{"id":2414,"date":"2022-11-01T09:34:57","date_gmt":"2022-11-01T09:34:57","guid":{"rendered":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/?p=2414"},"modified":"2022-11-01T10:58:26","modified_gmt":"2022-11-01T10:58:26","slug":"improving-the-basics-why-do-we-do-clinical-trial-monitoring","status":"publish","type":"post","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/improving-the-basics-why-do-we-do-clinical-trial-monitoring\/","title":{"rendered":"Improving The Basics: Why Do We Do Clinical Trial Monitoring?"},"content":{"rendered":"

Whilst working from home over the last two years I have had the pleasure of being part of a topic group within the Trial Conduct Working Group of the Trial Methodology Research Partnership looking at Data Monitoring & Quality led by Sharon Love.\u00a0 One of the things this group has done is come together across virtual space from eight different trials units in the UK, one clinical department in London and the Trial Methodology Research Network in Ireland to ask ourselves what sounds like a very simple question: What is the purpose of clinical trial monitoring. We recognised that despite working with the same regulations and guidance, in application to our CTU processes and systems as well as to individual trials, we all interpreted it slightly differently.<\/p>\n

Why is variation a problem?<\/em><\/p>\n

Variation that is due to the particular needs or risks of a study is entirely warranted, but we discuss waste a lot in relation to clinical research and therefore we need to make sure that all the activities we undertake fulfil their purpose, add value to the quality of the study and minimise the burden on participants and health services.\u00a0 In the UK this latter has become even greater a priority given the pressures on the NHS left by COVID and the effort to deliver COVID research.\u00a0 In order to reduce \u2018bad\u2019 variation it is important we collectively understand why we do clinical trial monitoring and the best methods to undertake that.<\/p>\n

What did we do?<\/em><\/p>\n

We reviewed all guidance that the CTUs referred to in making decisions about planning monitoring, including the regulators in the UK, US and EU as well as UK national and international guidelines. Each was reviewed by multiple people and then brought together as a group.\u00a0 We distilled this into a set of principles which were then shared with a broader group to see if they made sense to others.<\/p>\n

What did we conclude?<\/em><\/p>\n

The five principles reasons for monitoring that we produced were:<\/p>\n