Improve the Efficiency of Safety Monitoring in Clinical Trials

Jin Kim
May 14, 2024
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In clinical trials, safety monitoring needs to be conducted in an ongoing manner to ensure participant safety and well-being, in addition to maintaining data integrity. Especially at smaller biotech companies, this needs to be done efficiently given the company’s limited resources.

However, various trial platforms like the Electronic Data Capture (EDC) and lab systems may not integrate, and it may require the medical monitor to log into each system, manually look at each of the reports, and repeat this tedious process every couple of weeks. This naturally begs the question - how about everything that happens in between those reviews?

In this article, we will go over how leveraging data effectively as part of your clinical trial management can significantly enhance the efficiency of safety monitoring.

Common Data Sources in Safety Monitoring

In a clinical trial, a biotech sponsor has a number of various clinical trial platforms to help conduct their study. Commonly found trial platforms include:

  1. Electronic Data Capture (EDC) Systems: EDC systems like Medidata Rave are the primary repositories for trial data entered by their research sites, including patient demographics, adverse events, and study outcomes. Ensuring these systems are comprehensive and up-to-date is critical for accurate safety monitoring.
  2. Lab Systems: Lab results are essential for monitoring patient safety. Lab results may be available through a central lab, which often has its own portal to view the lab data, or local labs from trial sites, which may be entered into the EDC directly. Data from these sources provide insights into patient health and potential adverse effects of the investigational product (IP).
  3. Patient Medical Histories and Concomitant Medications: Detailed medical histories and records of concomitant medications help medical monitors contextualize adverse events and determine their causality, distinguishing between drug-related issues and other factors. This information may be available from the EDC but may involve running different reports.

Enhancing Data Tools and Technologies

Information from the data sources listed above can tremendously augment the safety monitoring process:

  1. Unified Data Platforms: Integrating data from EDC, lab systems, and other sources into a single platform reduces manual cross-referencing. A unified platform streamlines access to comprehensive patient information, enhancing the accuracy and speed of safety assessments. Biotech companies often rely on spreadsheet-based tools like Microsoft Excel or Smartsheet given their ease of use and convenience of copy-pasting the data into spreadsheets, but it requires that data be refreshed manually, which can be tedious and error-prone.
  2. Real-Time Data Integration: Implementing systems that provide real-time updates ensures that medical monitors have the latest information. This capability allows for prompt identification and response to adverse events, improving patient safety and trial integrity. However, existing trial platforms may not support out-of-box integrations to your spreadsheet trackers or your existing tools.
  3. Advanced Analytics and AI: Utilizing tools with advanced analytics can automate the identification of safety signals. Common tools used across the industry include Spotfire, Miracle, and JReview. In addition to advance analytics, machine learning algorithms can sift through vast amounts of data to detect patterns that might indicate potential safety issues, reducing the burden on medical monitors, but you may first need to consolidate your data into a single platform before you can leverage AI.

Benefits of Improved Data Utilization

There is tremendous potential to tap into the data sitting in your study platforms to make your clinical trial management more efficient.

  1. Quicker Medical Monitoring: With integrated and real-time data, medical monitors can more efficiently track and evaluate safety data. This efficiency leads to quicker decision-making and more timely interventions when safety issues arise, potentially preventing adverse events from escalating.
  2. Enhanced Accuracy: Reducing manual data handling and cross-referencing improves the accuracy of safety monitoring. Consistent and high-quality data ensures reliable safety assessments and regulatory compliance.
  3. Resource Optimization: Streamlined data processes free up valuable resources that are often limited at smaller biotech companies. Clinical teams can then focus on critical tasks like communication with sites and trial management, rather than gathering data and reconciling the information from different systems.

Final Thoughts

Leveraging data effectively transforms the safety monitoring landscape in clinical trials. By integrating data sources, ensuring real-time updates, and enhancing data tools, clinical operations can achieve more efficient, accurate, and timely safety monitoring.

At Miracle, we work with innovative biotech companies on clinical trials to integrate with their existing trial platforms in a vendor agnostic fashion and provide real-time safety monitoring. Because of our integration capabilities and connectors to popular EDC systems, we can turn your reports and dashboards into an automated control room in just a few days. If you’d like to learn more about Miracle, please get in touch.

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Jin Kim

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