The COVID-19 pandemic has been a catalyst for change in cancer research, forcing a shift towards remote monitoring, virtual arms and other uses of digital tools as global lockdowns reduce the ability of patients to go to clinics.
While the pandemic has certainly brought to the fore discussions on how we operationalise trials, at this point it is unlikely to have any impact on trial design or endpoint selection, but there is very healthy discussion going on about running trials differently, right from the patient experience through to how we manage data.
The permanence of these changes will be contingent on a number of things and there will always be a mixed model in oncology. Although there is a benefit to the patient if they have to go into the clinic less, we need to make sure that there is no compromising of patient safety. The complex requirements of oncology studies – radiology, scans, imaging etc. cannot be done in an individual’s living room. Neither can earlier phase studies that require hospitalisation for PK sampling. Hospitals will have to be amenable to having other bodies being part of the assessments and conduct of clinical trials, both from an economic and logistics point of view.
Realistically, the crisis is not going to completely turn over oncology studies to become completely different from how they are now. Nevertheless, ICON is prepared for increasing virtualisation in trials. For example, last year we acquired Symphony Clinical Research, a provider of in-home and alternate site services. We also work with a number of telemedicine platforms, and we have people within our group devoted to the virtualisation of trials. To speak to one of our experts, please contact us.
This blog is an edited version of “Adapting for the future of oncology” which appeared in PharmaPhorum's 'Future of Oncology 2020' magazine in July 2020. To view the full article, please visit https://deep-dive.pharmaphorum.com/magazine/future-of-oncology-2020/adapting-future-oncology-icon/ .
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Digital Disruption
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Clinical strategies to optimise SaMD for treating mental health
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Digital Disruption: Surveying the industry's evolving landscape
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
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Digital disruption in biopharma
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Disruptive Innovation
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Personalising Digital Health
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The triad of trust: Navigating real-world healthcare data integration
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Clinical strategies to optimise SaMD for treating mental health
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Patient Centricity
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
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Developing Nurse-Centric Medical Communications
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Agile Clinical Monitoring
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Regulatory Intelligence
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An innovative approach to rare disease clinical development
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Regulatory Intelligence Newsletter
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Requirements & strategy considerations within clinical trial transparency
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Transfer of marketing authorisation
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Improving pharma R&D efficiency
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