  Pinter and Martin, 2011.
  • Friedman LM, Furberg CD, DeMets D, Reboussin DM, and Granger CB. Fundamentals of Clinical Trials. Springer, 2015
  • Pocock SJ. Clinical Trials: A Practical Approach. Wiley, 1983
Entry requirements

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, statisticians and other scientists with an interest in clinical trials.