Clinicians work closely with other members of the trial team and usually keep direct contact with site investigators and are directly involved in pharmacovigilance and safety event reporting within their trials.
An additional role for clinicians at the MRC CTU at UCL would be promoting trials, developing strategies to ensure recruitment and retention of study participants and providing medical advice to site investigators according to the study protocol. The group includes senior clinical academics and Clinical Research Fellows who often are also registered for higher research degree (PhD or MD).
We have developed and maintain a number of innovative systems to meet the needs of our studies, including clinical data management, randomisation, trial site administration, drug supply management and image collection and retention.
The group includes analyst programmers, business analysts and data scientists, and across the team we have built up many years of experience of systems development within the clinical trials sector. We work closely with other trial and study team members to deliver validated computer systems for CRF data entry, data management, randomisation, extracted data for analysis, reporting for managing data quality, websites and other trial-specific requirements. We also develop and support systems that support CTU processes such as portfolio management and system training delivery.
Systematic reviews are also used to provide the rationale for, and inform the development of, CTU trials and methodological research projects, and to place them in the context of other relevant studies.
The Meta-analysis Group was established within the MRC Cancer Trials Office in Cambridge in 1988. The Group has expanded to enable it to work on a range of systematic reviews, individual participant data meta-analysis and methodological research projects and currently has 5 members of staff. This also allows the Group to provide training and support on systematic reviews and meta-analysis, both internally and externally.
Most of the Group’s ongoing and published systematic reviews and meta-analyses are in the cancer field (e.g. prostate, bladder, brain, gynaecological, lung and soft tissue cancer). However, since becoming part of the MRC Clinical Trials Unit in 1999, it has conducted these projects in other diseases and conditions. The Meta-analysis Group also provides the main link between the MRC Clinical Trials Unit and the Cochrane Collaboration. Professor Jayne Tierney is the Functional Group and Programme Lead.
The group consists of roughly 15 staff in various roles including Research Administrators, Personal Assistants, a Facilities Officer, a Scientific Communications Officer, an Executive Assistant and the Unit Manager. The group liaises with all workers across the Unit.
The group aims to ensure the Unit operates efficiently, as well as ensuring that both internal and external stakeholders alike, receive a high level of customer service with a solutions focus, to maximise our impact on better health for all.
A clinical trials statistician would typically be involved in all steps of the clinical trial process from developing the research idea into a trial design, performing the sample size calculations, helping design the case record forms and database systems as well as performing the analyses and interpreting and reporting the results.
A number of our statisticians also work on clinical trial methodology which involves developing new statistical methods for the design and analysis of trials. Sometimes this involves writing statistical software to enable others to use the new methods we develop and sometimes we write software for methods already developed by others.
The group consists of around 120 staff in various roles including trials assistants, data managers, trial managers, clinical project managers (CPM) and clinical operations managers (COM). All of these staff members work together and closely with other members of the study teams on all aspects of study conduct, across all research themes, from the strategic planning phase through to the reporting of trials. The group is led by Fleur Hudson.
The group aims to enable the development and implementation of standard and efficient processes across all studies the Unit undertakes and to provide support to the trial teams, helping to maintain adherence to regulations and research governance, and producing data of the highest quality whilst engaging in conduct methodology.