Prediction of recruitment in randomised controlled trials

Reference Number: NDORMS 2018/7

Themes;
Clinical Trials
Research Quality

Large multicentre randomised controlled trials are regarded as the gold standard for evaluating the effects of healthcare interventions. Participants are recruited across a number of centres and are randomly assigned to treatment groups. Research funders require researchers to calculate how many participants they require to address a specific research question, how long they need to recruit participants into the trial and how many trial sites are needed in order to reach that target.

However, rates of participant recruitment are not always straightforward and can have an enormous impact on the planning, execution and funding of randomised trials. Recruitment is often slower and more difficult than expected with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. Failure to recruit sufficient numbers of participants, or extended delays in recruitment can have serious implications for the success or failure of the trial. It’s estimated that less than one third of publically funded trials recruit according to their original recruitment target, often resulting in requests for additional funding and/or time extensions and delaying the use of the results of the trial in clinical practice. Current methods for predicting recruitment in randomised trials are limited and have limited clinical applicability.

The aims of this project are to better understand what factors influence recruitment in large multicentre randomised controlled trials and whether the use of statistical prediction tools, at the planning stage of a trial, can provide more accurate and realistic estimates of participant recruitment.

Details of Research Group:
The DPhil will be jointly supervised by Associate Prof Sally Hopewell (https://www.ndorms.ox.ac.uk/team/sally-hopewell) and Prof Gary Collins (https://www.ndorms.ox.ac.uk/team/gary-collins), based at the Centre for Statistics in Medicine (CSM) and the Oxford Clinical Trials Research Unit (OCTRU), NDORMS, University of Oxford.

• Associate Prof Sally Hopewell’s research interests are focused on the design, conduct and transparent reporting of randomised trials and systematic reviews and has published extensively in this area. She is co-chief investigator on a large multicentre NIHR funded trial of exercise interventions for people with rotator cuff disorders.

• Prof Gary Collins’ research interests are focused on methodological aspects surrounding the development and validation of multivariable prediction models and has published extensively in this area. He has a particular research focus on the novel application of prediction models in clinical trials

Training:
The Centre for Statistics in Medicine (www.csm.ox.ac.uk/) and Oxford Clinical Trials Research Unit (www.octru.ox.ac.uk/) are located in the Botnar Research Centre. CSM has more than 20 years experience in medical statistics and clinical trials. OCTRU, part of the CSM, is a fully registered Clinical Trials Unit, involved in the design, conduct and report in both early and later phase clinical trials in surgery, musculoskeletal sciences, respiratory medicine, gastroenterology and oncology.

Training will be provided in relevant related research methodology, including evidence synthesis, handling and analysis of datasets, and statistical techniques. Attendance at formal training courses will be encouraged, and will include the one-week “Randomised Controlled Trials Course” run by CSM and courses in statistics as relevant.

In addition, courses from the Oxford Learning Institute and the Oxford University Computer Sciences on key skills for the completion of a successful DPhil thesis will be available. Additional on the job training opportunities will arise, and the supervisors will encourage the student to pursue such opportunities.

A core curriculum of lectures organized departmentally will be taken in the first term to provide a solid foundation in a broad range of subjects including epidemiology, health economics, and data analysis. Students will attend weekly seminars within the department and those relevant in the wider University. Students will be expected to present data regularly to the department, the research group and to attend external conferences to present their research globally.

Further information:
Please contact: Associate Prof Sally Hopewell ([Email Address Removed]).

How to apply:
The department accepts applications throughout the year but it is recommended that, in the first instance, you contact the relevant supervisor(s) or the Graduate Studies Officer ([Email Address Removed]) who will be able to advise you of the essential requirements.

Interested applicants should have or expect to obtain a first or upper second class BSc degree or equivalent, and will also need to provide evidence of English language competence. The University requires candidates to formally apply online and for their referees to submit online references via the online application system.

The application guide and form is found online and the DPhil or MSc by research will commence in October 2018.

When completing the online application, please read the University Guide: https://www.ox.ac.uk/admissions/graduate/applying-to-oxford/application-guide?wssl=1