Innovative clinical trials
Researchers at The George Institute for Global Health, UK, led by Executive Director Professor Otavio Berwanger, are spearheading a programme of work to transform that way we deliver large-scale clinical trials.
This programme is borne out of a recognition of the limitations of the ‘traditional’ clinical trial model – and the health gains (social, environmental and economic) – to be had in investigating pragmatic, innovative and efficient approaches.
In both the so-called ‘traditional’ and innovative trial models, the gold standard of randomisation controls for both known and unknown confounding factors that could influence trials outcomes, and represents the optimal method to work out whether a healthcare intervention reduces the risk of patient-important outcomes and so inform clinical practice.
Where the two models differ is that the traditional approach requires participants be screened and recruited in a trial site by a team of investigators, and so demands both an intermediary (a research team) and physical location (research site). These requirements are potential contributors to the drawbacks of this traditional model, including elevated costs, low recruitment rates, long completion times, lack of diversity, excessive carbon footprints, and complex operational procedures.
Professor Berwanger and team believe that improving overall trial efficiency and participant experience constitutes an important unmet need; one which tracks with recent estimates that indicate that the decentralised clinical trials market will expand at a compound annual growth rate of 5.7% from 2022 to 2030.
The innovative clinical trial programme explores virtual or decentralised approaches to clinical trials. In essence, these meet patients where they are: participants take part in the trial from their homes, ensuring research can continue even when site visits cannot, so boosting participant comfort and convenience. Decentralisation also enables investigators and funders to include a larger population in the study, thus boosting recruitment, improving diversity (in terms of participant characteristics, as well as greater feasibility in lower resourced settings), engagement and connection, and can see many trial tasks become virtual, with digital health technologies permitting continuous, real-time data collection, and artificial intelligence offering opportunities to optimise trial protocols, as well as monitor and improve patient safety.
The team is investigating the potential of a range of decentralised randomised control trials, from those that are completely digital to hybrid ones (in which some procedures are virtual and others are conducted on-site). Alongside colleagues from Imperial College London’s Clinical Trials Unit, and from the School of Public Health in the Faculty of Medicine and from partners in other countries, the team is establishing itself as an international reference centre for innovative trial design, methods, analysis, operations and training.
Check back for updates from the programme.