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Uplifting the standard of monitoring in clinical trials – developing evidence and tools

   Institute of Clinical Trials and Methodology (ICTM)

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  Prof M Sydes  No more applications being accepted  Competition Funded PhD Project (Students Worldwide)

About the Project

Background: Clinical trial monitoring is essential to protect the rights and well-being of clinical trial participants and for data and trial integrity. However, there has been little collaborative work on monitoring until recently. A number of tools and processes have been devised by each trials unit separately and not assessed or publicly disseminated. The Trial Monitoring Plan (title may vary) is the “protocol for monitoring” in a clinical trial. Metrics are numeric measurements, calculated from data held in a trial database, and used to assess sites’ performance, often by comparison to a threshold. These metrics help those monitoring to identify sites that need more input. Many academic trials units have been using metrics for a decade or more, yet little work is reported on the effectiveness of these metrics or their thresholds. This PhD will provided evidence for tools. The work will be UK‑focused due to monitoring details being dependent on the competent authority.

There will be 3 key parts to this PhD:

1.   Trial Monitoring Plan template developed via a Delphi process: Create quality tool for trial monitoring set-up & conduct composed by monitoring experts & ratified by the competent authority

The student will run a Delphi process with the registered CTU monitoring leads to reach a consensus on what should be in a Trial Monitoring Plan template. The MHRA will be asked to review the plan; they have engaged with other national monitoring projects. The template will be published with guidance notes. This will improve efficiency and resilience of trials and improve the overall standard of monitoring. The impact for monitoring is anticipated to be similar to that of SPIRIT for protocols and the Statistical Analysis Plan template for statistics.

2.   Dissemination & improvement of the Trial Monitoring Plan Template via a qualitative study: improve implementation

The student will actively disseminate the Trial Monitoring Plan template and run focused interviews to evaluate the experience of 8-10 CTUs who have used the template. The student will amend, as necessary, the template and its implementation based on the feedback.

3.   Using data: evidence the effectiveness of monitoring metrics and thresholds

The student will receive monitoring data on ≥1 trial from 5-10 CTUs (3 CTU’s have already agreed). The student will run a Study-Within-A-Trial (protocol submitted to “SWAT repository” in 2021) on the monitoring data from each trial to collect information on how metrics and thresholds behave across time. Monitoring actions (e.g. site visits) and protocol amendments will be investigated in these trials. This work will be novel worldwide.

Professor Matthew Sydes will be primary supervisor. He has many years of Trial Conduct Methodology research experience and is/has been primary supervisor for 3 students & secondary for others. Associate Professor Sharon Love will be the secondary supervisor and the key link. She is chair of TMRP Trial Conduct Data Quality and Monitoring, chair of UKCRC Task and Finish Monitoring Group, member of PSI/EFSPI/ASA-BIOP central statistical monitoring and QTL group, has set up 6 national monitoring projects, has published 3 1st author monitoring papers since Jan‑2020 and is currently secondary supervisor for 2 PhD students. Dr Yorke-Edwards researches monitoring and supervises 1 PhD student. Associate Professor Talia Isaacs is an experienced qualitative researcher with an interest in trial conduct issues such as monitoring. Talia is/has been the primary supervisor for 4 PhD students, and secondary for many others.

The PhD student will work with the UK-wide monitoring community. This should mainly be achievable via virtual meetings and email.

There is unlikely a direct role within this project, although PPI support of trial conduct methodology is appreciated ( and MRC CTU’s PPI panel will be available.

It would be a huge benefit for candidates to have worked in clinical trials for several years, preferably in a trial management, data management, hands-on statistician or monitoring capacity. 


You are applying for a PhD studentship from the MRC TMRP DTP. A list of potential projects and the application form is available online at:

Please complete the form fully. Incomplete forms will not be considered. CVs will not be accepted for this scheme.

Please apply giving details for your first choice project. You can provide details of up to two other TMRP DTP projects you may be interested in at section B of the application form.

Before making an application, applicants should contact the project primary supervisor to find out more about the project and to discuss their interests in the research.

The deadline for applications is 4pm (GMT) 18 February 2022. Late applications will not be considered.

Completed application forms must be returned to: [Email Address Removed]

Informal enquiries may be made to [Email Address Removed]

Funding Notes

Studentships are funded by the Medical Research Council (MRC) for 3 years. Funding will cover tuition fees at the UK rate only, a Research Training and Support Grant (RTSG) and stipend (stipend to include London Weighting where appropriate). We aim to support the most outstanding applicants from outside the UK and are able to offer a limited number of bursaries that will enable full studentships to be awarded to international applicants. These full studentships will only be awarded to exceptional quality candidates, due to the competitive nature of this scheme.
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