- Home
- Insights
- Digital Disruption
- Bring Your Own Device
Bring Your Own Device
Are the barriers of patients using their own mobile devices, myth or reality?
It is unclear whether “Bring your own device” BYOD, will lead to significant cost savings, but reducing logistics is likely to make study management less complex. More importantly, BYOD promises greater patient-centricity by enabling patients to conduct assessments using the convenience and familiarity of their own hardware devices.
BYOD is a topic often discussed in the context of electronic clinical outcome assessments (eCOA) but there has been limited use of BYOD in regulatory studies to date and common perception is that delay in uptake is from two main concerns:
- Measurement equivalence: The differences in the eCOA instrument display due to device screen size and resolution might adversely affect its measurement properties.
- Technical and practical issues: Lack of control of the patient’s hardware, for example being unable to prevent operating system upgrades mid-study, or having no control over the device storage space availability.
BYOD survey
In order to identify and assess the perceived barriers and challenges with the use of BYOD for eCOA, ICON in association with Medidata and mProve Health decided to conduct a survey.
This comprehensive survey, of industry clinical trial and outcomes research specialists, highlighted how commonly-cited concerns around the use of patients’ own devices are not as great a deterrent to adoption as originally thought.
Seventy-nine respondents, from a range of organisations including biopharma companies (18%), CROs (23%) and eCOA vendors (34%), completed our survey in autumn 2015.
Attitudes towards measurement equivalence
Less than half the respondents (44%) agreed or strongly agreed that equivalence should be demonstrated on all possible devices used in a BYOD study; and a third (33%) disagreed or strongly disagreed that demonstration of equivalence on a single device was acceptable if access using devices of a smaller screen size or resolution could be prevented.
This echoes the growing body of evidence that equivalence across modalities and screen sizes is less problematic than previously thought, especially if eCOA design best practices are employed.
For example, a recent meta-analysis by ICON eCOA experts has demonstrated strong evidence of the equivalence of paper and electronic over multiple instruments, patient populations and electronic media. If patients respond consistently with COA instruments, whether in paper or electronic form, then it seems a reasonable inference that the subtle changes across different mobile phones should not present a significant equivalence challenge.
Attitudes towards perceived technical and practical issues
Of the 21 perceived practical/technical challenges and issues associated with BYOD use for eCOA that we considered, few appeared of significant concern to the respondents in this survey. In all cases, over half of the respondents were either “not at all concerned” or “a little concerned” on the 4-point verbal response scale. Those reporting slightly more concern included:
- The ability of patients to disable in-app notifications, such as diary reminders (53%: “not at all concerned” or “a little concerned”)
- The ability of patients to pair their phone with a BlueTooth device when required by the study (32%: “very concerned” or “extremely concerned”)
- Patient training and technical troubleshooting by the site personnel (Training burden on sites – 27% “very concerned” or “extremely concerned”; Site troubleshooting technical issues – 33% “very concerned” or “extremely concerned”).
While some concerns explored are tangible situations that could occur in a clinical trial, many can be mitigated or balanced against the benefits of enabling patients to use their own familiar and convenient devices, which may actually lead to greater compliance and engagement.
For example, it is possible to identify when push notification tokens indicate that in-app notifications have been disabled on the patient’s device, and this could enable other actions to contact the patient if their compliance with the diary schedule is an issue.
The age of BYOD eCOA
The results of this survey are encouraging and indicate a greater comfort in BYOD, and with it the opportunity for patient convenience and centricity – enabling subjects to utilise their own smartphone to maintain their symptom diaries and instrument entries – the device they already carry with them and refer to over the course of each day.
With BYOD, subjects will use a device they are familiar with and know how to use, and will not be inconvenienced by needing to carry and keep charged a separate device solely for the purposes of their eCOA entries. Previous patient preference studies have shown that the majority of patients prefer to have a single device, and this can only benefit PRO convenience, completion and compliance.
The FDA’s request for public input on the scope and direction of the use of technologies and innovative methods in the conduct of clinical investigations, closed in December 2015, includes a specific question concerning the use of BYOD eCOA. This is a positive signal from the regulators and can only help to provide better understanding of FDAs position and what additional research and development work might be needed to make BYOD a fully endorsed approach.
At ICON, we believe that we are about to enter the age of BYOD eCOA. We continue to drive research and development activity and share our findings around the use of BYOD, to help to turn the tide and improve patient engagement in clinical trials.
Latest on devices
If you would like to receive our Digital Disruption email updates, including the latest on mHealth and wearables, as well as the device market sector, click here to go to our preference centre.
