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Embedding randomised trials within routine care


   Faculty of Health and Life Science

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  Prof Carrol Gamble  No more applications being accepted  Competition Funded PhD Project (Students Worldwide)

About the Project

Background to the project

Data collected about an individual’s health in medical records, registries and hospital activity statistics is becoming increasingly accessible to researchers in an electronic form. Progress in achieving connectivity, data linkage and security now offers the possibility of better use of this data for research purposes. The ability to identify potentially eligible participants and follow them up through the health system for outcome data is facilitating the embedding of randomised trials within routine clinical practice.

How can randomised trials become part of routine care and best utilise current clinical care pathways?’ was identified as the number one priority in a study amongst patients, carers and healthcare professionals of research priorities for how to improve the process of how people are recruited to clinical trials1.

Innovative data-enabled study designs can answer pressing knowledge gaps in research evidence. However, the extent to which such sources of data are now being employed in research to deliver efficient clinical trials, potentially at a wide scale, is unclear. A recent study2 found that around half of NIHR-funded trials ongoing in 2019 in a UK cohort planned to collect outcome data from routinely collected health data (RCHD) sources. However very few trial teams described any assessments of data quality from RCHDs in their protocol. In addition, the pandemic has increased awareness about the ability of embedding trials in routine care, provoking consequent developments in relation to e-consent, e-PRO data capture, etc.

What the studentship will encompass:

The student will gain an understanding of the area through an update of the earlier review of trial protocols2 to describe who is doing what, when and why. They will undertake a survey and/or structured interviews with (i) trialists, to understand the rationale for design choices, including those related to data sources; and (ii) data controllers, to understand interactions with trialists during the design phase from their perspectives.  

Various issues may emerge from this research, providing the student with options for further research depending on their interest and experience. These may include: understanding engagement with patient-reported outcome data collection, assessment of data quality, understanding and engagement of health professionals and patients, improving adherence to forthcoming SPIRIT-Routine guidelines, international perspectives.

Paula Williamson, Carrol Gamble and Matt Sydes have wide-ranging expertise in clinical trials, with experience in trials both using RCHD and not. Keith Bodger, Ian Sinha and Kevin Southern will bring clinical perspectives, and are each involved in ongoing studies using RCHD supplemented with PROMs.

Opportunities exist for placements at CPRD, NHSD, UK Inflammatory Bowel Disease Registry, and UK Cystic Fibrosis Registry, with these organisations providing letters of support.

Together with the student, we will recruit two patient research partners to advise.  

A working knowledge of clinical trials and a willingness to undertake qualitative interviews (with training as required), is required.                                        

HOW TO APPLY

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:

http://www.methodologyhubs.mrc.ac.uk/about/tmrp-doctoral-training-partnership/

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.

References

1 Healy P, Galvin S, Williamson PR, Treweek S, Whiting C, Maeso B, Bray C, Brocklehurst P, Clarke Moloney M, Douiri A, Gamble C, Gardner H, Mitchell D, Stewart D, Jordan J, O’Donnell M, Clarke M, Pavitt SH, Woodford Guegan E, Blatch-Jones A, Smith V, Reay H, Devane D (2018) Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - The PRioRiTy (Prioritising Recruitment in Randomised Trials) Study. Trials 19:147
2 McKay AJ, Jones AP, Gamble CL, Farmer AJ, Williamson PR. (2020) Use of routinely collected data in a UK cohort of publicly funded randomised clinical trials. F1000Research, 9:323 (https://f1000research.com/articles/9-323/v3)
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