Ensuring Clinicians Obtain the Right Data at the Right Time

Trials can often experience impediments great and small. Here’s how unified analytics platforms can provide real-time data for more accurate, expedient review.​​

Designing, launching and implementing a clinical trial for an investigational product (IP) is vastly rewarding for the entire team when the data analysis is a smooth, trustworthy process. It is the data that can make the difference between approval and rejection of the IP for commercial success.

Keeping data clean, complete, submission-ready and on time is the priority. Unified analytics platforms enable study teams to spend more time on high value analysis and interpretation, and less time being bogged down by manual data compilation. This is especially critical for startups and small companies.

Success in clinical research is not just dependent on the accuracy and integrity of the data, but in the speed, agility and flexibility on how that data is interpreted. These are also critical components because, as the recent pandemic has exemplified, sudden changes during the course of the study can have a dramatic impact on all aspects of the trial, including data collection and review. Any alteration can cause vulnerabilities leading to misinterpretation, which may eventually culminate in nullification.

The pace, complexity, and volume of data generated in a trial means that medical monitors, safety review teams, data managers and others working with clinical data need interactive solutions that enable real-time analysis and faster decision-making. Further, the ability to explore data in safety and efficacy domains to ensure patient safety, identify trends, monitor study progress and assess data quality is compounded by the fact that team members also need to be able to track the review progress of their clinical data.

As any trial progresses, the ability to spontaneously review accurate data as it is incoming is critical to providing actionable information for anyone at any point during the process. As any trial progresses, building visualizations from rapidly multiplying lines of data becomes an enormous task for expedient data review. “Data review is a team sport,” emphasized Brent Meyers, clinical business unit director for PerkinElmer Inc.

Promoting Unity​

Unified analytics platforms allow for the seamless integration of data from a variety of sources (such as patient reported outcomes, local labs, central labs, trial management systems, electronic data capture). The data is then collated into one dynamic resource where it is always fresh, timely and relevant.  The collected data is centralized, automated and refreshed allowing for clinicians to access to the correct data at the right time. The ability for a clinician to go straight to their data instead of having to pay for a vendor or CRO to access it is a boon, and it also saves the clinician significant amounts of time.

Unified analytics platforms also make it easy to continuously monitor incoming data and clean it when necessary. It also provides an opportunity to flag and correct a protocol violation before it threatens the study’s progress. Study managers, biostatisticians, medical monitors and others can spend their time exploring and analyzing an array of dynamic, purpose-built data visualizations, rather than reworking outdated reports and wrangling data into safety and efficacy plots.

Further, unified analytics platforms facilitate translational and clinical use cases through a portfolio of purpose-built solutions – i.e., common interface across use cases. Each solution is designed to integrate smoothly together and ladder up to the centralized platform, resolving the “gap issue” that can compromise data as it jumps between different vendors’ tools. As a result, biostatisticians, medical monitors, CROs, sponsors, and other stakeholders across the clinical study lifecycle function as a single team moving towards a shared purpose.

Lining Up​

During the course of a trial, clinicians may need to review and gather intelligence. Questions often arise that need to be answered quickly and accurately. They include:

• What is the status of a particular line listing?
• When and how many other reviewers have reviewed it?
• Does a line listing have an anomaly in it that needs to be queried further?
• Has a line listing been amended since it was last reviewed?
• Is there an audit trail of all the review activity?

Line listing review adds a layer of visibility and facilitates tracking, especially when seeking any outliers.

Further, line listing review is important to satisfy ICH guidelines, fulfill the need for the sponsor to track data/medical queries and to ensure to the FDA upon request that these issues were taken care of properly. PerkinElmer Informatics’ Signals^®​ Line Listing Review leverages TIBCO Spotfire’s interactive capabilities to provide easy access to granular data and to meet these important needs.

“The value add of Signals^®​ Line Listing Review is the ability to get all of your data in one place, refresh regularly, spot outliers, see in the context of all of your data and then keep track of your review process and communicate that to other parties,” Meyers described.

Other key benefits of this tool include improving safety review efficiencies for multiple teams, reducing timelines to critical study milestones such as database lock, and expediting clinical data review process in Spotfire.

PerkinElmer Informatics is a provider of analytics solutions powered by TIBCO Spotfire for all phases of clinical development.

PerkinElmer Informatics’ unified integrated analytics platform is the only one on the market powered by global analytics leader TIBCO Spotfire® and is designed to facilitate translational and clinical use cases through a portfolio of purpose-built solutions that are designed to integrate smoothly and ladder up to the centralized platform -- resolving the “gap issue” that inherently compromise data as it jumps between different vendors’ tools.

With PerkinElmer Informatics solutions, biostatisticians, medical monitors, CROs, sponsors, and other stakeholders involved in the clinical study lifecycle can collaboratively function as a single team to achieve an approved and commercially available therapy.