Typically, industry-sponsored phase III randomised controlled trials (RCTs) are much more expensive to run than those sponsored by academic institutions. However, the pharmaceutical industry cannot carry out every trial in which their product may improve patients’ outcomes. 

Academically-sponsored RCTs can fill this gap at a lower cost, adding to the regulatory submission for a particular drug. 

Our work ensures that any easy steps towards regulatory submissions are made before the trial starts or soon thereafter, to improve efficiency. This has the potential to make the UK a more attractive place for industry, particularly in terms of trials in the academic sector

What have we done? 

Our work in this area includes: 

  • By reviewing experiences from trial teams that have engaged with industry, we extracted a list of recommendations for academic-led clinical trials which, in collaboration with an industry partner, will or may be used in a regulatory submission. We presented this work at the International Clinical Trials Methodology Conference in 2022. 
  • We ran a session at the Society for Clinical Trials 2023 conference on the role of academic-led trials in supporting regulatory submissions. 
  • We secured funding for a PhD studentship starting in October 2024 from the MRC-NIHR Trials Methodology Research Partnership on increasing the impact of non-industry drug clinical trials through experience with regulatory submission.