PPD’s patient data dashboard: Moving data review forward today and beyond
The importance of reviewing data has always been key to ensuring both patient safety and trial conduct. But, in a world where the volume of data is growing exponentially, it is becoming harder for traditional approaches to provide comprehensive, easily reviewable clinical data. COVID-19 has further illustrated the need for quick action and PPD’s Preclarus® Patient Data Dashboard, an already established solution for vaccines studies, is already making a difference for our clients. Clinical review demands now require data to be analyzed and interrogated immediately to provide actionable intelligence to a variety of audiences. PPD has changed the landscape for reviewing data collected during clinical trials in several ways.
- Scheduled print out review cycles are a thing of the past. Teams can now define questions on the fly, based on what they are seeing and get answers just as quickly.
- Location restrictions are removed so teams can have access from anywhere. Reviewers are globally spread across the world and increasingly in home-based settings. Now, with immediate global access to data from an increasing multitude of data sources, wearable devices, virtual sites and eCOA are bringing portable near real-time decision-enabling data to a rapidly expanding variety of reviewers. Our solution is ideal for functional service provision as the same content is shared consistently to clients and providers alike and can be accessed seamlessly from anywhere.
- Interactive, comprehensive and relevant reviews are combined. Information is now dynamically presented in such a fashion as to assist in the timely evaluation to allow precision/targeted review. For example, AEs can be plotted against important study milestones, abnormal labs, study treatment, concomitant medications and medical histories, etc., highlighting key safety and efficacy signals at the study or compound level.
PPD changed the way it reviews data with the Preclarus Patient Data Dashboard, utilized by 500+ distinct users deployed over 130 individual studies on 11 integrated compounds. Preclarus is PPD’s award-winning technology solution that consolidates and standardizes relevant data from multiple sources into a centralized visualized reporting dashboard, providing internal and client teams with interactive dashboards designed to deliver insightful visualizations and the data needed to drive actionable intelligence.
PPD’s near real-time and comprehensive solution is made possible using various industry standards, namely the Standard Data Tabulation Model (SDTM) from CDISC® (Clinical Data Interchange Standards Committee). This approach collates the clinical data captured into one organized structure. The Preclarus Patient Data Dashboard is designed to load SDTM into a comprehensive, web-based, visual and interactive environment powered by TIBCO Spotfire. This is combined with PPD’s rapid SDTM development, which results in scalable, available and timely data right from study start on a frequency (daily, weekly, monthly, etc.) required by our internal and client review teams.
Reviewing individual studies interactively is a powerful experience, but we also have learned that through these standards, the combination of data across a compound or program is a very powerful option. PPD’s solution allows for all our clients’ data, regardless of where it was generated, to be presented seamlessly in an integrated compound dashboard. This review is further enhanced by the introduction of alerts, drawing the reviewers’ attention to key occurrences and being able to filter out data that was previously reviewed.
In terms of real successes, this novel approach has cut timelines and costs by allowing reviews to occur in near real time. Study teams are no longer tied to seeing data for the first time at scheduled review meetings. Instead, they are able to review it during the study’s progression. This actionable insight allows proactive preparation to occur for rapid action, such as no pauses in patient recruitment.
The Preclarus Patient Data Dashboard ensures that the right people, get the right data, to make the right decisions at the right time.