Key facts

Sorry, this course was heavily oversubscribed and cannot take any more students into this class. Please use the course enquiry form to be kept informed of future runs of this course or to join the waiting list.

Overview

This module will take the participants through the process of undertaking a randomized trial. It will focus on the practicalities of organising and running trials rather than the theory, which will have been taught in the introductory modules, and will draw on earlier teaching on, for example, ethics and statistics. It will discuss the practicalities from the perspective of potential principal investigators and, so, will include processes for resourcing the trial, recruiting and randomizing participants, maintaining the trial's momentum, and analysing and reporting it.

Description

As well as being relevant to people who will conduct randomized trials, this module has been designed to help people who will use knowledge from randomized trials done by others, since it will provide them with a thorough understanding of decisions that will have been taken during a trial and how this might influence its quality and relevance.

The Randomized Controlled Trials and the Systematic Reviews modules are both led by Mike Clarke who is Cancer Research UK Staff Scientist at the Clinical Trial Service Unit at the University of Oxford, Director of the UK Cochrane Centre in Oxford, and Adjunct Professor at the School of Nursing and Midwifery, Trinity College, Dublin.

"The participation was key to enjoying the course. Everyone was happy to present and contribute. The teaching style was relaxed, facilitative, and very knowledgeable of the subject area."

"A really practical course, very enjoyable, demystifying and well taught. Very useful to have reference material for the course. Feel well equipped to carry out assignment."

Who is it for?

This course focuses on the practice, more than the theory, of randomized trials. It tackles practical issues that are often encountered in such research.

The course will be of most benefit to someone planning to do a trial in the near future; but should also be useful to anyone who may do a trial or wants to find out more about how to interpret trials done by others.

Some knowledge about evidence-based healthcare, randomized trials and systematic reviews would be helpful, but is by no means essential.

Dates

Randomized Controlled Trials is a five-day course that takes place on non-consecutive days, next dates to be confirmed. The days are non-consecutive because at this level of teaching participants need time to assimilate each day's course work and to prepare for the subsequent session.

Each day's programme will be from 9:30 to 17:00 with breaks for lunch and refreshments.

Participants will receive the full course syllabus, which includes introductory reading materials and exercises, before the start of the course in order to do any preparation needed.

Programme details

The course will follow a problem-based learning approach.

In the first session, each participant will be asked to identify the question for the particular randomized trial that they would like to discuss during the course. Each participant will also be asked to highlight any particular challenges anticipated with this trial.

The issues to be tackled in most detail in the other nine sessions will be determined through discussion within the small group. There are no plans for formal lectures, but suitably experienced tutors will be identified and invited to participate in sessions if the need arises.

The course will cover the following topics:

• Identifying the question for your randomized trial
• Patient selection and obtaining informed consent
• Data collection
• Randomizing patients
• Outcomes and statistical analysis
• Management of a trial
• Maintenance of a trial
• Reporting and dissemination of the trial results
• Costing and grant applications
• Where to get help in the future

Course aims

Benefits

By the end of this module students will be able to:

• specify a clear question for a randomized trial
• specify the inclusion and exclusion criteria for the participants in a trial
• prepare and submit an entry for the trial in an appropriate register
• identify appropriate strategies for recruiting patients, including information leaflets and obtaining consent
• prepare a clear timeline for the study, relating to both the passage of an individual patient through the trial and also to the study as a whole
• determine what resources, both financial and personal, are needed for a trial
• determine and implement an appropriate method of randomization for a trial
• prepare a statistical analysis plan for a randomized trial
• plan and implement strategies to maintain or increase recruitment to a randomized trial
• prepare a high quality report of the findings of a randomized trial
• use this knowledge to assess the quality and relevance of randomized trials done by others

Assessment methods

Accommodation

Accommodation is available at the Rewley House Residential Centre, within the Department for Continuing Education, in central Oxford. The comfortable, en-suite, study-bedrooms are rated 3-star, and come with free high-speed internet access and TV. Guests can take advantage of the excellent dining facilities and common room bar, where they may relax and network with others on the programme.

Scholarships

Details of funding opportunities, including grants, bursaries, loans, scholarships and benefit information are available on our financial assistance page.

Fee options

Programme Fee

For students enrolled on the MSc in Evidence-Based Health Care: £1450.00

Stand-alone short course: £1790.00

Apply for this course

Programmes including this module

This module can be studied as part of these programmes:

• MSc in Evidence-Based Health Care
• MSc in Experimental Therapeutics
• Postgraduate Diploma in Health Research
• Short courses in health sciences