Leveraging mobile technology and connected devices in clinical trials
Navigating the shift from traditional trial models to agile, patient-centric processes driven by digital health technologies.
Incorporating digital health technologies into clinical trial designs has the potential to address many clinical trial challenges, including patient retention and engagement.
Remote patient monitoring makes it easier for patients to participate and improves recruitment through greater access to diverse patient populations.
The use and management of data from connected devices (wearables, sensors, smartphones, laptops, tablets), mobile platforms, and telemedicine, offers effective clinical care while protecting the patient with ongoing monitoring, ensuring participants and care providers remain connected wherever they are located.
Wearable devices and sensors also enable the collection of richer data and insights to enhance understanding of the effects of treatment and objective measures of intervention effects both in-clinic and in remote free-living settings.
Health Harmony simplifies planning and deploying remote care management for the clinician, participant, and family caregiver. Connecting in real-time from the comfort of their home, participants can experience an even wider and more efficient network of care. With apps in their hands, participants can track signs, symptoms, and conduct self-reporting and if symptoms escalate, remote monitoring and support from a healthcare professional can provide early intervention.
Health Harmony gives patients more control and better access to personalised healthcare, right from their own devices and on their own schedule. Easy-to-use devices, with minimal set-up, makes engaging patients easier by integrating care into patients’ daily lives. Patients get full access to a powerful platform that offers interactive health sessions, educational content, and video conferencing.
However remote patient monitoring requires a robust strategy in data management, including digital endpoint validation and interpretation.
Our ICON Insights will help you to understand and successfully address the complexities of implementation of wearable devices in trial design, execution and reporting.
Although mHealth devices and sensors are continuing to evolve, and it is now possible to capture a vast array of physiological data, the operationalization of digital trial is not without challenges.
The COVID-19 pandemic has heightened interest in mHealth and mobile technology to capture patient insights outside of the traditional clinical setting.
ICON and Intel explore industry concerns about implementation of this technology in a clinical trial, including patient acceptance, device suitability, data complexity and insight generation, operationalisation, privacy and security issues, and regulatory acceptance.
In this webinar, we review the accumulating evidence to support measurement equivalence of instruments when migrated to ePRO.
This webinar explores the novel uses of smartphone sensor measurement in the areas of health, wellness and clinical research and appraises the promise of these approaches in clinical trials.
With the introduction of sensors, wearables and apps we can fullly engage patients in real time to increase the quality of data.
In this webinar learn more about payer requirements for additional evidence, wearables as a potential solution, payer preparations for digital technologies, and more.
In this article in Pharmaceutical Market Europe, Dr Peter Schueler and Dr Isaac R Rodriguez Chavez outline the role of digital health technology tools in supporting medical adherence.
This three part video series examines some of the factors that should be considered to ensure that clinical trial data captured via wearable devices, is monitored expeditiously and effectively.
Robust assessments based on digital data are a means of reducing the uncertainty that HTA bodies and payers face in making decisions around advanced therapy medicinal products.
Wearables are improving the clinical trial experience for patients and satisfying the need to collect data for real-world use studies.
Developing a protocol that incorporates data collection via mHealth technologies requires a comprehensive solution that has a strong patient engagement element and a robust digital framework.
To understand these large datasets, AI and machine learning are necessary to automate analyses.
Wearables are purpose-built to engage users, with optimized interfaces, easy-to-use screens, appealing companion apps and easy-to-interpret dashboards.
New ways to collect data and transforming clinical operations.
Maximising AI’s involvement in pharma development is to utilise its ability to draw distinctions and correlations, which would otherwise elude human observation.
The foundation of healthcare is shifting from a provider-based to a patient-centric, or value-based, model.
Sleep quality and quantity have clinical relevance in Alzheimer's disease. Review the use of wearables in Alzheimer’s disease to provide objective measures of sleep and activity patterns that are not subject to patient recall bias.
ICON’s wearables and patient outcomes teams were able to objectively measure cough using patient-centric, novel technologies.
Generating respiratory disease specific biomarkers using advanced analytics.
ICON uses AI machine learning algorithms to develop new digital biomarkers from raw accelerometer data.
ICON’s eCOA team and wearables consultants design, implement and manage a technology solution for a global trial across nine countries amongst patients suffering from a neurological disorder.
Approaches to leveraging mobile, wearable and shareable technology in observational research
How to best incorporate digital endpoints at every stage of clinical research?
How COVID-19 altered clinical trials forever and what’s next?
An end-to-end approach to managing wearable devices through clinical development.
An end-to-end solution is required to run a successful digital trial.
The REACHES study considered how assessments that are traditionally conducted at a clinic visit.
Direct to patient strategies and crafting patient centric trials are of increasing interest in drug development trials.
Patients increasingly act like consumers, expecting to control decisions about their care and to receive individualised products and services
Accelerometers can capture significant quantities of raw data, potentially containing patterns
which, could quantify specific motor movements.
ICON’s Innovation lab have begun to develop prototype solutions that could be used in clinic to make objective assessments of movement and mobility.
Measuring treatment-related changes in sedentary behaviour using wearable technology.
While activity monitors have been used in clinical trials, some researchers consider a number of perceived barriers limiting their use.
How to manage data from wearables in clinical trials — from overcoming regulatory issues to handling challenges associated with dirty data.
The more that can be done to encourage patients to participate in clinical trials, the faster new medicines and devices become available.
ICON's real world data (RWD) continues to drive healthcare and research discussions and decisions. Stay up to date with the latest information that regulators, payers and providers demand.Read more