ABSTRACT
Objectives: The industry is experiencing a shift from conventional clinical trials to de-centralised trials (DCTs) driven by unprecedented access to anonymised patient data, increases in computational power advancing analytical capability and accelerated by the COVID-19 pandemic. DCTs offer the opportunity to run patient-centric trials, reduce the duration and cost of clinical trials, and improve data quality. This research aims to explore the opportunities of DCTs in a post-COVID environment for accelerating patient access and driving innovation. Methods: A primary research programme was conducted with HTA and budget-holding stakeholders in the EU4, UK and USto explore perceptions of the acceptability of the methodology of DCTs compared to conventional clinical trials and the key opportunities and challenges associated with trials of this nature for communicating value within payer evaluations. Stakeholders provided insights on the extent to which the COVID-19 pandemic has increased the acceptability of DCTs in payer evaluations across key global markets. Results: Despite variability in the awareness of DCTs as a methodology for clinical development, this approach is generally well accepted by payers. Most payers agreed that the COVID-19 pandemic has changed the requirements for clinical trials, potentially increasing the acceptability of DCTs. This was seen to the greatest extent in the UK. Accelerating access, increasing engagement in trials, and an increased patient-centric approach were identified as the most important opportunities associated with DCTs. However, challenges with this methodology also exist, including reluctance from regulatory authorities, implications of lack of contact with clinicians, and lack of control over clinical trials. Conclusions: Although conventional clinical trials may remain the gold standard, HTA and budget-holding stakeholders across the EU, UK and US recognise the potential that DCTs have in clinical development and value demonstration for new medicines, particularly in a post-COVID-19 environment driven by remote working and regulatory response to the pandemic.