Participant-centric study design has advanced, but site-centric execution has not kept pace. In the Journal for Clinical Studies, Brian Mallon examines how unclear expectations, administrative burden and contract delays ...
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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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Human-enabled AI driving enhancements in clinical trial site selection
In this piece from Clinical Trial Vanguard, Travis Caudill, Vice President, Feasibility, Site Identification & Clinical Informatics explores the improvements in site selection that human-enabled AI is delivering.
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Embedded and agile – The next phase of the DCT evolution
In this article, Darlene Ellenor Director of Project Operations, Decentralized Clinical Trials Operations 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. As DCT evolves, an embedded approach backed by the right processes and tools will maximize the benefits that DCTs bring to clinical research.
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Central to the mission
In this article from Pharmaceutical Executive, Harpreet Gill, VP of Real World Solutions - Project Management, discusses the progress and challenges in advancing data-driven tools and approaches in decentralised clinical trials.
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Centred on decentralised trials: Q&A with Harpreet Gill
In this article on Pharmaceutical Executive’s website, Harpreet Gill discusses how DCTs can transform clinical trials and improve the patient experience.
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Patient-first technology development increasing patient centricity
This article by Carrye Nibblelink, Executive Director, Decentralised Clinical Trial Solutions in the Journal of mHealth explores how the ICON Digital Platform engages patients throughout their clinical trial journey.
Copyright 2023 The Journal of mHealth (Simidics Ltd)
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Regulatory considerations in technology for decentralised clinical trials
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, and is authored by Jo Hulbert, Executive Director, Global Regulatory Clinical Services with contributions from Arwa Shurrab, Senior Director, Global Regulatory Affairs and Priti Prasad, Senior Manager, Global Regulatory Affairs.
Copyright 2023 The Journal of mHealth (Simedics Ltd)
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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.
January/February PharmaTimes
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Boon and bane: dodging participant burden in decentralised clinical trials
As DCT adoption increases, Harpreet Gill, Head of Decentralised Clinical Trial Solutions at ICON contributes to this piece in Clinical Trials Arena which looks at how sponsors and CROs must mind the risk of adding patient burden while designing decentralised trials.
Verdict Media Limited 2022
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Expert Q&A: The impact of the clinical trial liaison function
Expert Q&A: The impact of the clinical trial liaison function
The clinical trial liaison (CTL) function was first introduced in 2014 to help sponsors differentiate themselves from the competition by driving recruitment success in clinical trials.
FirstWord spoke with Elizabeth Pash, Senior Director of Global Site Engagement Operations at ICON, to find out exactly what this relatively new role involves, its value in developing and delivering optimal clinical trials and how it is set to evolve in future.
Summary points from the interview:
- In the competitive world of pharmaceutical research, sponsors can differentiate themselves by driving recruitment success in clinical trials.
- The CTL role was introduced in 2014 to bring doctorate-trained clinical research professionals into the clinical trial process to support site identification, activation and recruitment, ensuring optimal productivity of clinical trials.
- While CTLs and clinical research associates (CRAs) are both considered protocol experts and build relationships with sites, CTLs focus on the scientific aspects of a protocol rather than the eligibility criteria and schedule of assessments.
- At ICON, CTLs have contributed to a 20% boost in the targeted recruitment rate and helped approximately 70% of sites achieve their baseline recruitment goals. In the past five years, they have also helped sponsors bring nine new compounds to market and receive two new indication approvals for already-approved medications.
- As more clinical trials begin to incorporate more decentralised approaches, the need for roles like CTLs is set to steadily increase across the industry.
- Potential is increasing for CTLs to establish partnerships earlier with sponsors, supporting trial and protocol design, conducting targeted investigator interviews and applying the information in the early stages of clinical development.
[Subscription is required to view the entire interview]
