Remote, on-site and centralised monitoring - getting the mix right for better outcomes
Travel restrictions and social distancing measures due to COVID-19 significantly disrupted clinical trials, with some drug development companies delaying or postponing their studies following the initial outbreak. Although studies began to reopen mid-year, one analysis by Medidata showed that the enrollment of new participants in trials remains 30 percent below pre-pandemic levels. This unprecedented event has drug developers assessing the way that trials are conducted and accelerating the use of alternative designs and hybrid models to improve study management.
Even as the pandemic subsides, the use of remote management to increase efficiency is likely to continue to grow as it is adopted into post-COVID clinical trial designs. The agility to adopt the right clinical monitoring has been important to keep trials on track in the challenging environment of a pandemic. COVID-19 has accelerated the thinking on clinical monitoring permanently and may forever change the approach to future clinical trials.
Pre-pandemic trial designs
Prior to the COVID-19 pandemic, there was an over reliance for Clinical Research Associates (CRAs) to be on site to ensure a study was monitored. This may have been partly due to a very conservative approach to the risk analysis conducted at the outset of the study. On-site monitoring, the more traditional approach, was used in the vast majority of studies and involved the CRA traveling to an investigational site to review and discuss the study conduct; to confirm that patient safety and welfare was protected at the site including the informed consent process, to review storage conditions, allocations and accountability of the investigational drug, to perform source data verification (SDV) and perform source data review (SDR).
COVID-19 accelerating the shift to remote monitoring
In response to the restrictions resulting from COVID-19, in March 2020 the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency gave permission to start considering optimising the use of “central and remote monitoring programmes to maintain oversight of clinical sites.” Since that point, the industry increased the amount of remote monitoring with oversight from centralised monitoring. The ability to review trial conduct, real-time data and trend analysis while off-site allows CRAs to focus more on process issues while on-site.
The future is agile
Implementing a robust and flexible monitoring strategy can increase efficiency and cost-effectiveness when built into study design at an early stage. For example, assuming a CRA can get full access to the source notes, the cost per off-site monitoring visit could be reduced by approximately 40 percent when accounting for both travel costs and time spent traveling.
The COVID-19 pandemic has enabled drug developers to embrace the potential of remote monitoring in a way that is likely to carry on into future studies. The use of a well-executed hybrid monitoring strategy is the way forward for companies to remain agile adapting to therapeutic, regional and patient considerations.
For more information on how ICON can help your trial shift to a remote monitoring model, read our whitepaper “Agile Clinical Monitoring: The flexibility to keep your trials on track.”
In this section
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Digital Disruption
- AI and clinical trials
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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
- Remote Patient Monitoring
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Personalising Digital Health
- Real World Data
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The triad of trust: Navigating real-world healthcare data integration
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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
- Diversity and inclusion in clinical trials
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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
- EU Clinical Trials Regulation
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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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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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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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Spotlight on regulatory reforms in China
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Demystifying EU CTR, MDR and IVDR
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Transfer of marketing authorisation
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An innovative approach to rare disease clinical development
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Therapeutics insights
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Glycomics
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Respiratory
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Rare and orphan diseases
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Advanced therapies for rare diseases
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Cross-border enrollment of rare disease patients
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Diversity, equity and inclusion in rare disease clinical trials
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Identify and mitigate risks to rare disease clinical programmes
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Leveraging historical data for use in rare disease trials
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Natural history studies to improve drug development in rare diseases
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Patient Centricity in Orphan Drug Development
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The key to remarkable rare disease registries
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Therapeutic spotlight: Precision medicine considerations in rare diseases
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Advanced therapies for rare diseases
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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Linguistic validation of Clinical Outcomes Assessments
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Optimising biotech funding
- Adaptive clinical trials
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Best practices to increase engagement with medical and scientific poster content
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Decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Navigating the regulatory labyrinth of technology in decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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eCOA implementation
- Blended solutions insights
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Implications of COVID-19 on statistical design and analyses of clinical studies
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Improving pharma R&D efficiency
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Increasing Complexity and Declining ROI in Drug Development
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Innovation in Clinical Trial Methodologies
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Risk Based Quality Management
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Transforming the R&D Model to Sustain Growth
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Accelerating biotech innovation from discovery to commercialisation
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Value Based Healthcare
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Strategies for commercialising oncology treatments for young adults
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US payers and PROs
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Accelerated early clinical manufacturing
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Cardiovascular Medical Devices
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CMS Part D Price Negotiations: Is your drug on the list?
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COVID-19 navigating global market access
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Ensuring scientific rigor in external control arms
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Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
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Global Outcomes Benchmarking
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Health technology assessment
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Perspectives from US payers
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ICER’s impact on payer decision making
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Making Sense of the Biosimilars Market
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Medical communications in early phase product development
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Navigating the Challenges and Opportunities of Value Based Healthcare
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Payer Reliance on ICER and Perceptions on Value Based Pricing
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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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RWE Generation Cross Sectional Studies and Medical Chart Review
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Survey results: How to engage healthcare decision-makers
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The affordability hurdle for gene therapies
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The Role of ICER as an HTA Organisation
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Strategies for commercialising oncology treatments for young adults
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