Revolutionising research with innovative clinical trials

On Clinical Trials Day, Prof Otavio Berwanger, Executive Director of The George Institute for Global Health and Chair in Clinical Trials at Imperial College London, shares how rethinking the design and delivery of clinical trials can benefit all involved in medical research

Large-scale and high-quality randomised controlled trials (RCTs) are considered the gold standard in clinical research. Study participants are randomly allocated to intervention or control groups and their outcomes are compared, minimising bias and providing reliable evidence about the efficacy and safety of treatments. Clinical trials have been vital to some of the biggest advances in modern medicine, but they are not without their drawbacks.

Conducting RCTs is an expensive, time-consuming, and complex process. They take several years to complete and cost millions of pounds. Participants are also required to travel to central trial sites for assessments, making patient recruitment and participation difficult.

In response to these challenges, we have formed the Innovative Clinical Trials Hub. The hub aims to support projects across The George Institute, Imperial and those led by external organisations, to design, deliver and analyse innovative, efficient, and impactful, large-scale, patient-centric trials. In this sense, we are very proud of our excellent partnership with the Imperial Clinical Trials Unit (ICTU) and we will definitely work together in delivering high-quality, innovative trials. Similarly, we see great opportunities for developing efficient trial models in other regions, including Australia (where we have a strong partnership with the University of New South Wales – UNSW) and India. I am also very excited to collaborate with the UKCRC Clinical Trial Units network in my capacity as the new Chair of the International Registration Review Committee.

Key to this is decentralised clinical trials (DCTs), which use digital technology to shift routine trial activities away from distant study sites. Tools such as mobile apps, interactive e-consent platforms, wearables, and video conferencing can enable at-home data collection and consultations with clinical staff.

This added convenience not only has the potential to improve participant retention but can also strengthen inclusivity in clinical trials. The logistical burden of traditional trials has led to exclusion of key demographics from clinical research. Historically, 70% of clinical trial participants have been white males, and trial diversity remains a major issue within my own field of cardiology – contributing to poorer health outcomes in women and ethnic minority groups.¹

DCTs can help remove barriers to enrolment, by reducing conflicts with work and caregiving responsibilities, minimising transportation challenges, and lowering time and financial burdens on participants.

By utilising smart monitoring devices and wearable technology (like smartwatches, for example), these innovative trial designs can collect data more efficiently and comprehensively than traditional site-based visits allow.

Additionally, the use of routinely collected data, that is primarily documented in everyday practice rather than for research, offers further potential to improve upon standard randomised controlled trials. In this sense, routinely collected data can speed up screening and recruitment, enable efficient endpoint ascertainment and decrease the burden on research teams and trial participants.

Finally, it is important to avoid unnecessary and unjustified complexity in clinical trials. In most cases, large, simple trial designs—focused on a relevant clinical question, with data collection limited to the most important variables to answer this question and conducted in broad patient populations—and pragmatic trials, which assess the effectiveness of interventions under real-world conditions, are best suited to provide reliable answers to clinicians’ questions. When embedded within registries and routine clinical practice, these trials can also be delivered more efficiently, both in terms of time and cost.

Lockdown and social distancing during the COVID-19 pandemic has accelerated the implementation of innovative clinical trials, but we still have a long way to go. To ensure the success of such clinical trials moving forward, issues related to quality, data protection, digital literacy, and regulatory preparedness must be addressed.

The future of innovative clinical trials is promising, offering several benefits to patients, researchers and industry. Through innovative methods, we can improve the patient experience, generate more comprehensive data, reduce costs, and ultimately, ensure better health outcomes for all patients.

Reference

1. Zannad F, Berwanger O, et al. How to make cardiology clinical trials more inclusive. Nat Med. 2024 https://doi.org/10.1038/s41591-024-03273-3