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.
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and legal jurisdictions across countries for decentralised clinical trials, including a summary of the recent FDA draft guidance on the use of digital health technology.
Read the whitepaperA 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.
Read the blogPractical 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?
Read the whitepaperBiopharma 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.
Read the summary reportPatient 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.
Read the survey resultsPaediatric clinical trials
How decentralising clinical trials will give the patient and their parents the support they need while also increasing equity.
Read the articleAdvancing 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.
Read the whitepaperAgile 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.
Read the whitepaperRealising 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
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
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.
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.
Receive new insightsDecentralised and hybrid trials media contributions
Regulatory considerations in technology for decentralised clinical trials – Navigating evolving regulations
This article in the Journal of mHealth explores the guidance regulators have provided for diversity and inclusion in clinical trials, privacy considerations and endpoint selection.
Transforming Clinical Trials in a rapidly shifting landscape
Ute Berger, President, Development & Commercialisation Solutions outlines how ICON is transforming clinical trials in a rapidly shifting landscape in the Executive Interview in Drug Development & Delivery.
Trial blazing
Harpreet Gill, Vice President, Decentralised Clinical Trials at ICON reflects on the progress that has been made in decentralised and hybrid clinical trials in the last number of years in this article in PharmaTimes.
Boon and bane: dodging participant burden in decentralised clinical trials
As DCT adoption increases, Harpreet Gill looks at how sponsors and CROs must mind the risk of adding patient burden while designing decentralised trials.
Providing support throughout the patient journey
Concierge services are critical to helping patients navigate technology and other logistics in a decentralised clinical trial. Laney Preheim outlines how they can best be implemented.
Identifying integrated digital platforms designed for a decentralised future
Matt Harrington explores how the use of digital platforms and associated services can contribute to more adaptable, accessible and efficient clinical trials.
Decentralised clinical trials: mapping patient pathways with a focus on patient-centricity
Emily Mitchell discusses the importance of considering the target patient population when designing and deploying a decentralised clinical trial.
Evolution of clinical trial data calls for evolved response
Emily Mitchell and Kathleen Mandziuk discuss how study data has progressed in recent years and how trial teams can keep up effectively with proper data management.
JPM 2022: Decentralised trials, broader service offerings and novel drugs key trends in the CRO space
A snapshot from the J.P. Morgan Healthcare Conference 2022.
Capture, curate, consume: The three Cs of managing data in decentralised and hybrid clinical trials
Emily Mitchell and Christina Dinger run through some of the most important elements of collating and organising data during clinical trials.
Video series: The 3 "Cs" of the data journey
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.
Ensuring better patient outcomes through decentralised trials
The research industry has changed in the past year, and decentralised models are helping to improve patient outcomes and bring treatments to market faster (page 12).
eBook: Digital acceleration in clinical trials
Digital health has been a hot topic for many years, but it has taken the pandemic to really highlight its value across many areas of the pharma and biotech industries.
Decentralised, hybrid or traditional
Choosing the best option for your clinical trial.
Wearables in virtual clinical trials
Wearables are improving the clinical trial experience for patients and satisfying the need to collect data for real-world use studies.
Pfizer COVID vaccine trial proved remote monitoring and other innovations work
Starting clinical trials in weeks, as opposed to months, should be possible post-pandemic.
Bringing the trial to the patient
Reducing the burden that clinical trial participation places on patients can help to keep patients engaged in clinical research.
Mapping the patient journey and minding the gap
Seven steps to closing the gap between rhetoric and reality in patient-centricity.
Patient centricity
Exploring the patient perspective from different angles.
Thwarting cyber attacks
Steps to implement security into mHealth development.
The power of patients
Patient engagement is permeating all spheres of the healthcare ecosystem.
Decentralising research
Revolutionising clinical trials with wearables and digital endpoints.
Listening to the patient for better outcomes
Project teams need to be challenged constantly to justify the study procedures and eligibility criteria they are proposing.
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.
Read more about ICON's services