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: The rise of precision outcome measures
Precision outcome measures are the means by which to evaluate a meaningful change on the exact outcome of interest, regardless of tool or instrument.
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Blog: Enhancing clinical trials in obesity by integrating COAs and DHTs
As obesity treatments evolve, traditional weight-centric endpoints are no longer enough. This blog examines how Clinical Outcome Assessments (COAs) and Digital Health Technologies (DHTs) are reshaping obesity clinical trials and aligning research with what truly matters to patients.
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Blog: Modern tools for cardiovascular studies
Cardiovascular disease is the leading global cause of death, driving urgent research efforts. CV studies are key to evaluating heart-related treatments and impacts. Digital health technologies (DHTs) now play a growing role, improving data capture and patient-centricity in CV research.
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Blog: How COAs and DHTs offer deep insights into patient experiences and treatment effects
A conversation with Sonia Bothorel, Managing Director, Mapi Research Trust and Outcome Measures Solutions.
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Blog: Why using COAs and DHTs together is the future of clinical research
Though both COAs and DHTs are tools used to evaluate a treatment’s impact, they often exist in separate spheres. We argue that combining these two approaches in the same study can help researchers gather better data and improve the likelihood of regulatory approval.
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Blog: Digital health: why evaluating human factors is essential
With the rapidly evolving technology, digital health is transforming healthcare, emerging as a promising solution to reduce rising healthcare costs and improve patient care.
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Blog: Digital health: managing cybersecurity risks
When developing a new digital health device, as well as maintaining an existing device, securing the device from cybersecurity attacks is critical.
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Blog: Utilising connected sensors to power diverse and equitable clinical trials
Our publication in Nature npj Digital Medicine outlines current evidence and a solution framework for diversity in research using digital health technologies.
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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