Clinical trials during COVID-19
Keeping your trial on track in an evolving environment.
Adapting operations to changing conditions
ICON has adapted its services to support sponsors during this time; offering remote monitoring where on-site visits were not permitted, providing additional support to get IMP to patients and pre-recording investigator meetings because of travel restrictions. Find out more about services to minimise disruption below.
COVID-19 vaccines: Post-authorisation safety surveillance
This whitepaper explores the multifaceted challenges of COVID-19 post-authorisation safety surveillance studies and how business intelligence tools can benefit these efforts.
Whitepaper: Implications of COVID-19 on statistical design and analyses of clinical studies
The COVID-19 pandemic presented a serious disruption in the conduct of clinical trials. In this whitepaper we discuss the challenges and risks to the statistical integrity of data as a result of these challenging conditions.
Whitepaper: Mitigating the impact of COVID-19 on cardiovascular trials
This whitepaper outlines measures that can be implemented in ongoing trials assessing cardiovascular-directed therapies to ensure the safety of participants, maximise retention and maintain trial integrity.
Integrated Solution - COVID-19
Driven by regulatory guidance
ICON has developed an integrated solution that deploys functional services driven by overarching COVID-19 regulatory guidance. No two studies are the same so our operational teams are ready to work with you to review study-specific plans and adopt the services needed to reduce disruption to trial timelines and stay compliant.
Contact us today to discuss the challenges and deploy the solutions.
Related factsheet: Keeping your trial on track during COVID-19.
Webinar recording: Keeping your trial on track
In this webinar industry experts present regulatory and operational insights on how to be proactive to protect patient safety and minimise disruption. Recent case studies show how creative thinking and collaboration can overcome challenges.
Regulatory audit & guidance
ICON regulatory consultants work to provide global strategic and operational guidance on regulatory updates to support customers' clinical development programmes. They can help you navigate the evolving developments during COVID-19 including; variations in regulatory guidelines on clinical trial conduct, pharmaceutical export restrictions, and expanded compassionate access for COVID-19 related compounds.
Download: the latest issue of our Regulatory Intelligence Newsletter. Subscribe to ensure you continue to receive each month’s issue.
Webinar: In-home clinical visits
In this webinar industry experts provide insight on planning and execution of In-home visits during COVID-19 and beyond, patient populations and study type considerations and current regulatory guidance.
Download our factsheet to find our how using these services can minimise disruption during COVID-19.
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COVID-19 impact on Health Technology Assessments (HTA) & reimbursement requirements
How will the changes brought about by the pandemic impact your existing pipeline of products? Will you need to adjust your existing HEOR evidence planning and timetables? Are there steps you can take to ensure that patients and providers will still have timely access?
Get insights and recommendations on navigating global market access requirements in this dynamic environment.
Using historical control data as an alternative
As patients face shelter-at-home restrictions and quarantine, and sites redirect efforts to treat COVID-19 patients, it can be faster, more economical and more patient-centric to utilize historical real world data as a control option for some studies, particularly in rare diseases. This approach can help to maximize patients on active therapy and reduce the total trial population sample size. It can also be more appealing to patients and physicians, by reducing the need for patients to travel to sites.
Protecting the patient and data integrity
Safety Reporting: The COVID-19 pandemic is intensifying an already complex regulatory environment and making compliant safety reporting more difficult. Find out how regulatory intelligence, pharmacovigilance expertise and automation can reduce risk and ensure compliance at this time.
Related Factsheet: Safety Reporting during COVID-19
Related blog: The impact of COVID-19 on pharmacovigilance
Data Monitoring Committees: The FDA and EMA have both acknowledged that Data Monitoring Committees (DMC) may have a part to play in overcoming some of the challenges that we are seeing in this evolving environment. A well-organised and properly constructed DMC will help to ensure patient safety, protect data integrity as well as support appropriate analysis and interpretation of the trial data.
Ensuring continuity of IP to patients
In the current environment patient visits may be re-scheduled and protocols may need to be amended. Now is the time to check if your IRT system needs adjustment to ensure continuity of IP to patients. Our IRT and Clinical Supply Management team are ready to advise you on strategies to mitigate risks and maintain flow of clinical supplies.
Download our factsheet to find out more about being proactive to reduce risk in clinical supply flow.
Maintaining patient contact
Our Direct to Patient Contact solutions support patients or their caregivers in studies and disease management programs and can enable you to connect with patients during the pandemic. Built on our global clinical outcomes expertise, real world evidence experience and clinical cross-cultural language services expertise, we offer multi-faceted contact methods including email, SMS, phone, letter and in-app alerts to:
- Facilitate the collection of patient reported data (COAs, QoL, drug/resources utilisation, safety outcomes)
- Enhance patient engagement through flexible, customised approach based on patient preference
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Pre-recorded investigator meetings
Travel restrictions to protect healthcare professionals has understandably resulted in the cancellation of investigator meetings.
FIRECREST digital solutions provide the option to pre-record meeting content and deliver remote site training to maintain reporting for compliance.
Overview of COVID-19
A video explaining the origin, identification and symptoms associated with this coronavirus
The cause of the disease was later identified as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) a novel coronavirus belonging to the same family as SARS-CoV and MERS-CoV. Human to human transmission is thought to happen largely through close contact with infected individuals particularly through exposure to respiratory droplets or airborne aerosols.
Remote monitoring
ICON have the processes, technology and experience to be able to shift to a remote monitoring model where regulation permits. In late phase studies our Site Management Associate (SMA) model is designed specifically for managing late phase studies, in multiple languages and cultures, to provide continuous site support throughout the world. This focused, one-on-one approach is designed to improve data collection, ensure high quality data, and enhance site and patient engagement, while significantly reducing late-phase study costs.
COVID-19 blogs and media articles
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Media article: Has the pandemic enabled us to accelerate the pace of drug development?
Nuala Murphy contributes to this Marvellous Medicine BBC4 podcast about accelerating the pace of drug development due to the pandemic.
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Media article: A trusted partner for clinical development
ICON CEO Steve Cutler chats with Newsweek, on ICON’s role in the development of much needed medicines. The interview (page 12 of PDF) is part of a special report on Ireland.
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Media article: Smart people: Dr. Steve Cutler
PharmaTimes talks to Dr Steve Cutler, CEO at ICON plc, about the impact of the COVID pandemic and challenges of running large-scale vaccine trials.
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Blog: Looking back and looking ahead: Trends in HEOR
In-person research became impossible due to the pandemic, and forced us to re-examine how patient's voices were being captured. In 2021 we continue to build on what we learned.
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Blog: Navigating complexity of cell therapy manufacturing during the COVID-19 pandemic
Over the past year, the COVID-19 pandemic significantly disrupted clinical research across the lifecycle including recruitment challenges, protocol amendments and delayed market entry.
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Media article: Global collaboration: Irish company ICON on scaling up COVID-19 vaccine trials
An interview in which Steve Cutler gives a short overview of ICON and describes the company’s role in the Pfizer/BioNTech trial, explaining how the FDA played a critical role in expediting regulatory approvals.
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Media article: The effect of Covid-19 solutions on the clinical trials process
Shelley McLendon, VP of Project Management, Vaccines and Infectious Diseases, outlines best practices that can keep trials running at optimal speed and efficiency, and the benefits of adopting a strategic partnership.
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Media article: A challenge of pandemic proportions
ICON CEO Steve Cutler, discusses running the Pfizer / BioNTech vaccine trial, and how it proved the value of partnership, and the key role of technology.
