A New Industry Standard: Raising the Bar on Data Monitoring
In the following blog, Worldwide provides insights on how it is setting a new industry standard on data management using the Comprehend Clinical Intelligence platform to optimize and monitor in a variety of trial use cases.
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Recent changes in the clinical trial industry have created new obligations and requirements for oversight and review. The addition of E6(R2) to the ICH’s Good Clinical Practices (GCP) brings increased expectations of trial oversight and a focus on risk-based delivery, adding to an industry-wide desire for improved reporting and central oversight. These recent regulatory changes mean that a once-preferred feature of clinical trial protocol is now an imperative. This regulatory update is complicated by the diversity of needs for different clinical trials. While all trials share a core set of operational oversight considerations, most trials also require some degree of customization to ensure their unique goals and regulatory obligations are met.
Worldwide goes beyond the standard oversight offered by alternative CROs for trials with common needs. One way we do this is by leveraging partnerships. One best-of-breed partner that we work with is Comprehend, whose Clinical Intelligence solutions ensure complete, aggregated data for optimal trial oversight, reporting, and compliance success.
Comprehend enables data from multiple sources to be aggregated within the drug study – powering more impactful reporting and visualizations, operational oversight, and central monitoring. The solution is quickly configurable and ingests almost any type of data to support trial oversight.
“The latest advances in data science make it possible for clinical trial sponsors to gain control over risk and adhere to ICH E6(R2),” says Rick Morrison, Comprehend’s Founder and President. “We’re proud to join Worldwide in its effort to exceed sponsor expectations for oversight and performance.”
To demonstrate the benefits of the Comprehend data management platform in real-world situations, we have provided three typical use cases.
- ICH compliance: The latest revision to the ICH E6 regulations requires that sponsors and CROs demonstrate improved operational oversight. What is needed depends on the fit-for-purpose needs of the trial and is determined through risk assessment. We often look at site-level performance and other risk management activities. This may require the use of existing reports or the creation of custom reports and identification of key risk indicators to monitor patient safety, data integrity, regulatory compliance, and operational delivery.
- Complex trials: More complex trials may have operational complexities that can be managed better through custom analytics. In our test case, we implemented a large phase III trial with a complex eight-week screening window. There were five visits in this period, with data coming from multiple vendors and subjects needing scheduling at imaging sites within specified time intervals. Adding to the complexity was the high number of patients to be screened. It would be nearly impossible to manage this process manually or to execute across different systems. The Comprehend platform enabled custom-built reporting to support the operational oversight of this crucial study period and to aid in the central medical review of the data, thus ensuring that patient screening decisions were made appropriately.
- Small trials: It is not just the larger and more multifaceted trials that benefit from the Comprehend system; we routinely use Comprehend for smaller oncology studies. In this use case, the operational challenges are not as complex as those of a trial with a high patient volume, but the nature of the patient data is more complicated. We focus on clinical data visualizations to support data review. Graphical patient profiles and clinical data review solutions help to provide efficient data review at the patient level and overall data oversight at the site and study levels.
For any size trial, you need a data monitoring process you can rely on to ensure regulatory compliance, robust evidence, and patient safety. When you need uncommon data management, rely on Worldwide’s award-winning expertise.