Unit 2 Summary

During week 2, you have learned about the necessity of statistics in Randomised Controlled Trials (RCTs).

In order to get the most from our trial and get informative results that can improve clinical practice, we need to ensure that we recruit sufficient people into the trial by first performing a sample size calculation. Whilst there is no expectation that you can now perform your own calculations (this should always be done by a qualified statistician), you should be familiar with the information that a statistician needs to calculate the required sample size and the consequences of recruiting too few participants.

You should also now be able to describe what a confidence interval is and describe why it is so important to report with the results of a trial. Confidence intervals account for sampling variation (the fact that different samples of the same size from the same population will not produce identical results), generating a range of plausible values that the treatment effect may take that are compatible with the data observed in the trial. You do not need to be able to calculate your own confidence intervals but you should now be better equipped to interpret such intervals.

You have also been introduced to the idea of a P-value and you should be able to interpret such values in terms of how much evidence they provide of whether the new treatment is superior to the current standard treatment or not. But remember that the P-value should always be reported alongside the confidence interval so that we can fully consider the clinical significance of the trial results, not just the statistical significance.

During the week you have also explored some of the preparation that is required to get a trial started, such as registration of the trial on a public database. You should be able to identify some of the roles and responsibilities of the variety of experts involved in the planning, delivery and management of randomised controlled trials. You should also be able to discuss the importance of involving patients and the public in the design of the trial (PPI).

You should be able to list the trial documents and plans that need to be created to ensure the efficient and effective delivery of the trial, the credibility of the data and processes employed in the management of risk. The process of research ethics and regulatory approval that must be sought and obtained before a trial can open, should also be familiar to you. Finally, you have learned about the importance of selecting clinical sites from which trial participants will be recruited and you should recognise the necessary features of an appropriate site such as the requisite numbers of the specific patient population, and staff resource and experience.

During week 3, we will explore the delivery of an RCT - how participants are recruited into trials and the importance of informed consent (one of the founding principles of research ethics and a central component of good clinical practice (GCP). You will gain an appreciation of the types of oversight and data management practices that are implemented to ensure confidence in the quality and credibility of the data and in the safety of the trial participants.

Finally you will explore the key issues in the statistical analyses and interpretation of a trial and will be introduced to some examples of how trial results are used to inform guidelines for clinical practice. We hope you continue to enjoy the journey through the lifecycle of the randomised controlled trial.

For Canvas related technical support please see the 24/7. The 'Help' icon on the left-hand navigation