Good governance in the era of clinical trial innovation

Randomised clinical trials (RCTs) are changing. Firstly, they are moving out of controlled clinical settings and into real world contexts (e.g. Trials@Home; Ascend Plus; RECOVERY). Secondly, their designs are exchanging fixed, pre-determined parameters for adaptive, flexible approaches (e.g. REMAP-CAP).  Thirdly, they are tasked with reducing inequalities, both in access to trial participation and in their value to society.   

These changes are facilitated by innovations such as electronic recruitment and participation, adaptive statistical designs, and ‘platforming’ to examine multiple, discrete questions, interventions and populations within the same protocol. Such innovations promise improved efficiency without sacrificing scientific or ethical standards. 

Significant ethical questions are raised both by these changes and their techno-scientific innovations. In particular, it is unclear how existing systems of ethical governance and regulation – whose arrangements and frameworks are largely based on the conventions of fixed, centralised RCTs – should respond to such changes.  

This DPhil project will address one or more of the following topic areas (or propose associated topics) relating to good governance in clinical trial innovation: 

• How are regulators, policy makers and ethics governance systems approaching changes and innovations in RCTs? What do the ethical issues associated with these changes and innovations mean for regulatory, policy and governance systems? How should they change and adapt? 

• How should we think about and govern patient autonomy and clinical researcher responsibility in electronic recruitment and participation contexts? 

• How should we describe and manage trade-offs between the ethics of efficient design and trial ‘feasibility’ in comparison with maximising scientific/social value?  

• How should trial-specific governance processes – Trial Steering Committees, Data Safety and Monitoring boards, interim ethics review –  support good governance consistently across the range of trial designs?  

• How should we govern clinical trials so as to support better inclusivity and diversity in research? 

• How might the ethical issues associated with good governance in clinical trial innovation be understood in the context of learning healthcare systems? 

This project involves conceptual or theoretical research in ethics/moral philosophy or bioethics, with the possibility of the use of empirical ethics methods. Candidates will build analytical and critical thinking skills through regular meetings with supervisors, and participation in research seminars and workshops.  

Candidates will also further develop and refine their research skills (e.g., identifying a research question, developing an argument), and receive support in publishing their research in peer-reviewed journals. They will also receive professional mentorship (e.g., networking, building research collaborations, grant writing) and opportunities for career development (e.g., presenting their work at conferences). 

Candidates with a degree in ethics/moral philosophy or bioethics are encouraged to apply. They will have an interest in applying their previous training to ethical issues surrounding the governance of research and in clinical trials regulation.