How can trials and real-world evidence provide the best possible evidence on the benefits and risks of implantable devices?

PROJECT OVERVIEW

Medical devices and surgical innovation have been under-researched in the past, leading to safety concerns and numerous high-profile scandals, such as those related to metal-on-metal hip replacements and surgical mesh. There is increasing recognition and regulatory need to rigorously evaluate the effects of implantable (high risk) devices.

Observational studies based on routinely collected health data (also known as real world evidence or RWE) and randomised controlled trials (RCT) are complementary sources of information that could be used together to answer different questions in the evaluation of implantable devices. It is therefore crucial that both types of studies are designed and conducted to complement each other to provide the best possible picture of the risk-benefit of any possible health technology or surgical innovation [1].

NDORMS has unique expertise in pragmatic surgical RCTs [2] and the use of large observational data to study the effects of medicines and medical devices. Recent collaborative work by the proposed supervisors has demonstrated how bridging the gap between these two fields will produce more efficient, comprehensive, and reliable information on the effectiveness and safety of implantable devices [3].

Through this 3-year studentship, we aim to investigate how RWE and surgical trials can complement each other, by researching:

1. How can RWE be used to inform the feasibility of recruiting for upcoming surgical trials?
2. How do surgical RCT participants (patients and surgeons) compare to patients undergoing similar procedures across the wider NHS?
3. When and how can observational RWE replicate the findings from RCTs?

TRAINING OPPORTUNITIES

Alongside departmental training opportunities listed below we will ensure hands-on training in real world data analysis using medical records and genetic data from the Pharmaco- and Device epidemiology research group and on surgical trial methods by attending the Bristol Oxford Surgical Trials Intevention Course (BOSTiC) course. Our interdisciplinary research groups contain a variety of students and post-doctoral researchers with expertise in health data science, epidemiology, and clinical trial methods. The student will work on their unique project within an experienced and collaborative supervisory team.

A core curriculum of lectures will be taken to provide a solid foundation in a broad range of subjects including statistics, epidemiology, and big data analysis. All students will attend a 2-day Statistical and Experimental Design course at NDORMS, and our residential 5-day Real World Evidence Summer School. Students will also attend regular seminars within the department and have access to a variety of other courses run by the Medical Sciences Division Skills Training Team https://www.medsci.ox.ac.uk/study/skillstraining and the wider University.

Finally, the student(s) will regularly present data in departmental seminars, Pharmco- and device epidemiology group lab meetings, Wolfson Trauma Cluster meetings, International Society of Pharmacoepidemiology meetings, and at the IDEAL Conference.

KEY PUBLICATIONS

1)    Wang SV, Schneeweiss S, et al. Emulation of Randomized Clinical Trials With Nonrandomized Database Analyses: Results of 32 Clinical Trials. JAMA. 2023;329(16):1376-1385. doi:10.1001/jama.2023.4221

2)    Miguel A Fernandez, Juul Achten, Nicholas Parsons, Xavier Griffin, May-Ee Png, Jenny Gould, Alwin McGibbon, and Matthew Costa.. Cemented or Uncemented Hemiarthroplasty for Intracapsular Hip Fracture. N Engl J Med 2022; 386:521-530
DOI: 10.1056/NEJMoa2108337

3)    Prats-Uribe A, Kolovos S, …, Beard DJ, … and Prieto-Alhambra D. Unicompartmental compared with total knee replacement for patients with multimorbidities: a cohort study using propensity score stratification and inverse probability weighting. Health Technology Assessment Volume: 25, Issue: 66, Published in November 2021 https://doi.org/10.3310/hta25660

4)    Guidance: Regulating Medical Devices in the UK. https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk 

KEYWORDS 

Real world evidence, surgical trials, implantable devices, epidemiology, data sciences

HOW TO APPLY

It is recommended that, in the first instance, you contact the relevant supervisor(s) and the Graduate Studies Office (graduate.studies@ndorms.ox.ac.uk) 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 in a relevant subject and will need to provide evidence of English language competence (where applicable).

The application guide and form is found online and the DPhil will commence in October 2024.

Applications should be made to one of the following programmes using the specified course code:

-       DPhil in Clinical Epidemiology and Medical Statistics (course code: RD_NNRA1)

For further information, please visit http://www.ox.ac.uk/admissions/graduate/applying-to-oxford.