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With clinical trials forming the lion’s share of the costs of drug development, there is constant drive and demand for technological innovation oriented towards reducing costs, increasing efficiency and enabling new paradigms within clinical development. At the Clinical and Research Excellence (CARE) Awards, the vital importance of these advances will be recognised during the Awards for ‘Best Sponsor-Focused Technological Development’ and ‘Best Patient-Focused Technological Development’. In this piece we will look at an emerging trend within the clinical landscape, ‘smart tech’ and the related ‘internet of things’ and its impact on the industry. The ‘internet of things,’ i.e. the interconnectivity of computing devices and sensors integrated into normally mundane objects, [1] sometimes dubbed the ‘third wave of the internet’ is predicted to vastly increase over the next few years as the technologies involved mature.

 

With remote-only clinical trials now a reality [2] despite the inherent difficulties posed by the format, the digitisation of Pharma is closer than ever. Many categories exist into which software and devices can be divided to and differentiate them by the availability/ubiquity and intrusiveness to the patient.

 


Connected computing & communications

The interconnectivity of the modern world is slowly beginning to make itself felt in the domain of clinical trials. Worldwide, the number of smartphones and users has passed two billion in 2016 [3], with the number only forecast to grow as market penetration and affordability continues to increase. Most smartphones come standard with various capabilities, including location tracking, gyro/accelerometer functions, a camera and of course the ability to record and receive/transmit data. Due to the ubiquity of these capabilities, trials designed to measure variables that can be self-reported, often in real time, allow patients to communicate with their healthcare provider or simply log events for later review, while other common capabilities allow monitoring of additional data points like activity levels, hospitalisations (geotracking) and document symptom development using the device’s camera.

 

Improvements in patient recruitment have also been demonstrated using smartphone apps. Researchers at Stanford University using Apple’s ResearchKit enrolled over ten thousand patients in a day for a cardiovascular study, a feat that stunned the team as a trial this size in this therapeutic area typically requires a year and 50 medical centers to complete recruitment. [4]

 

The good news for companies intending to develop within this space is that the FDA and other regulatory bodies are favouring a ‘hands off’ approach [5] to regulating applications which allow common devices to be used for medical functions, intending to only regulate if there is a degree of risk to the patient should the application or device fail to perform as expected.


The smart sensing wearable

Less common than smartphones but still found in widespread use in non-medical contexts are specialised devices like fitness wearables and health monitors. These commonly include heartrate or blood pressure monitors, as well as gyro/accelerometers to measure activity. Other more estoteric uses like using a phone/wearable’s vibrate function to measure body fat are also under development. [i] Commercial devices, such as wristbands produced by Fitbit, Apple, Microsoft, Garmin and others, are already widespread and sales are predicted to only increase over the coming years [6]. The use of commercial wearables in clinical trials is already a reality, for example Fitbit’s health trackers were used in a study looking at weight loss in cancer patients. [7] This use of tech to monitor variables in trials with more granularity and ease than previously possible is the first step in technological integration and likely heralds more to come as the tech involved proliferates and matures.

 

The mobile medical device

The final type of device considered are more specialised devices, usually developed for treatment of a particular indication. There are numerous examples of these and the line between traditional medical devices and those with integrated tech can be difficult to delineate. Often these devices will be regulated as medical devices under the current guidance with the associated regulatory burdens.

 

Many types of traditionally ‘dumb’ medical devices are now being developed with ‘smart’ and connected capabilities, some are designed as add-ons to existing devices which can allow them to sidestep regulation as medical devices such as Aterica’s Veta smart case for EpiPen auto-injectors. This syncs with a user’s smartphone and is capable of alerting caregivers when the injector is removed from the case and, if not deactivated correctly after opening, can even alert emergency services of the user’s location and status via its link to a smartphone (it is designed to assume a user is incapacitated by anaphylaxis).

 

Specialist yet non-intrusive examples include devices like the Emphatica seizure watch which monitors the patient’s physiological data and updates this in real time to a database which can then be analysed for patterns and warning signs of seizures. The real-time capabilities of Emphatica also allow caregivers to be alerted during seizure events in a similar way to the Veta case detailed above, allowing patients to have greater freedom and flexibility within their treatment plan as well as providing reassurance for any caregivers.

