Our industry seeks to make trial participation simpler, more convenient and more patient-centric. One of the enablers of this simplification is the novel use of new technology.
For example, we already see a drive to use remote monitoring solutions and wearable sensors to enable the collection of rich, informative data about the patient and their condition in their home environment, potentially reducing the number of in-clinic visits a patient may be required to attend.
More and more trial participants own a mobile device, and there is a drive to enable study apps, such as those collecting patient-reported outcome data, to be installed on their own devices (BYOD) as opposed to asking them to carry and maintain a second device during the study.
In addition to the rise in mobile and wearable solutions, we see greater numbers of consumers using Voice Assistant technologies such as Amazon Echo and Google Home. Gartner predicts that by 2020, 30% of web browsing sessions will be done without a screen [1], using either Voice Assistants or Virtual Reality. This trend is demonstrated by a 130% rise in US sales of voice-enabled devices such as Amazon Echo and Google home, with over 10% of Americans using a voice-activated assistant device at least once a month [2].
Voice Assistant technologies provide an opportunity to create a different level of engagement and interaction in comparison to regular apps and web pages. Voice commands and conversational applications offer a refreshing, simplified and engaging alternative to the pinching, scrolling and tapping required by smartphone apps.
In addition, voice-controlled applications may remove barriers to use, particularly for those that find operation of a mobile device difficult or fiddly, or have low functional literacy.
Conversational applications leveraging Voice Assistants may be of particular value where continued patient interaction and engagement are important. Application areas could include patient training, information and consent, patient engagement and retention, and the collection of patient-reported outcome data and other trial-related information directly from the patient.
Alexa, complete my diary…
Developers within ICON’s dedicated Innovation team have developed a proof-of-concept application operating on the Amazon Echo platform that leverages a Voice Assistant to deliver a patient-reported outcome instrument and collect patient responses.
The purpose of the early research project was to explore the capabilities of the platform, understand how to program applications, and to consider the kind of applications that would be feasible to deliver in future within our highly regulated environment.
Operating in multiple languages, initial informal testing of the application, which is launched using the command “Alexa, complete my diary”, has indicated that the platform is able to operate robustly with multiple users and languages with minimal training.
When it comes to collection of patient-reported outcomes there is more work to do in terms of ensuring measurement equivalence to standard formats, but there is already a growing body of evidence showing that instrument migration from paper to electronic formats including voice (e.g., Interactive Voice Response Systems) can be accomplished without changing the instruments measurement properties.
However, the development of conversational applications may provide an effective way of interacting with patients in an engaging manner in many other ways in future clinical trials. Imagine a Voice Assistant becoming your personal trial assistant – providing reminders for upcoming visits, arranging concierge services to get you safely to site, providing study information, managing the trial consenting process, letting you know when to take medication, and delivering patient-reported outcome instruments and other at-home assessments on schedule.
This may offer a much more engaging approach compared to current methods which may have a positive impact compliance, recruitment and retention.
ICON continues to focus on the factors that are critical to transforming trials for future success, including exploring how to best leverage new technology in novel ways to provide rapid access to, and analysis of, high-quality data to speed and improve decision making in clinical trials. This work is one part of a programme of innovation projects exploring patient-centric approaches and trials of the future at ICON.
[1] Gartner (2017). Gartner’s Top 10 Strategic Predictions for 2017 and Beyond: Surviving the Storm Winds of Digital Disruption.
[2] eMarketer (2017).
In this section
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Digital Disruption
- AI and clinical trials
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
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Digital disruption in biopharma
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Disruptive Innovation
- Remote Patient Monitoring
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Personalising Digital Health
- Real World Data
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The triad of trust: Navigating real-world healthcare data integration
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Patient Centricity
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
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Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Agile Clinical Monitoring
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Regulatory Intelligence
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An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
- Regulatory Intelligence Newsletter
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Requirements & strategy considerations within clinical trial transparency
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Spotlight on regulatory reforms in China
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Demystifying EU CTR, MDR and IVDR
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Transfer of marketing authorisation
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An innovative approach to rare disease clinical development
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Therapeutics insights
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Glycomics
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Respiratory
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Rare and orphan diseases
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Advanced therapies for rare diseases
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Cross-border enrollment of rare disease patients
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Diversity, equity and inclusion in rare disease clinical trials
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Identify and mitigate risks to rare disease clinical programmes
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Leveraging historical data for use in rare disease trials
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Natural history studies to improve drug development in rare diseases
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Patient Centricity in Orphan Drug Development
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The key to remarkable rare disease registries
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Therapeutic spotlight: Precision medicine considerations in rare diseases
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Advanced therapies for rare diseases
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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Linguistic validation of Clinical Outcomes Assessments
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Optimising biotech funding
- Adaptive clinical trials
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Best practices to increase engagement with medical and scientific poster content
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Decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Navigating the regulatory labyrinth of technology in decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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eCOA implementation
- Blended solutions insights
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Implications of COVID-19 on statistical design and analyses of clinical studies
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Improving pharma R&D efficiency
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Increasing Complexity and Declining ROI in Drug Development
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Innovation in Clinical Trial Methodologies
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Risk Based Quality Management
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Transforming the R&D Model to Sustain Growth
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Accelerating biotech innovation from discovery to commercialisation
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Value Based Healthcare
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Strategies for commercialising oncology treatments for young adults
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US payers and PROs
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Accelerated early clinical manufacturing
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Cardiovascular Medical Devices
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CMS Part D Price Negotiations: Is your drug on the list?
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COVID-19 navigating global market access
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Ensuring scientific rigor in external control arms
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Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
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Global Outcomes Benchmarking
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Health technology assessment
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Perspectives from US payers
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ICER’s impact on payer decision making
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Making Sense of the Biosimilars Market
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Medical communications in early phase product development
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Navigating the Challenges and Opportunities of Value Based Healthcare
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Payer Reliance on ICER and Perceptions on Value Based Pricing
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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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RWE Generation Cross Sectional Studies and Medical Chart Review
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Survey results: How to engage healthcare decision-makers
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The affordability hurdle for gene therapies
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The Role of ICER as an HTA Organisation
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Strategies for commercialising oncology treatments for young adults
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