Decentralized Clinical Trials of Investigational Medicinal Products 

This peer-reviewed paper reviews the state of decentralized clinical trials, identifies the barriers preventing the incorporation of passive real-time data collection via digital health technologies (DHTs), and proposes four concrete solutions to unlock the full potential of this approach. The work draws on a multidisciplinary workshop attended by more than 120 experts from 30 organizations across academia, industry, regulatory agencies, patient advocacy and CROs. 

Highlights 

• Fewer than 0.1% of the 4,874 decentralized trials registered on ClinicalTrials.gov in 2023 were to investigate a medicinal product, despite the promise of wearables and remote monitoring 

• Regulatory complexity, patient-device interface challenges, device capability gaps, and data security requirements are the key barriers 

• Four actionable recommendations are made: create fast-track regulatory pathways for DHTs in clinical trials, develop purpose-built DHTs for clinical trials, integrate human factors into DHT design, and adopt interoperable data collection and transmission standards 

Authors 

Abdel Douiri (King’s College London), Mohamed A. Alhnan (King’s College London), Muhammad Rizwan Asghar (University of Surrey), Konstantinos Balaskas (University College London), Faiza Benaouda (King’s College London), John Bolodeoku (King’s College London), Clare Campbell-Cooper (Fortrea), Camille Carroll (Newcastle University/NIHR), Tao Chen (University of Surrey), Keith Dorricott (Dorricott MPI), Thierry Escudier (Pistoia Alliance), Carsten Flohr (King’s College London), Ben Forbes (King’s College London), Richard H. Guy (University of Bath), Stephanie Langouet (King’s College London), Anthony Lockett (King’s College London), Rayka Malek (King’s College London), Angela May (Bayer), Graham R. McClelland (King’s College London), Sara M. Nasereddin (Amman Arab University), Alejandro J. Paredes (Queen’s University Belfast), Sheuli Porkess (PM Life Sciences Consulting), Eddie G.M. Power (emPower Medical LLC), Richard E.K. Russell (King’s College London), Richard Stephens (Patient Advocate), Heba Sailem (King’s College London), Daniel Sebastia-Saez (University of Surrey), Matthew R. Sydes (UCL and Health Data Research UK), John Weinman (King’s College London), Yunlong Zhao (Imperial College London), and Stuart A. Jones (King’s College). 

Why are so few drug trials decentralized? 

The clinical trial sector has invested heavily in digital health tools for DCTs, but almost none of this investment has reached the trials that matter most for drug approval. The authors found only seven large prospective DCTs using real-time DHT data collection, of which just two used passive, continuous monitoring as a primary endpoint. The reason is not a lack of technology, but rather a set of interconnected regulatory, human, and technical barriers that are rarely addressed together. This paper examines each of them in depth. 

What are the barriers? 

Regulatory guidance for DHTs in clinical trials for investigational medicinal products is fragmented and inconsistent, creating confusion about what data are needed to support a device’s use in a trial. Patient concerns about digital technologies replacing personal care, privacy risks, and device burden are real and largely unaddressed by current DCT designs. Consumer-grade wearables often fail the accuracy and security standards required for clinical trials. And because very few decentralized trials generate objective outcome data, the evidence base needed to justify the investment remains thin. The paper presents a risk-cost matrix and innovation matrix to help navigate these trade-offs. 

What are the proposed solutions? 

The authors call for four coordinated changes: a fast-track regulatory pathway specifically for DHTs used in clinical drug trials; incentives to develop purpose-built DHT platforms for decentralized drug trials rather than adapting consumer devices; DHT design processes that embed human factors and patient experience from the outset; and industry-wide adoption of data collection and transmission standards to enable home-based trials to function reliably and securely at scale. These changes require collaboration across sponsors, regulators, technology developers, clinicians and patients. 

Our colleague Thierry Escudier contributed to this publication, bringing insights from the Clinical Trial Environmental Impact project to the discussion on the sustainability of decentralized trials.