Non-invasive testing could transform the management of metabolic liver disease and help shape the future of MASH clinical development. This article in SelectScience® explores the evolving NIT landscape, emerging regulat...
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How digital health technologies are reshaping clinical development
Digital health technologies are rapidly becoming essential to clinical trial strategies as regulators and sponsors embrace them to streamline operations, reduce patient burden, and generate higher‑quality real‑world data.
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Mind the gap: The need for gender-specific outcome measurement
Women experience significantly more years of poor health than men due to delayed diagnoses and mischaracterized symptoms, despite living longer on average. This health disparity is rooted in systemic gaps in medical research and clinical trial design, particularly in how health outcomes are measured through Clinical Outcome Assessments (COAs).
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Talking the talk
At ICON ensuring scientifically representative participation is not a stand-alone initiative, it’s embedded into every trial we support, shaping smarter, faster, higher-quality research. We start with the patient’s voice.
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Clinical strategies to optimize software as a medical device to treat mental health
Every clinical trial has challenges, but trials researching SaMD use to treat mental health disorders have unique ethical, regulatory and technical ones. In this Applied Clinical Trials article ICON’s Devin Ridgley and JoAnne Bronikowski explore the implications of a vulnerable patient population and new technology.
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ICON discusses how AI is changing clinical trial recruitment and diversity
Kathleen Mandziuk, Vice President of eClinical Development & Delivery, offers insights on the persistent challenges of patient recruitment, the revolutionary role of AI and digital tools, and the critical importance of diversity and inclusion.
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AI-powered precision measures: A golden opportunity for clinical research
As the cost of developing new therapies continues to rise, pharma executives must turn to technologies that drive better insights into de-risked investments and produce operational efficiencies. AI-powered digital measures are being developed and validated to better define disease, patients, and drug efficacy.
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Outcome measures: Patients beyond endpoints
The evolving regulatory requirement to put patients at the centre of the drug development process – patient-centric from end to end – means pharmaceutical sponsors must design clinical trials with patient-centred outcomes in mind.
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The future of RWD and RWE in healthcare decision-making: Applications of novel real-world data collection methods for healthcare decision-making
Read insights from Jennifer Eriksson, Divisional Principal, on the use of real-world evidence and real-world data to inform healthcare decision-making and provide patients with rapid access to innovative healthcare technology.
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Validating COAs: Key steps for accurate and reliable clinical trial data
With the increasing adoption of COAs, the importance of standardization across training, collection, and implementation to ensure high quality and consistent data collection has become apparent in recent decades.
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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.