The State of Data in Clinical Trials
As the clinical trial industry continues to generate massive amounts of data, the need for efficient data collection and integration has only increased. 異種システムを使用して治験データを収集する現在のプラクティスでは、研究者が治験実績を管理し、開発中の治療法についての貴重な知見を明らかにすることが困難です。
According to the Tufts CSDD Impact Reports:
- The amount of clinical data being collected has grown dramatically due to increased scope and complexity of study protocols
- 77% of sponsors and CROs cite difficulty loading data into their primary EDC system due to compatibility, technical demands, and integration challenges
- Sponsors and CROs use an average of six different applications to support clinical trial activities
Benefits of Data Integration
Technology that allows sponsors to not only aggregate but integrate study data can greatly improve trial efficiency. Rather than trying to compare data across multiple platforms, study managers who use these holistic tools can view standardized data that leads to actionable insights in one place. This also enables easier and faster comparative analysis.
Using a tool that integrates data from multiple applications comes with additional benefits, such as:
- Decreased manual processes, reducing the burden on study teams and potentially lowering trial costs
- Improved study collaboration, allowing for better visibility across critical trial data
- Increased trial oversight, reducing risk and performance issues
As sponsors and CROs continue to search for data management options that allow them to avoid system and process fragmentation, technology and data analytics organizations can step in to address these concerns.
Finding the Right Data Management Solution
An effective data management and analytics solution must include the ability to access a centralized reporting environment. Data that is shared in real-time or near real-time can be critical in improving trial performance as it allows sponsors to make proactive, impactful choices that can keep studies on track. For example, a sponsor can find patterns that indicate that a site is struggling with patient compliance. By proactively communicating with the study team, the sponsor can identify the root cause of the non-compliance and improve data collection sooner.
Sponsors should also look for a solution that provides them with reports that fit their needs. For some studies, a conventional reporting option pre-designed by the analytics provider is sufficient. In other cases, when a study is more complex in terms of number of endpoints, geographic scope, or other factors, a sponsor may need a custom reporting option designed to fit their needs (Figure 1).
Figure 1: Custom Reports Meet Sponsors’ Unique Trial Needs
Because every decision impacts the probability of study success, sponsors should also consider using a risk-based management tool that can help them overcome uncertainty and take control of the study through risk assessment and proactive mitigation. This improves trial performance factors such as enrollment, site compliance, safety, and quality.
Sponsors want data analytics solutions that empower them to take a deep dive into the data they collect, so they can feel confident that they’re making the right decisions for their trials, sites, and patients. Rather than reacting to trial data and trying to retroactively problem-solve, they want normalized, real-time data from multiple sources that allows them to take control and avoid study delays or non-compliance issues.
There is no doubt that the clinical trial industry is facing a shift toward a more unified, integrated research experience. The technology that offers such a simple, user-friendly solution is available, and the capabilities of data management platforms will only continue to advance and develop.
Drew Bustos is the Sr. Director, Business Intelligence Products at ERT.