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.

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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and legal jurisdictions across countries for decentralised clinical trials, including a summary of the recent FDA draft guidance on the use of digital health technology.

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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.

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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?

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Biopharma perspective: The promise of decentralised models and diversity 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 diversity 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.

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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.

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Paediatric clinical trials

How decentralising clinical trials will give the patient and their parents the support they need while also increasing equity. 

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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.

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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.

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Realising the benefits of in-home services

Find out how these services are increasing patient recruitment and retention:

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.

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Decentralised and hybrid trials media contributions

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.

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