In this section
-
Digital Disruption
- AI and clinical trials
-
Clinical trial data anonymisation and data sharing
-
Clinical Trial Tokenisation
-
Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
-
Digital disruption in biopharma
-
Disruptive Innovation
- Remote Patient Monitoring
-
Personalising Digital Health
- Real World Data
-
The triad of trust: Navigating real-world healthcare data integration
-
Patient Centricity
-
Agile Clinical Monitoring
-
Capturing the voice of the patient in clinical trials
-
Charting the Managed Access Program Landscape
-
Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
-
Exploring the patient perspective from different angles
-
Patient safety and pharmacovigilance
-
A guide to safety data migrations
-
Taking safety reporting to the next level with automation
-
Outsourced Pharmacovigilance Affiliate Solution
-
The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
-
Sponsor and CRO pharmacovigilance and safety alliances
-
Understanding the Periodic Benefit-Risk Evaluation Report
-
A guide to safety data migrations
-
Patient voice survey
-
Patient Voice Survey - Decentralised and Hybrid Trials
-
Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
-
Using longitudinal qualitative research to capture the patient voice
-
Agile Clinical Monitoring
-
Regulatory Intelligence
-
An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
-
Using innovative tools and lean writing processes to accelerate regulatory document writing
-
Current overview of data sharing within clinical trial transparency
-
Global Agency Meetings: A collaborative approach to drug development
-
Keeping the end in mind: key considerations for creating plain language summaries
-
Navigating orphan drug development from early phase to marketing authorisation
-
Procedural and regulatory know-how for China biotechs in the EU
-
RACE for Children Act
-
Early engagement and regulatory considerations for biotech
-
Regulatory Intelligence Newsletter
-
Requirements & strategy considerations within clinical trial transparency
-
Spotlight on regulatory reforms in China
-
Demystifying EU CTR, MDR and IVDR
-
Transfer of marketing authorisation
-
An innovative approach to rare disease clinical development
-
Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
-
Glycomics
- Infectious Diseases
- NASH
- Oncology
- Paediatrics
-
Respiratory
-
Rare and orphan diseases
-
Advanced therapies for rare diseases
-
Cross-border enrollment of rare disease patients
-
Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
-
Diversity, equity and inclusion in rare disease clinical trials
-
Identify and mitigate risks to rare disease clinical programmes
-
Leveraging historical data for use in rare disease trials
-
Natural history studies to improve drug development in rare diseases
-
Patient Centricity in Orphan Drug Development
-
The key to remarkable rare disease registries
-
Therapeutic spotlight: Precision medicine considerations in rare diseases
-
Advanced therapies for rare diseases
-
Transforming Trials
-
Accelerating biotech innovation from discovery to commercialisation
-
Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
-
Linguistic validation of Clinical Outcomes Assessments
-
Optimising biotech funding
- Adaptive clinical trials
-
Best practices to increase engagement with medical and scientific poster content
-
Decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
Decentralised and Hybrid clinical trials
-
Practical considerations in transitioning to hybrid or decentralised clinical trials
-
Navigating the regulatory labyrinth of technology in decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
eCOA implementation
- Blended solutions insights
-
Implications of COVID-19 on statistical design and analyses of clinical studies
-
Improving pharma R&D efficiency
-
Increasing Complexity and Declining ROI in Drug Development
-
Innovation in Clinical Trial Methodologies
- Partnership insights
-
Risk Based Quality Management
-
Transforming the R&D Model to Sustain Growth
-
Accelerating biotech innovation from discovery to commercialisation
-
Value Based Healthcare
-
Strategies for commercialising oncology treatments for young adults
-
US payers and PROs
-
Accelerated early clinical manufacturing
-
Cardiovascular Medical Devices
-
CMS Part D Price Negotiations: Is your drug on the list?
-
COVID-19 navigating global market access
-
Ensuring scientific rigor in external control arms
-
Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
-
Global Outcomes Benchmarking
-
Health technology assessment
-
Perspectives from US payers
-
ICER’s impact on payer decision making
-
Making Sense of the Biosimilars Market
-
Medical communications in early phase product development
-
Navigating the Challenges and Opportunities of Value Based Healthcare
-
Payer Reliance on ICER and Perceptions on Value Based Pricing
-
Payers Perspectives on Digital Therapeutics
-
Precision Medicine
-
RWE Generation Cross Sectional Studies and Medical Chart Review
-
Survey results: How to engage healthcare decision-makers
-
The affordability hurdle for gene therapies
-
The Role of ICER as an HTA Organisation
-
Strategies for commercialising oncology treatments for young adults
-
Blog
-
Videos
-
Webinar Channel