Exploring the Impact of Data and Informatics Technologies Throughout the Clinical Trial Journey
The pharmaceutical industry has gradually evolved to recognize the value of leveraging external real-world data and improving internal clinical data management processes. It’s not surprising given the ever-increasing pressures to fast-track development and uncover new efficiencies in today’s complex trial landscape.
From early feasibility to monitoring and reporting, we explore current challenges in each area and how various data sources are being collected, aggregated and applied with the use of informatics. Learn how using comprehensive analytical capabilities that impact decision-making helps to advance clinical trial execution.
Evaluating feasibility and site selection
Accurate forecasting and benchmarking helps sponsors quantify the speed of patient enrollment and understand the impact of the enrollment criteria. Sponsors often rely on past literature or legacy protocols for defining primary efficacy parameters and estimating the number of patients required, but this is an error-prone process.
Now sponsors are broadening their information sources and taking advantage of aggregate data sources, such as the global clinical trials processed through a central laboratory repository. These proprietary sources allow sponsors to evaluate the current competitive landscape, estimate relevant patient populations, identify ideal site locations and assess the impact of eligibility criteria on recruitment and retention.
Informing decision-making and viewing performance
Once a protocol is finalized and the trial is underway, it is crucial to identify problems, actively manage risk and intervene before issues affect progress, but disparate data collection systems must work together to enable this holistic view.
Sponsors need a way to unite multiple platforms through one robust clinical trial management system that collects, validates, consolidates and integrates clinical trial data, allowing critical trial operational elements to work together. Seamless communication with the source systems help maintain a complete audit trail.
Identifying and mitigating trial risks
The latest revision of ICH GCP E6(R2) encourages the adoption of quality-by-design and quality risk management methodologies in clinical trials, but many sponsors are still hesitant on how to transition to a risk-based monitoring approach.
Creating technology-based functions like medical review, data review and statistical monitoring allows sponsors to receive a broader, more flexible view of clinical data and quickly pinpoint risk. Informatics integrated with risk-based management (RBM) can enhance patient safety and data quality.
Enabling stronger collaborations
Keeping up with reports from multiple partners and sharing statistics on operational performance can be a cumbersome process. Many sponsors struggle to make sure that their teams are all on the same page and informed with the latest information to make timely decisions.
Many technology solutions can enhance information exchange and provide up-to-date status reports. For example, a solution should contain a secure interactive dashboard to share project documentation and store other sensitive information and sends teams up-to-date summaries of operational data to help track a trial’s progress.
Aggregating multiple data sources
Traditional clinical trial management systems fail to solve complex reporting needs in operational data management. Evaluating trial execution to track study milestones, monitor site performance and generate reports requires navigating multiple data sources and manually assembling data – a non-scalable and costly scenario.
Meeting a trial’s operational and clinical objectives requires efficiently integrating disparate data sources. For example, an operational data warehouse focuses on data quality, patient safety, timeline and costs while a clinical data warehouse ensures that the collected data are “fit for purpose” and monitors drug-related safety issues.
With today’s complex clinical trials, unnecessary data quality issues or delays in trial execution can lead to significant loss of revenue. Sponsors are turning to intelligent informatics-based solutions to help ensure that the design, planning, and conduct of clinical trials proceeds in the most informed, efficient and effective manner possible.
Learn more about the use of informatics in clinical trials by attending Covance’s informative webinar.