RCT Course 2015 - Student perspective


The Randomised Controlled Trials course run by the Centre for Statistics in Medicine took place from 21st to 25th September 2015 at Pembroke College.

The first two days focused on the design and conduct on randomised trials. The first day built a strong foundation looking at defining your research question, outcome measures, external validity, and different clinical trial designs. The second day was based on the practicalities of trial design and conduct with presentations on areas for potential bias in a trial (and how to avoid these), randomisation, basic statistical concepts, and the development of a trial protocol.

The third and fourth days focused on data analysis and monitoring and topics included sample size calculation, interim analysis, missing data, subgroup analysis, and practical issues in the conduct of trials, for example, problems with over-optimistic recruitment targets.
Throughout the course, there were small group sessions based on the key concepts discussed in the presentations. These sessions included exercises so that you were able to use the knowledge gained in practice and this really helped to reinforce the ideas presented earlier in the day and allowed you to discuss topics in more detail. The small group sessions also allowed you to interact with the other attendees and it was a great opportunity to engage with people from different backgrounds including clinicians and health professionals from different medical specialities (from nutrition to physiotherapy to surgery) and statisticians, as well as journal editors and research managers for funding bodies.

During each day of the course, part of the day was set aside for a design-a-trial practical session where attendees had to design a randomised controlled trial according to a brief. This was a very useful exercise to highlight the practical issues that can arise when designing a trial and discussing as a group how to overcome these issues. It also showed how the course progressed since you could feed in more information as you gained knowledge during the presentations.

On the final day, Doug Altman rounded off the course with a presentation on interpreting published trial reports and each group presented the trial they had designed during the design-a-trial practical sessions and the reasoning behind their design choices.

As a statistician, many of the statistical concepts such as sample size calculation, randomisation and data analysis issues were very familiar to me. I feel I gained from the course in the discussion of issues which arise in practice which you might not have previously considered, such as ensuring that your trial is designed such that it is externally valid, deciding whether to carry out a pilot study, and methods to improve patient recruitment and retention. In addition, it was helpful as a learning experience to see how others present statistical ideas to a general audience including researchers with mixed levels of statistical knowledge. It was also really interesting to discuss issues around randomised controlled trials with researchers from such a wide range of occupations and clinical areas and I think everyone was able to learn but also offer opinions and advice from their own experience.

The course was a great overview of the various aspects of randomised controlled trials with a focus on practical issues. The presenters were all engaging and clearly passionate about the area, especially in terms of promoting good practice in research. The course materials provided were clear and comprehensive and it will be really helpful to be able to refer back to them in future.