 

Monitoring systems capable of allowing remote monitoring of patients are also under development, gathering continuous clinical data from patients even when they are off-site, is the goal of systems like MC10’s BioStamp which is a low profile, wireless monitoring system capable of logging patient biopotential and movement information and relaying it to a clinical team from anywhere with wireless communication capability. More unusual variants are those like the ‘chip-in-a-pill’ system from Proteus Health which allows doctors to monitor patient compliance with medication regimens remotely via a sensor embedded in the medication that can sense ingestion, report this to the physician and log the information for later review.

 

Obstacles to connecting the dots

The ubiquity of mobile connectivity in modern society, which allows new ways to gather data and engage patients, is the key factor connecting all these developments in technology to clinical research and reporting. Real-time, objective data access, for both patient and clinician, better patient enrolment capabilities, increased patient engagement and compliance, as well as better monitoring of study subjects and data flows for a lower price tag are all outcomes promised by this new wave of development.

 

However, multiple issues must be addressed with the use of connected tech, especially in clinical trials where accuracy and quality of the data collected is paramount. Access and reliability of technology is an issue, cellular network coverage and user access may be restricted in some areas and devices are vulnerable to loss, damage or even security breach by external parties, all of which will interfere with consistent data generation. Similar issues can arise with attributability since it could be difficult to verify whether the user of a device at any point is actually the trial participant. Privacy concerns of subjects are also a major issue; for example, participants may not be comfortable with continuous location tracking or other data monitoring. This gives rise to issues where they disable such services from their device leading to gaps in the data collected. Differences between how data is logged between participants is also an issue. What one participant considers worthwhile to be logged may differ significantly from another, a challenge shared with other subject-diary style trials. Devices may also be calibrated differently leading to issues with analysis of collected data.

 

Once the data is recorded more issues may arise with interpretation. The sheer volume of trackable information poses its own unique challenges. Clinical interpretation can be a challenge as the vast amount and often real-time nature of the data will likely exceed the previous experience of many Clinicians, so guidance and training for new techniques will need to be developed.

 

Smart clinical tech and the ‘internet of things’ has been the focus of much attention over the last years. Whether it will live up to the predictions of some of its proponents and cause transformative change within the industry or simply become another tool in a clinician’s arsenal remains to be seen but the promise of change is an exciting one and the industry must be prepared for whatever comes.

 

As previously mentioned, a selection of technological developments supporting pharma R&D will be recognized during the CARE Awards ceremony, taking place on April 5th, 2017 at The State Room in Boston. Two categories will celebrate such achievements, with the following finalists who have developed innovative technologies to help study teams better manage and oversee clinical trial activities, advances that improve patient data collection, or the patient experience in a trial.

 

Best Sponsor-Focused Technological Development
Covance, Xcellerate® Medical Review
Cytel, East 6.4 Team
goBalto, goBalto Select
IBM Watson Health & Novartis & Highlands Oncology, Watson Clinical Trial Matching Team
Medidata Solutions, Medidata Balance: Pooling Trial Supplies at Sites

 

Best Patient-Focused Technological Development
AMRA, AMRA® Profiler Research
CRF Health, TrialConsent™, electronic informed consent platform
NorthWest EHealth, Linked Database System
PAREXEL International, Consent+

For more information about the Clinical and Research Excellence (CARE) Awards, including how to book a table or sponsorship opportunities, please visit clinicalresearchexcellence.com

 


[1] Dormehl (2014) https://www.theguardian.com/technology/2014/jun/08/internet-of-things-coming-together-tech-revolution. The Guardian.
[2] Fassbender, M (2016) Entirely remote online clinical trial has 'significant benefits' Outsourcing-Pharma.com
[3] Statista (2016) https://www.statista.com/statistics/330695/number-of-smartphone-users-worldwide/. Statista.com
[4] Cortez MF, Chen C (2015) Thousands Have Already Signed Up for Apple's ResearchKit. Bloomberg Technology.
[5] FDA (2015) Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff
[6] Beaver (2016) http://uk.businessinsider.com/smartwatch-and-wearables-research-forecasts-trends-market-use-cases-2016-9?r=US&IR=T. Business Insider.
[7] Wasserman E (2016) Fitbit lends wearable tech to Dana-Farber for breast cancer study. Fierce Biotech.

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