A lack of recruitment

One of the key challenges to the success of clinical trials is patient recruitment. Statistics suggest that 11% of study sites will not recruit a single patient into a trial. Moreover, in Europe and the US, only 1% and 2% of patients, respectively, reportedly know about clinical trials that may be available to them and that participation may be an option.1

What is preventing these individuals from participating? One contributor is the cost- and time-intensive nature of the trials (with patients frequently needing to visit a hospital or a clinic, potentially sacrificing time spent at work or partaking in hobbies). This can often deter individuals from enrolling. Additionally, rudimentary data collection methods, indigestible trial consent forms and a lack of patient-centric trial designs may also impact patient recruitment and mean that many drop out mid-trial.1–3

Financial strain

The need to conduct large scale clinical trials has placed a vast economic burden on the pharmaceutical industry for decades. Alongside patient recruitment, there are additional challenges of adherence to treatment, increasing complexities and price of on-site monitoring, while rising pressure from payers and regulatory bodies for proof of value as well as efficacy places additional stress on companies.2,3 It’s estimated that around 80% of pharmaceutical trials do not meet enrolment deadlines, causing an average daily loss of up to $1.3 million for a given drug candidate. Around 37% of clinical study sites miss their enrolment targets, while 10% cannot recruit a single study participant. Non-adherence to treatment protocols is seen in around 35% of patients, costing roughly $1 million for each trial, solely due to lost productivity.3

The potential for mHealth and wearables

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has pledged to improve Europe’s access to medicines through the use of digital solutions including remote trials, digital patient engagement solutions and digital endpoints as clinical endpoints.4 Wearable digital technology may be a means to achieving this. Thanks to advances in mobile health (mHealth) technology in recent years, mobile devices and wearables are now able to collect a wide range of physiological data from patients remotely. Individuals’ respiration rate, heart rate, oxygen saturation, sleep and activity data, and continuous glucose levels (just to name a few) can now all be monitored from the comfort of their own home.5 So what’s stopping us from utilising this technology in clinical trials? For some trials, the incorporation of mHealth devices and wearables into trials could allow individuals to participate from any location they desire, while reducing costs of on-site monitoring and helping to demonstrate real-world efficacy outside of a clinical trial environment.3 Wearables can collect continuous streams of data as people go about their daily life, while having the ability to create a holistic portrayal of an individual with the incorporation of every day data regarding factors such as diet and weather.3,6

We’re already beginning to see the potential of such technology in the clinical trial space. One phase IV clinical trial in diabetes (VERKKO) used a remote clinical trial platform integrated with a 3G-enabled wireless blood glucose metre, and subsequently spent 66% less time in study coordination activities while improving adherence rates by 18%. If these rates of improvement were applied to other, more costly therapy areas such as pain and anesthesia trials, for each study, companies could potentially save up to $10 million with such strategies.3

Barriers to uptake

With the use of such technologies in healthcare inherently comes new challenges. Widespread uptake may be limited by a variety of legal, ethical, regulatory, and security barriers. For instance, device engineers may not be familiar with the drug development process and regulatory requirements for treatment approvals and potential cyber threats may threaten data privacy and security.6