IN PARTNERSHIP


The evidence for decentralised trials


Huma’s Mert AralDr Arrash Yassaee, global clinical director, look at how a groundbreaking trial, run entirely remotely, found rapid recruitment, high engagement, and that patients with low baseline increased their medication adherence from 85% to 96%.


 clinical trials


 new treatment is approved, generally involve hundreds or thousands of people. Manual recruitment of participants in these trials  commitment for both the organisation and trial participants. Participants usually have to travel to a clinical site for treatment and follow-up, which places an additional burden on them and may exclude participants who cannot travel for location, cost or health-related reasons. As a result, conventionally run clinical trials often encounter challenges in recruiting and retaining participants. In a large review of randomised controlled trials (RCTs), only 63% achieved their target sample size, and the original recruitment target had to be revised in 30% of studies. This review also found a participant dropout rate of at least 10%(1) The COVID-19 pandemic brought the


.


challenges of the traditional clinical trial to the fore. It created an immediate need to reduce person-to-person contact, especially for people with underlying conditions, who are likely to be overrepresented in the population taking part in clinical studies.


This meant that far fewer participants were recruited to take part in trials and, for those trials already ongoing, data collection visits were greatly reduced. In April 2020, there was an 80% drop in new patients entering trials in the US compared with April 2019(2)


. Much of this disruption may have been


prevented using a different type of clinical trial: a decentralised clinical trial or DCT.


40 | Outsourcing in Clinical Trials Handbook


   of a fully decentralised clinical trial (DCT) saw rapid recruitment (94% in 12 days) and high engagement, and that patients with low baseline increase their medication adherence. The study, known as DeTAP, led by the Stanford School of Medicine in collaboration with researchers at Bayer and Huma Therapeutics, highlights the huge potential for decentralised trials. DeTAP was a six-month, single-arm, 100%


virtual study of 100 patients with a heart condition that causes an irregular and often abnormally fast heart rate, known as atrial  over and were on oral anticoagulation (OAC) medication. There were no in-person visits or measurements during the study. Participants enrolled and participated through an app and were sent remote blood pressure (BP) and electrocardiogram (ECG) sensors. The app collected the data and enabled reminders, surveys, educational content and video calls. The trial was led by principal investigator


Rajesh Dash, MD, PhD, associate professor of medicine at the Stanford School of Medicine. 


rhythm disturbance, causing more than 450,000 hospitalisations in the US each year(3)


, and


many patients are given medication to prevent a stroke. However, up to 30% of patients do not adhere to their medication(4)


.


Patient engagement may be key to improving adherence, and, in this DCT – which enabled more frequent contact, reminders and interactions – patients with low baseline


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