Decentralised clinical trials
Patient focused research for better outcomes
With the rising cost and time to bring new drugs to market and more recently the pandemic outbreak, the demand for decentralised and hybrid trials has risen. These alternative trial models can range in shape and form to include digital health technologies, in-home clinical visits and remote monitoring.
Decentralised clinical trials: Overcoming the challenges to drive economic value in clinical development
What will it take for sponsors to overcome the technological and operational challenges to embed decentralisation into their organisations and make it business as usual? To answer this and other questions, The Financial Times hosted a webinar and invited senior executives from Bayer, AbbVie and Biogen to discuss their experiences with DCTs, touching on the hurdles they have faced, their view of current regulatory guidance, and the impact on trial budgets.
Navigating the regulatory labyrinth of technology in decentralised clinical trials
This whitepaper discusses the varying regulatory and legal jurisdictions across countries for decentralised clinical trials, including a summary of the recent FDA draft guidance on the use of digital health technology.
A positive step for representation and inclusion in clinical trials – reflections on FDORA
The FDA’s new FDORA bill includes provisions intended to improve scientifically and clinically relevant representation in trial enrolment through decentralised clinical trials and associated digital health technologies.
Practical considerations in transitioning to hybrid or decentralised clinical trials
Everyone is talking about decentralised clinical trials. But how can we leverage what we learnt during 2020 and move forward in a more systematic way to deploy this approach with maximum efficiency and optimum results?
Biopharma perspective: The promise of decentralised models and representation in clinical trials
ICON invited senior biopharma executives to discuss how decentralised and hybrid clinical trial models can provide increased resilience and to share how their respective organisations are currently or likely to address representation and inclusion in clinical trials going forward. This summary report outlines how these executives see the opportunity in the developments of 2020, paving the way for continuous improvements into the future.
Patient insight - decentralised & hybrid clinical trials
Engaging patients more fully and making sure decentralised clinical trials are easing rather increasing burden is going to be crucial to using these models in the longer term. Early in 2021, ICON conducted a survey to compare it to one conducted in 2019 to see if the COVID-19 outbreak had changed the sentiment and increased interest in participating in clinical trials remotely.
Paediatric clinical trials
How decentralising clinical trials will give the patient and their parents the support they need while also increasing equity.
Advancing digital endpoints
Although mHealth devices and sensors are continuing to evolve, and it is now possible to capture a vast array of physiological data, the operationalisation of digital trials is not without challenges. Navigate the shift from traditional trial models to agile, patient-centric processes driven by digital health technologies.
Agile clinical monitoring
During COVID-19 the levels of remote monitoring increased due to site closures and safety reasons. Now is the time to learn from that experience and review whether a hybrid model of remote monitoring and centralised monitoring is the way forward for some trials. Learn best practices in analysing and assessing risk in clinical monitoring and how to remain agile adapting to environmental conditions and therapeutic focus.
Realising the benefits of in-home services
Find out how these services are increasing patient recruitment and retention:
mHealth & wearables
Understand how to implement wearable devices and harness digital endpoints in clinical trials:
- Webinar: The template for implementing a successful digital trial
- Factsheet: Wearables and digital endpoint validation
- Case study: Wearables and remote monitoring: Quantifying cough with sensor technology
- Case study: Conducting a trial in a community setting: The REACHES study
Decentralised and hybrid trials webinars and podcasts
Webinar: Financial Times - Decentralised Clinical Trials in Focus
The Financial Times in partnership with ICON, brought together senior leaders from Biogen, Bayer and AbbVie to discuss their most recent experience of decentralised clinical trials, where they see the issues and share the strategies and tactics they are exploring to deliver success.
Podcast: Patient diversity recruitment
Emily Mitchell and Mike Andino discuss the rising demand to address diversity in clinical trials and how decentralising clinical trials and tailoring patient strategies will improve results.
Podcast: Engaging investigators in decentralised clinical trials
Harpreet Gill and Ashmee Bharadia explore the importance of investigator buy-in to decentralised clinical trials and practical steps to enhance collaboration.
Webinar: Best and processes to build confidence in the value of in-home services
This webinar explores the challenges and concerns of key stakeholders regarding in-home services, and how to overcome them using tried and trusted methods.
Decentralised and hybrid trials blogs
Keeping up to date with the latest regulatory developments for decentralised clinical trials
This blog examines the crucial topic of regulating the use of DCTs, exploring what’s in place now and what sponsors need to consider as these methods continue to gain traction.
A positive step for diversity and inclusion in clinical trials – reflections on FDORA
The FDA’s new FDORA bill includes provisions intended to improve diversity in trial enrolment through decentralised clinical trials and associated digital health technologies.
Real-time monitoring of the digital patient in clinical trials
The collection of real-time data in a home setting can give sponsors and trial managers greater visibility and assurance around GCP and protocol compliance.
Wearables across phases
How to best incorporate digital endpoints at every stage of clinical research.
Wearables and digital endpoint generation
An end-to-end approach to managing wearable devices through clinical development.
Decentralised and hybrid trials videos
Receive more insights on decentralised & hybrid clinical trials from ICON
Please visit ICON's Preference Centre and select 'Decentralised & Hybrid Clinical Trials' under 'Patient Centricity' to receive new insights on decentralised & hybrid clinical trials.
Decentralised and hybrid trials meida contributions
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Media article: Obesity trial surge puts the focus back on decentralisation
Explore the evolving obesity clinical trials landscape and the role of decentralisation and new technologies in this recent CTA article.
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Media article: DCT Tracker: Charting the next chapter for decentralisation
More than four years after decentralisation became a necessity in the clinical trials space, the sector is still finding its way around decentralised clinical trials (DCTs). And like any other paradigm shift, the journey has taken several turns.
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Media article: Interview with Andy Coravos
In this article, Andy Coravos, founder of HumanFirst, recently acquired by ICON, shares insights on leveraging digital health technologies and wearables to manage chronic conditions.
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Media article: Current state of drug development, clinical trials and precision measures
This article provides an overview of a recent npj Nature publication, that proposes enough alignment exists between independent traditional COA and DHT libraries to build a single framework for researchers to identify and compare actively-collected versus passively-monitored tools for the same or similar measure.
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Media article: Making the most of biodata in remote studies
In this piece, Rosie Abbott explores how advances in technology have opened up many new opportunities and challenges in research, including the collection of biodata in remote studies. (see page 9)
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Media article: Embedded and agile – The next phase of the DCT evolution
This article highlights how DCTs are now considered a patient centric model for sponsors that want to enhance the patient and site experience and generate more robust data.
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Media article: Data integration frameworks key for embracing big data’s potential
Rick Rosenthal and Paula Fullman explain how to navigate the complexities and challenges of the evolving digital landscape of healthcare data.
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Media article: ICON acquires HumanFirst to boost support for digital tools in clinical trials
This article from STAT covers ICON’s acquisition of HumanFirst, a cloud-based technology company supporting precision measurement in clinical trials.
ICON's solutions in decentralised and hybrid clinical trials
Decentralised and hybrid trials bring a wide range of benefits to the patient and the sponsor. Find out more about the range of decentralised and hybrid trials services available from ICON.