Driving clinical trial innovation forward with precision medicine

Late last year, pharmaphorum spoke with AstraZeneca’s Ben Challis, VP and head of translational science and experimental medicine, cardiovascular, renal, and metabolism (CVRM), together with Magnus Jörnten-Karlsson, executive director of Unify.

Unify, launched in December 2020, is AstraZeneca’s patient app and clinical trial support tool. Already, it is operating at scale across the company, used in more than 28 countries and available in 62 languages.

Dissecting heterogeneity

To begin discussions, pharmaphorum asked the executives about AZ’s innovation drive in precision medicine.

“Attrition in drug development for chronic disease is high, often because the wrong patients are selected for clinical trials,” Challis explained. “Precision medicine can help us to tackle this issue, enabling us to select patients for the most appropriate clinical trials based on their underlying disease biology and the drug’s mechanism of action.”

“Chronic diseases are heterogeneous and complex,” he continued. “Dissecting this heterogeneity is the focus of current research efforts at AstraZeneca, and this information can be directly used to identify molecular biomarkers that will stratify patients.”

Digital technology and ‘frictionless’ clinical trials

The explosion of digital technologies has assisted with the development of medicines in recent years , opening avenues for meeting patients where they are and permitting ‘frictionless trial experiences’ – essentially, decentralised trials.

“Clinical trials are currently moving away from 100% reliance on clinical labs, and towards improved home testing,” said Jörnten-Karlsson. “But, to truly transform healthcare for society, our long-term vision involves continuous monitoring of patients’ vital signs and general health. It is this which will one day encourage early detection of disease and lead to improved outcomes for our population.”

“[Patients] may be geographically isolated or […] unable to access a clinical trial site easily due to the severity of their disease,” Challis expanded. “We’re aiming to create frictionless trial experiences, which in essence means meeting the patient where they already are.”

“Even where patients do have to travel to a site, Unify helps them prepare for their visit by providing details of what the visit will entail,” he said.

In that instance, the company aims to remove the need for patients to organise their own transport by providing taxis and childcare during trial visit periods.

Drop-out rates and data collection

“[Around] 15% of patients drop out, mainly because of the burden on their everyday lives and medical reasons beyond the control of the trial,” Jörnten-Karlsson said. “Making the process frictionless will, hopefully, encourage an uptake in participation and reduce the need to re-recruit lost patients.”

“Our main goal here is to apply innovative technology in clinical trials, as well as in real world, to transform healthcare,” he explained. “In the future, we hope to be able to extend the frictionless experience beyond the execution of the trial itself, connecting with patients both before and afterwards.”

“Thanks to the ability to monitor new endpoints through more frequent remote data collection, we’ll be able to change how we characterise diseases and our medicines,” Jörnten-Karlsson continued. “For example, in November, Unify launched the clinical validation of remote-coached spirometry within a COPD study, helping clinicians to meet patients where they are. This is thanks to the new ability for the healthcare professionals to perform lung function tests and PEF readings via a virtual patient visit using a device connected with Unify.”

Additionally, the data from the device is displayed in the HCP Unify web portal in real time. This enables the HCP team to ensure they have a robust result while the patient is still with them virtually – a boon for patients, stats showing interest in joining clinical trials is waning, with between a mere 3% and 5% of eligible individuals taking part.

Future waiting rooms

Unify is already incorporating features such as telehealth, direct-to-patient supply, medication reminders, remote data collection, and connected devices – AstraZeneca is also building digital waiting rooms in order to offer patients a means by which to stay connected to potential future research and more quickly find the best trial for them.

“The major functionality upgrades in the development plan for 2023 include eConsent, aimed at making it more straightforward for patients to consent as part of the clinical trial design, ECG Measurement and vital signs monitoring, and home testing for kidney disease via a connected device,” Jörnten-Karlsson told pharmaphorum.

About the interviewees

Magnus Jörnten-Karlsson, executive director of Unify at AstraZeneca, oversees the development and implementation of digital tools for patients and clinical sites that have the potential to transform clinical research for patients. He currently leads the development of AstraZeneca’s first Digital Patient Solution called Unify, a transformative end-to-end digital solution that virtually connects all clinical trial participants. Jörnten-Karlsson has more than 30 years’ experience in the pharmaceutical industry spanning a range of areas, but since 2013 he has focussed his career within digital health and digital therapeutics.

Ben Challis, vice president and head of translational science & experimental medicine, Cardiovascular, Renal, and Metabolism (CVRM) at AstraZeneca, leads the company’s human target validation, biomarker, and precision medicine departments. A practising physician, he works closely with team leaders in both early and late CVRM research. Challis helps to direct the early-stage research priorities in CVRM and is involved in a multitude of initiatives across the early CVRM portfolio.