Keeping Trials on PACE by Effectively Identifying, Mitigating and Monitoring Risk
Adaptive Monitoring Strategies
Medpace deploys an adaptive approach to clinical trial monitoring that directs focus and activities to the areas of greatest need which have the most potential to impact subject safety and data integrity. The key components include:
- Protocol Evaluation: Focuses on identifying critical study aspects, risks and potential mitigations
- Centralized Monitoring: Ensures the proactive and early identification of quality, safety and operational risks. This is conducted remotely via centralized data reviews and remote monitoring visits
- On-site Visits: The frequency of on-site visits is broadly set at the study level with an expectation that through centralized data review, sites will be identified that warrant additional time on-site.
“The Medpace advantage is the high level of clinical review given to your protocol risk assessment. In addition to the operations team, Medical Monitors, Advanced Nurse Practitioners, and Clinical Data Reviewers provide unique insights and perspectives that results in a more holistic and effective strategy.
“Striking the appropriate balance between on-site and centralized monitoring activities, we continuously assess results and risks, maintain standards for patient safety and data quality, and adapt as necessary.”
Developing a sound, strategic monitoring strategy requires upfront planning and ongoing review. We apply our RBM framework to each study to deliver the most efficient monitoring strategy while protecting the welfare of patients and data integrity. Our goal is to ensure that both the study team and sites are focused on the most critical aspects of the study. The framework has four primary stages as well as a fifth stage which doesn’t start or stop, but involves continuous adaptation:
- Protocol Evaluation: Each study undergoes an initial risk analysis and assessment to determine the appropriate monitoring plan. A thorough protocol review will help determine the right combination of remote, on-site and centralized monitoring. We conduct a holistic, cross-functional risk assessment at the study/program level and then take a deeper dive at the protocol and site levels.
- Continuous Centralized Data Review: This is an ongoing activity that includes both medical surveillance reviews and operational oversight including:
- Oversight of study and patient level clinical data
- Early identification of safety signals
- Endpoint management
- Site quality oversight
- Protocol noncompliance
- Missing/inconsistent data
- Data outliers
- Unreported events
- Risk Remediation/Ensuring continued data quality and patient safety: Any areas of increased risk that have been identified are communicated to Sponsors and Sites by Clinical Trial Managers, Medical Monitors, Clinical Research Associates and Data Managers These risks may be identified in a number of different ways including:
- Centralized data review
- Site contacts
- Data queries
- Onsite monitoring visits
- Remote monitoring visits
Medpace provides an interactive analytics platform which combines multiple sources of unstructured data into easy to use dashboards. All primary sources of critical data from internal data sources (e.g. central lab, EDC, IRT) and external (EDC systems, Electronic Health Records, eConsent, eDiaries, direct to patient (home health, study product, study supplies, travel support)) sources are integrated so that large amounts of data are consolidated and reviewed. Through our platform, we can shape and visualize the data to identify trends, outliers and other points of interest. This allows our teams to quickly visualize and interact with the large volume of data, whether it be operational or clinical data, to support forward-looking study decisions. Additionally, the self-service interactive dashboards allow study teams to easily customize and share their findings.
Integrated data allows for the development of:
- Customized study-specific dashboards based on unique project risks
- Reports and visualizations at patient, site, country, study, program levels to perform review of pertinent data and allow for analysis of trends and outliers
- On-demand access for internal and external user oversight
Medpace’s RBM technology allows our team to identify anomalies, mitigate risk, and escalate issues as necessary. For Clinical Research Associates (CRAs), several aspects previously spent on-site can now be monitored remotely, reducing the frequency of on-site visits while still maintaining monitoring effectiveness. CRAs can focus on site relationship and quality driven by technology/centralized data review.
Risks can arise at any stage of a study. Medpace provides comprehensive cross-functional expertise to effectively identify, mitigate and monitor risk throughout the study duration. A key differentiator of Medpace is the extensive involvement of our physicians throughout study conduct. RBM is no exception as medical surveillance and ongoing clinical data reviews are led by Medical Monitors and supported by Advanced Nurse Practitioners, safety coordinators and a dedicated team of clinical data reviewers who follow each patient through their study experience. The study leadership team of Medical Monitor and Clinical Trial Manager ensures a continued focus on clinical as well as operational data.
“One size does not fit all; we partner with sites to develop custom strategies that best align with their capabilities.”
Medpace has developed and maintained strong working relationships with hundreds of investigators and research sites over the years. As we implement study level monitoring changes we work closely with sites to adapt strategies that best align with their specific processes. Avoiding additional site burdens are critical factors in building out the monitoring strategy.
Reducing patient burden is also critical in developing study designs and operational strategies. The shift to decentralized services has had a tremendous impact on patient engagement and the management of patient requirements. Reduced patient and site burden is a key objective. Decentralized services has also expanded utilization of vendors offering an array of services from home health to wearable devices. Medpace has partnered with vendors in every patient service sector – putting in place Master Service Agreements and developing data integration pathways. These partnerships enable us to quickly set up study specific services as the needs arise.