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Why and How is Clinical Monitoring Transforming at Speed – Are you ready for the future?
The global pandemic: a catalyst for long overdue changes in clinical trial monitoring?
Jun 02, 2021
The global pandemic created challenges the healthcare industry never could have imagined. However, it also opened the doors to innovation in trial conduct. For an industry that is cautious and modest in change, the pandemic accelerated the pace of innovation, adopting virtual technologies and digitization of processes in clinical research like never before.
One specific change is the adoption and rapid inclusion of remote and centralized monitoring and advanced analytics in lieu of more traditional on-site approaches. This change requires a level of expertise and experience that sponsors may not hold in-house and may consider use of a functional service provider, or FSP, to manage.
For more than a decade, regulatory bodies and other industry stakeholders have weighed in on the use of risk-based monitoring (RBM). The U.S. Food and Drug Administration and European Medicines Agency have provided guidance encouraging the use of centralized monitoring methods when appropriate.
Despite regulatory support, adoption of these models was slower than anticipated prior to the pandemic. However, we have witnessed tremendous advances in new clinical trial designs and technologies to mitigate against longstanding challenges to drug development.
Given lessons learned during the pandemic, sponsors may consider integrating technology and analytics across their portfolios moving forward, and how FSP experts may be able to help accomplish this.
Modernizing monitoring
Technology enablement is key to transforming trial monitoring in several ways, including automated key risk indicator (KRI) management, early signal detection across patient safety and eligibility, and fully auditable and traceable workflows to manage risks at the study, site and patient level.
If looking at modernizing monitoring in incremental levels, sponsors could see integration as:- Level 1: Delivering RBM through risk-based strategies and centralized monitoring where use of analytics and automated processes can reduce source verification of data and effort for clinical research associates (CRAs) normally associated with on-site monitoring visits.
- Level 2: Connecting RBM and decentralized trials (DCT) by utilizing integrated monitoring capabilities and emerging DCT technology framework to enable remote patient and site management while removing onsite-specific tasks, allowing for more time and focus for patient needs.
- Level 3: Using patient-generated data via remote monitoring data collection to further transform clinical monitoring and enhance direct-to-patient tools and processes.
IQVIA’s FSP tech-enabled capabilities and breadth of data integration and analytics services allow sponsors to build a successful journey mapping through these three levels of operating model transformation. Implementation of decentralized and direct-to-patient process elements is driving demonstrable benefits in meeting patient recruitment needs for clinical research. In addition, the use of artificial intelligence and machine learning (AI/ML) capabilities enable monitoring of safety trends across sites, participants, or regions to make needed changes quickly.
Integrated technologies
In order to make the shift to remotely-managed sites, sponsors must ensure needed information is available and accessible remotely. Key components to ensure data integration improves downstream processes and does not increase patient and site burdens, include: Trial design and process: simplified protocols and fit-for-purpose electronic data capture (EDC) design.- New technology: IQVIA uses a Central Data Repository or CDR to hold information from various trial stages through use of technologies, including IQVIA’s decentralized trial platform, connected devices, electronic consent (eConsent) and more.
Data-driven integrated processes: Enabling integration of data-driven processes across trial activities can help ensure meaningful insights are not siloed but rather maximized to elevate data quality and patient safety.
Understanding the benefits
Regardless of the changing clinical development landscape, the one constant for all industry stakeholders is prioritizing patient safety and improving patient outcomes, where data quality plays a key role. As sponsors consider modern approaches to monitoring, understanding the “why” of changing their approach matters. Several key benefits to RBM and centralized monitoring, include:- Real-time visibility and automated identification of
- monitoring insights to make adjustments quickly.
- opportunities to proactively investigate to reduce the proliferation of potential errors or instances of non-compliance with the protocol.
- Early signal detection and subject-level data review
- helps to achieve high data quality and integrity, thus avoiding end-of-study delays.
- Automating processes to drive faster actions can:
- accelerate data availability for reporting study results,
- reduce overall timelines to potentially get therapies to market faster.
In addition to clinical monitoring improvements, these methods can lower the total cost of clinical monitoring for a clinical trial by as much as 40%, and when adopted at scale across an enterprise, generate opportunity to invest those savings in more clinical research.
We now have a tangible example of how adversity can inspire innovation. If you wish to capitalize on the momentum for change and transform your clinical trial monitoring approaches, learn and co-discover with our experts as they share insights from more than a decade of experience in executing risk-based approaches to clinical trial monitoring across a full spectrum of outsourcing solutions (Staff Augmentation, FSP Outsourced, FSP Advance, End-to-End Full Service Delivery).
Please contact us directly to learn more about FSP capabilities and other outsourcing solutions specific to centralized monitoring or please visit globalFSPGTM@iqvia.com.
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