In the Face of a Pandemic
COVID-19: A Wakeup Call for Clinical Trial Monitoring
Clinical trials have two key goals: to prove the safety and efficacy of new therapeutics. Their success rests on the accurate collection, monitoring, and analysis of data. While today’s data collection is increasingly electronic, monitoring itself still largely occurs onsite, with monitors verifying source data by physically comparing the electronic data capture with the data in a patient’s medical history.
The recent COVID-19 virus highlights the vital importance of changing this model.
With governments everywhere asking people to practice social distancing or shelter in place, monitors are not able to get to sites—and clinical trial subjects aren’t able to get to investigators—creating a challenge for both data collection and monitoring. This threatens to derail trials at all stages, as well as potentially putting trial subjects in harm’s way. It doesn’t have to be this way.
At Issue: A Technology Gap
Over the past decade, sources of data have increased—from new diagnostic tests to wearable data collection devices to data from electronic health records.Continue reading...
That data sprawl makes data management increasingly complex and monitoring it increasingly daunting. Still, for clinical trials the ability to identify and eliminate fraudulent data is essential both to ensuring safety and proving efficacy. Unfortunately, it is also challenging, given current methodologies.
While scientific advances have surged ahead, the technologies used to manage clinical trial data are mostly holdovers from the 1970s and 1980s. They resist integration and lack built-in analytical processes. This severely impacts overall data monitoring and management.
Study monitors mostly follow traditional data monitoring processes, relying heavily on 100% source data verification (SDV), with relatively minimal remote monitoring. Ironically, these conventional methods capture surprisingly few errors; technology could do better.
Alternative Monitoring Technology Exists Today
While the pandemic has highlighted this problem, the explosion of data related to clinical trials—and the need to track, monitor, and analyze that data and all related actions—was already driving the need for change.
Fortunately, new technology exists that can provide all the necessary functionality. What we refer to as Alternative Monitoring, not only enables monitors to work remotely, but centrally accrues all data from EDC, IRT, and CTMS systems, adding a layer of technology that enables these individual platforms to interact. It also aggregates data from wearables, EMRs, and other sources, making analysis and error detection both simpler and more accurate. This advanced Alternative Monitoring technology offers many benefits:
- Shows site, patient and study data in one place
- Ensures it is both fully accessible and usable in day-to-day operations
- Supports monitoring and tracking of Quality Tolerance Limits and Key Risk Indicators
- Automatically documents all activities and plans for regulatory review
- Sounds alerts when trial-defined adverse events occur
- Harnesses artificial intelligence and machine learning to predict future risk
- Automatically assesses data to identify targeted needs for monitoring visits
- Provides a single centralized source from which onsite monitoring, remote monitoring, and centralized monitoring can work in concert
Further, because it layers atop current systems, it requires minimal investment to implement, scales to meet a study’s needs, and easily adapts to manage new data inputs.
Not only does Alternative Monitoring answer the current need for monitoring to occur at a distance, but it also underpins successful risk-based quality management—an approach to monitoring risk that has become an expectation of international regulatory bodies.
In the future, data collection methods will continue to shift and evolve, likely at an increasingly rapid rate. No one company—and no one tool—is going to collect every single piece of data.
Yet by delivering a single, centralized resource for aggregation, monitoring, and management, Alternative Monitoring can help ensure accurate safety and efficacy reporting.
The Imperative to Act Now
There is no silver bullet for the challenges of a global pandemic like COVID-19. But we can use this crisis as an industry-wide wakeup call. We must change our model for data collection and managing and monitoring studies.
Many clinical trial subjects are suffering from aggressive, terminal diseases—yet they are still willing to give their time to science to advance treatment options for others. We can do better for them. With both subjects and monitors unable to go onsite, crucial data is not being collected, and ongoing safety and efficacy metrics are not being monitored.
As an industry, it is our responsibility to ensure that we can still effectively monitor the safety and efficacy of these studies—even when the standard approach ceases to be an option. Now is the time to change our model. To learn more about the technology divide and how to solve it, click the link below to view our eBook:
COVID-19 Related Guidance
- FDA Guidance on conducting clinical trials during the COVID-19 pandemic.
- European Medicines Agency Guidance on the management of clinical trials during the COVID-19 pandemic.
- ACRO – Recommendations for the Association of Clinical Research Organizations on clinical trial monitoring oversight during the COVID-19 pandemic.