ORIGINALLY PUBLISHED
26 September 2023
Written by:
Chief Digital Health Officer R&D, Astrazeneca
VP Digital Health, BioPharmaceuticals R&D, AstraZeneca
The rapid and continued evolution of digital technology has enabled new digital healthcare solutions for clinical trials; this has the potential to transform clinical study design, the experience of patients and trial site teams, improve clinical outcomes, reduce timelines and burden for participants and improve environmental sustainability. By starting with patient insights, combining different technologies for remote data collection and utilising connected devices, we are enabling new endpoints and ways of collecting data and are making it easier for patients and investigators to participate in our trials.1
Why do we need to embed digital health solutions in clinical trials?
Clinical trials are the cornerstone for delivering the next generation of therapeutics. However, healthcare environments are becoming increasingly complex, leading to new challenges for clinical research, including patient recruitment, retention and diversity. There was an upsurge in the application of digital health solutions in delivery of healthcare during the COVID-19 pandemic, which catalysed and accelerated changes in clinical trial recruitment and participation.
These changes were well aligned with our focus on digital patient and site solutions; we are now leveraging these approaches to ensure that our trials are designed and delivered with patients and site teams at the centre, with the aim to support health equity and inclusion and to deliver better outcomes faster and in an environmentally sustainable way. Once patients are enrolled in a trial, digital health solutions have the potential to make participation considerably less burdensome – for both patients and trial teams.
How do we design digital health solutions for clinical trials that reflect patient needs?
To better understand the experience of participating in clinical trials, we conducted qualitative research with over 300 patients, caregivers, and trial investigators from nine countries.1 These insights allowed us to identify the 14 ‘moments that matter’ to our patients, including multiple opportunities to improve the patient experience across our clinical trial processes by incorporating digital-based solutions into the trial design. We have also developed bespoke tools such as Merlin, which can provide an automatic score to estimate the likely patient experience index for the study – based on the study design and feedback from patients on the burden of visits and procedures within the study.
We can use this index to compare new study designs with those of similar previous studies, in order to improve the patient experience; moreover, the score can also provide information on the costings, timelines and greenhouse gas emissions. When we improve the patient experience, this can improve outcomes across these areas – correlating with accelerated timelines, lower costs and lower greenhouse gas emissions.
We also evaluate patients’ experiences in our trials through measures such as our Rare Disease Patient Friction Co-efficient measure. By integrating these different insights and tools, we can design digital health solutions that are truly patient-centric.
How digital health solutions, AI tools and remote data collection drive innovation in our trials
In the future, many of the assessments currently collected during in-person clinical trial visits to a medical institution could be collected from patients at home using digital technologies. Traditionally, clinical trials follow a site-based model of ‘on-site’ in-person patient visits for recruitment, interventions, assessments, and follow-up. This represents a significant burden for many patients, such as spending time travelling and waiting in the clinic, as well as having to pay for transport and parking or taking time off work. We reviewed 91 clinical trial protocols for studies in oncology, respiratory, and cardiovascular disease and concluded that 74–85% of trial assessments could be successfully collected remotely using clinically validated devices; this could reduce the number of physical visits to the clinic by up to 40%.1 To reduce these burdens, we are developing a range of digital health solutions, AI tools and remote data collection technologies – informed by our research into patient needs and preferences.
One of these solutions is Unify – our bespoke digital platform developed for patients and clinical trial teams to support trial participation, patient accessibility (e.g. through virtual consultations at home), and remote data collection, monitoring and management of events.
For example, clinical trials in patients with chronic obstructive pulmonary disease (COPD) traditionally require that patients’ lung function is measured by a breathing test called spirometry in research clinics. Using Unify, we can enable the monitoring of spirometry at home to the same quality as in the clinic. The use of digital tools in one of our trials in COPD is predicted to reduce treatment duration and the number of in-person visits by 50%, and lead to a 15% reduction in overall trial duration, a 32% reduction in costs, as well as an expected 68% improvement in the patient experience index.1
We have also developed AIDA (Automatic Identification Detection Adjudication), an AI solution that can support the automated detection, reporting and assessment of key outcome events in our cardiovascular trials. AIDA supports us in the identification of cardiovascular events much more rapidly than would traditionally be the case when waiting for patients or their family to report events to the investigators; AIDA also supports the clinical site teams in collating and curating the relevant reports and providing adjudication of events.
Similarly, we are currently exploring different digital health solutions in several of our oncology trials, including for recruitment, consent, assessment of outcomes, and remote monitoring of symptoms – to support patients and their physicians in the management of those symptoms and with ongoing treatment.
Building a data infrastructure to enable digital innovation in our trials
All these new digital health solutions result in a significant increase in the amount and diversity of data generated in our clinical trials – such as data from imaging, devices (such as spirometry), or genomics. We are therefore investing in the data infrastructure and systems that help us improve how we gather, analyse and utilise the information collected in our trials.
For example, we are increasingly standardising our approaches and the templates for our clinical trial data; these innovations in data collection and analysis help us better manage the extensive data flow in our trials. Our improved data engines also help us lock our clinical trial databases faster once a trial is completed, and accelerate submission timelines of our trial data to regulators.
Our ambition for digital health solutions in clinical trials
Our approach to digital health in clinical trials means more than just introducing new digital health solutions such as apps or sensors alone – it is about combining these tools in a seamless manner with different ways of working with patients and investigators to design and deliver clinical trials that better support everyone involved.
Our mission for clinical innovation at AstraZeneca is to design and deliver patient-centric clinical trials that improve the patient and site team experience, and to use data, digital and AI to gain earlier insights and improve patient outcomes – all to help us deliver the next generation of life-changing medicines for patients faster than ever before.
