Surgical trials are failing to use efficient statistical methods that could speed up the development of better operations and procedures. While drug trials routinely use early-phase designs, real-world evidence, and computer simulations to identify promising treatments quickly, surgical trials rarely adopt these tools. This means effective surgical interventions take longer to reach patients, and ineffective ones may waste resources before being dropped. The problem is compounded by the complexity of surgery—multiple interacting components such as technique, equipment, and aftercare—which standard trial designs handle poorly. This programme will develop a new statistical framework tailored to surgical trials. It will create an international network of statisticians, adapt early-phase methods from drug development, and apply behavioural-science designs that can test individual components of a surgical intervention. If successful, the framework could increase both the number and quality of surgical trials, giving patients earlier access to proven procedures and helping the NHS adopt only the most effective operations. The work is methodological—it does not test a specific surgery—but its impact would be felt across every surgical specialty, from orthopaedics to cardiac surgery.
View original technical description
Research question: What are the best statistical methods to improve the quality and quantity of clinical trials of surgical interventions? Background: Clinical trials are the gold standard research method for providing the evidence to change clinical practice but the number of trials of surgical interventions is low. There are efficient statistical designs used in the evaluation of drug treatments to identify active treatments early. These include single stage studies of real world evidence and emerging simulation methods used in engineering for device development. These statistical methods are rarely used in the evaluation of surgical interventions. Effective surgical interventions need to be assessed better and earlier in the research pathway to accelerate to late phase effectiveness trials more quickly. Surgical interventions are complex interventions made up of multiple interacting components. There are novel statistical designs used in behavioural sciences that statistically optimise interventions for late stage evaluation by investigating the component parts. Robust evidence of component parts ensures i) effective interventions are not dropped inappropriately ii) understanding of why interventions are ineffective. These statistical methods are rarely used in the evaluation of surgical interventions. This programme will develop and make recommendations for the statistical evaluation of complex surgical interventions through a new statistical framework. Aims: 1. To improve the health of patients by increasing the quality and quantity of clinical trials of surgical interventions 2. Develop and disseminate a new statistical framework for surgical trials research embedding early phase, novel and efficient designs not currently being used 3. To create an international statistical network dedicated to surgical trials research 4. To become an international leader in the statistical methodology for surgical trials research Objectives: 1. Create an international statistical network for surgical trials research 2. Streamline the research pathway using early phase methodologies and in silico computer simulated evidence 3. Use novel and efficient statistical designs to optimise interventions 4. Develop and make recommendations for the statistical evaluation of complex surgical interventions 5. Undertake a bespoke leadership development programme to develop my international leadership role Methods: WP1: International Statistical Network Bring together existing networks and collaborations to develop an international network of statisticians dedicated to the design and analysis of clinical trials of surgical interventions. WP2: Early Phase Research Identify and redesign early stage surgical trials adopting and adapting early phase methodologies, considering single stage designs of real world evidence, early phase randomised designs, simulation methods incorporating Bayesian designs. Identify potential barriers to uptake, make recommendations for adoption. WP3: Optimised Interventions Identify and redesign surgical trials using novel multiphase optimization strategy (MOST) and sequential multiple assignment randomised trial (SMART) designs to statistically screen for active components simulating design properties. Identify potential barriers to uptake, make recommendations for adoption. Timelines for delivery: I will compete the research and my development programme in 60 months. Anticipated impact and dissemination: Disseminate framework to methodologists, clinicians, public, funders, intervention developers, industry partners and commissioners; enhanced surgical trials portfolios with improved opportunities for patient participation and evidence for rollout of optimised surgical interventions.
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know