Randomized Controlled Trials
Designing and improving your trial with the experts
This module will take students through the process of undertaking a randomized trial. It will focus on the practicalities of organising and running trials, and build on theory from the introductory modules. The module will use a problem-based learning approach in which each participant brings a specific topic for a trial to discuss, justify and revise during the module. Participants will consider the practicalities from the perspective of potential principal investigators, including the processes for resourcing the trial, recruiting and randomizing participants, maintaining the trial's momentum, and analysing and reporting it.
The last date for receipt of complete applications is 5pm Friday 27th October 2017. Regrettably, late applications cannot be accepted.
The overall aims of this module are to enable students 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
- Pocock, S. J. (1983). Clinical trials: a practical approach. Chichester, John Wiley
Comments from previous participants:
"Interactive sessions with lots of helpful and practical information for understanding and conducting a RCT."
This module is run over an eight week cycle where the first week is spent working on introductory activities using a Virtual Learning Environment, the second week is spent in Oxford for the face to face teaching week (this takes place on the dates advertised), you then have five weeks of personal study and you will be required to submit your assignment electronically the following week (usually on a Tuesday at 14:00 UK Local Time).
Accommodation is available at the Rewley House Residential Centre, within the Department for Continuing Education, in central Oxford. The comfortable, en-suite, study-bedrooms have been rated as 4-Star Campus accommodation under the Quality In Tourism scheme, and come with tea- and coffee-making facilities, free Wi-Fi access and Freeview 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.
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Short Course in Health Sciences: £2195.00
Students enrolled on MSc in Evidence-Based Health Care: £1795.00
Students enrolled on Postgraduate Cert in Health Research: £1795.00
Students enrolled on Postgraduate Dip in Health Research: £1795.00
Details of funding opportunities, including grants, bursaries, loans, scholarships and benefit information are available on our financial assistance page.
If you are an employee of the University of Oxford and have a valid University staff card you may be eligible to receive a 10% discount on the full stand-alone fee. To take advantage of this offer please submit a scan/photocopy of your staff card along with your application. Your card should be valid for a further six months after attending the course.
Professor Mike Clarke
Mike Clarke is Chair of Research Methodology and Director of the Northern Ireland Methodology Hub based at Queen’s University, Belfast. Mike was awarded a first class BA in Chemistry at the University of Oxford in 1984, followed by a DPhil on the history of suicide in England and Wales, with special emphasis on the use of poisons. He started work in health research in 1989 at the Clinical Trial Service Unit (CTSU) in Oxford, where he became responsible for collaborative overviews of cancer treatments. In these systematic reviews, individual participant data are collected and analysed for all patients entered into relevant trials. The largest of the projects concerns the treatment of operable breast cancer and has provided reliable estimates of the effects of a variety of treatments, which influence the care of women with breast cancer worldwide. In April 1999, Mike took up the post of Associate Director (Research) at the UK Cochrane Centre and was Director there from October 2002 to March 2011, before moving to Queen’s University Belfast.
Mike has considerable experience in the conduct of large multicentre randomised trials and systematic reviews. He has been actively involved with trials in pre-eclampsia, subarachnoid haemorrhage, maternity care, breast cancer and poisoning - each of which are among the largest ever randomised trials in these conditions. Mike has been involved with the University of Oxford’s MSc in Evidence Based Health Care since the course began, and developed the Randomised Trials and the Systematic Reviews elective modules. He continues to teach both these modules. He has established the SWAT and SWAR (Study Within A Trial / Review) programme to encourage the embedding of methodology research into prospective studies and reviews. He is also actively involved in promoting the use of research-based knowledge in disasters and humanitarian emergencies, through Evidence Aid.
Mike received the title Professor of Clinical Epidemiology from the University of Oxford in October 2004. He is also a Visiting Professor of the Evidence Based Medicine and Clinical Epidemiology Centre of the West China School of Medicine in Chengdu, home of the Chinese Cochrane Centre; Adjunct Professor in the Schools of Nursing and Midwifery at Trinity College Dublin and the National University of Ireland in Galway; Extraordinary Professor in Clinical Epidemiology at Stellenbosch University in South Africa and Honorary Professor in Biostatistics at the University of Liverpool. In the last 30 years, Mike has published more than 300 papers and book chapters.
Assessment will be based on submission of two written assignments which should each not exceed 1,500 words.
Those wishing to take the course for credit. The University of Oxford Department for Continuing Education offers Credit Accumulation and Transfer Scheme (CATS) points for the course. Participants attending at least 80% of the taught course and successfully completing assessed assignments are eligible to earn credit equivalent to 20 CATS-equivalent points which may be counted towards a postgraduate qualification.
- attendance at five full days of teaching by world renowned experts in evidence-based health care at the University of Oxford.
- access to a dedicated online virtual learning environment prior to and during the five taught days
- access to pre-course reading materials
Applicants registering as "Attendance Only" are not eligible to undertake the academic assignment offered to students on award-bearing programmes of study and will not have access to the University library resources, other than those provided by the Department for Continuing Education. Applicants cannot receive CAT (Credit Accumulation and Transfer Scheme) points or equivalence. Credit cannot be attributed retrospectively. CAT accreditation is required if you wish for the module to count towards a further qualification in the future.
A Certificate of Completion is issued at the end of the course.
Attendance Only" applicants who subsequently wish to register for academic credit and complete the assignment are required to submit additional information, which must be received 1 calendar month in advance of the module start date. Please contact us for more information.
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This course requires you to complete the application form and the additional information form below and submit alongside a copy of your CV. If you are applying to take this course for academic credit you will also need to complete section two of the reference form and forward it to your referee for completion. Please note that if you are not applying to take the course for academic credit then you do not need to submit a reference.
Please ensure you read the guidance notes before completing the application form, as any errors resulting from failure to do so may delay your application.
- Short Course Application Form and Guidance Notes
- Additional Information Form
- Reference Form
- Terms and Conditions
To apply for the course you should:
- be a graduate or have successfully completed a professional training course
- have professional work experience in the health service or a health-related field
- identify a work based problem for which you will be seeking evidence
- be able to combine intensive classroom learning with the application of the principles and practices of evidence-based health care within the work place
- have a good working knowledge of email, internet, word processing and Windows applications (for communications with course members, course team and administration)
- show evidence of the ability to commit time to study and an employer's commitment to make time available to study, complete course work and attend course and university events and modules.
Terms and conditions
Terms and conditions for applicants and students on this course
Sources of funding
Information on financial support