mHealth and Wearables
Leveraging mobile technology and connected devices in clinical trials
It's time to accelerate remote patient monitoring adoption
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, making it easier for patients to participate, ensuring participants and care providers remain connected wherever they are located and improving recruitment through greater access to diverse patient populations.
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.
Accelerating clinical development through digital health technologies
This whitepaper presents a comprehensive roadmap for adopting DHTs in clinical trials, from selecting the right digital measures to implementing them at scale. Read this whitepaper to learn the DHT strategies that reduce trial costs, accelerate timelines, and help bring patient-centred treatments to market.
Outcome measures: Prioritising patient-centred research for regulatory approval
The growing sophistication and popular use of digital health technologies (DHTs) provide ever-increasing opportunities to capture nuanced patient data. This whitepaper presents a framework combining traditional COAs and DHTs to create a holistic view of treatment impact.
Wearables and digital endpoint strategy and validation
In this whitepaper we discuss a framework for integrating Digital Health Technologies (DHTs), from building a case for the broader adoption, to demonstrating their future potential and impact on R&D. We provide an end-to-end framework to selecting and validating devices and endpoints and provide checklists for device selection and data strategy
Personalising Digital Health
DHTs are increasing the efficacy of therapies in the real world through continuous monitoring, telemedicine and prescription digital therapeutics to help patients better manage their conditions, supporting patient retention and engagement on clinical trials. AI and machine learning are allowing for richer data generation and collection, driving insights for making better drug and medical device development decisions sooner.
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Closing the evidence gap
Digital health technologies and drug reimbursement
As digital health technologies (DHTs) or "wearables" continue to advance, there are key considerations for drug sponsors to consider to ensure that the data generated by DHTs are acceptable to payers.
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Wearables webinar recordings
Digital endpoint strategy and validation
The COVID-19 pandemic has heightened interest in mHealth and mobile technology to capture patient insights outside of the traditional clinical setting.
Best practices for implementing a successful digital trial
91黑料 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.
eCOA - insights into equivalence testing methodology and implications for BYOD
In this webinar, we review the accumulating evidence to support measurement equivalence of instruments when migrated to ePRO.
Smartphone sensors to measure novel health outcomes
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.
Activity monitoring setting standards for clinical research
With the introduction of sensors, wearables and apps we can fullly engage patients in real time to increase the quality of data.
Media contributions on wearables, sensors and remote monitoring
The value of measuring sleep and activity in Alzheimer's disease trials.
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.
Case studies on wearables, sensors and remote monitoring
Leveraging BYOD, wearables and shareables in Real World Evidence studies
Approaches to leveraging mobile, wearable and shareable technology in observational research
mHealth and wearables blogs
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Blog: Benefits of implementing a unified patient experience in clinical trials
Inconsistent patient engagement has been a leading challenge in clinical trials. Learn how to overcome this challenge and maximise your trial's potential today.
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Blog: Making the move to virtual clinical trials late-phase research
Late phase research, once the exception, is becoming the rule. Some post marketing evidence needs can be met with virtual studies, DtP and cyber studies.
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Blog: mHealth devices allow for better treatments and clinical outcomes
Benefits include better, more personalised, treatment and improved clinical outcomes, with fewer clinic visits and greater independence for patients.
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Blog: Real-time monitoring of the digital patient
Direct to patient strategies and crafting patient centric trials are of increasing interest in drug development trials.
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Blog: Measuring activity in COPD and other less active populations
While activity monitors have been used in clinical trials, some researchers consider a number of perceived barriers limiting their use.
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Blog: Measuring the impact of physical activity and exercise on Alzheimer’s disease
There is considerable and increasing body of published research investigating the impact of physical activity and exercise has on Alzheimer’s disease.
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Blog: Fewer Third-Party Device ISO Report Auditors Authorised Under MDSAP in U.S. and Canada
New rules from the FDA and Health Canada have restricted the number of third-party organisations authorised to audit ISO reports
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Blog: Dirty data: How to manage data from wearables in clinical trials
How to manage data from wearables in clinical trials — from overcoming regulatory issues to handling challenges associated with dirty data.
Real World Data insights
91黑料'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.
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