New technologies allow decentralisation of clinical trials

  • Posted on 26.02.2019

New technologies allow decentralisation of clinical trials

Sorin STIRCU - BioPic

Sorin Stircu

Regional MedTech Strategist at E*HealthLine - Europe Global Office


Emerging technologies, innovative software and medical devices are revolutionising the healthcare industry. Decentralising clinical trial data is helping to unlock the full potential these tools by enabling people in different places to work securely on data without compromising patient privacy.

One of the areas that I find most exciting is the use of predictive modelling and artificial intelligence in federated machine learning – a way to learn from data without removing it from the location where it is stored.

This takes us beyond the current established concept of federated databases. By combining several new technologies, we can not only have distributed data – but also distributed ‘data fictionalisation’ (i.e. the learning from data). This enables owner control of the data during learning.

In practice, this disruptive approach ensures that the study is built around the patient, rather than a centralized trial site. It unleashes new ways to use data, transforming how scientists conduct R&D in the discovery and management of various diseases.

This new patient-centred approach means data can be collected anywhere – at a hospital or research centre, or from the patient’s home using telemedicine tools. This produces data that is far more representative of a patient’s real-world activities during their participation in a clinical study.

Building clinical trials around patients in their homes and in the community through remote visits and monitoring, enhances recruitment and increases convenience for participants. The implementation of this decentralised research approach is well accepted by patients, offering measurable benefits. It means fewer site visits, making trial participation less daunting.

Today’s remote advanced technologies have provided many opportunities for healthcare organizations to enhance the overall care experience, improve the health of populations and reduce per capita healthcare costs, globally.

As a result, we have seen readmissions among congestive heart failure (CHF) patients in a remote-patient monitoring (RPM) programme drop to 12%-14%, compared to 20%-22% for a non-RPM cohort of CHF patients.

Wearable devices, sensor and mobile technology have enormous potential to collect information on blood pressure, heart rate, and weight, but some researchers have been slow to incorporate them into clinical trials. The traditional site-based approach prevails – meaning that there is significant untapped potential to use technologies to improve study design, enrolment and patient engagement.

Payers will benefit too, as studies produce measurable data to support the value proposition of therapies, while sponsors benefit from condensed timelines and accelerated time to market.

We must work together across the healthcare sector to accelerate uptake of these tools into clinical studies. There is more progress on the horizon as diagnostics, AI algorithms, and electronic health records promise to further decentralise research and care. As Jacques Demotes, Director General at European Clinical Research Infrastructure Network (ECRIN), said “Clinical research is currently undergoing a digital revolution with the use of genetics and imaging technology to generate large multimodal datasets, allowing data driven patient stratification through AI algorithms, to share and reuse cohort and registry data as well as electronic health records to run clinical trials, and to conduct decentralized trials using electronic data capture at the patient’s home”.

I believe that investing in building consortiums with academia, industry, research organisations and with patients, will improve how we use the tools we have and prepare us to embrace new technologies. Innovative digital tools and blockchain technology will further enhance the quality of trial data and the patient experience.

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