How Next Generation Data Visualization Tools Enable Real-Time Efficiencies in Clinical Trials

Discovering Meaningful Insights and Driving Smarter Decisions

Abstract

The ability to manage and analyze the data collected in studies and identify hidden patterns in patient behavior can help sponsors run efficient and successful clinical trials. Visualization tools for the management, reporting and analysis of key trial information can play a crucial role in gaining insights into patient behavior, enabling those running a trial to react in real-time to vital trial information and patient and site data. This in turn enables study teams to discover meaningful insights and drive smarter decisions. This article will highlight how implementing reports and visual dashboards may enable sponsors and study teams to streamline data collection so that patients and sites get the necessary attention at the right time. Such solutions offer a way to track compliance and react in real-time to medical alerts based on patient insight, distilling the most meaningful clinical trial data to gain a better perspective of sites and patients.

A Changing Industry

Clinical trials are constantly adopting new digital technologies and the line between clinical trials and digital health is no longer clearly discernable. Clinical technology companies are utilizing digital health to improve clinical trials and these new technologies bring the potential for data to be continually collected, for instance temperature or blood pressure measurements. While integrating sensors and devices in clinical trials results in more data, the challenge may come in evaluating the sheer volume of data to identify if a drug is achieving its targets for safety and efficacy. To keep ahead in such a rapid industry, stakeholders are being driven to implement an array of innovative strategies to retain a viable lead. With enhancing operational efficiency and minimizing costs more important than ever, clinical trial providers worldwide are progressively relying on data analytics to keep pace.

Optimizing Processes

There is increased pressure to monitor clinical trials more effectively and this is where technology, when used efficiently, can help to optimize processes. For example, patient-focused electronic clinical outcome assessments (eCOA) technology has already made studies more efficient, cost-effective and less intrusive. eCOA encompasses PROs (Patient Reported Outcomes), ObsROs (Observer Reported Outcomes) and ClinROs (Clinician or Rater Reported Outcomes). Through innovative technology, a thorough understanding of drug development, and mobile computing, such as patient-focused solutions are driving the change to higher quality outcomes and more efficient paper-free clinical trials. However, running a clinical trial is still a complex operation due to the greater geographical reach of the trial, greater numbers of patients and much greater amounts of data to manage.

Embracing Data Visualization to Manage Data

Sponsors, site teams and patients in the clinical trials arena are embracing intuitive solutions that are designed to simplify the path to approval and deliver reliable results. In the context of eCOA studies, KPI dashboards and reports are crucial to enable study teams to streamline data collection. However, the ability to simply capture patient data is often not enough; the resulting data set needs to be robust and reliable, and sponsors and sites need to manage the process in the most efficient way possible. For a successful trial, analysis of site and patient metrics needs to be proactive and areas requiring special attention flagged quickly. In addition, too much unnecessary information can be as burdensome as not enough of the crucial data. Solutions are needed that can filter through the data, allowing for smarter decision making, and when necessary, quick intervention. Sponsors and study teams may benefit from effective reports for managing KPIs, which might include some of the following:

Figure 1.

• Study Team Metric Reports – to enable identification of significant trends and deviations, allowing for real-time reaction and intervention (See Figure 1)
• Site Staff Metric Reports – to enable site staff to identify instances of low compliance or missing data
• Eligibility and Enrollment Reports – to enable site personnel to review subject inclusion criteria alongside subject data
• Compliance Reports – to ensure studies align with regulatory requirements and study protocol
• Data Management Reports – to ensure clean, accurate, high quality data
• User Activity Reports – to enable the study team to identify volume of user activity and identify those requiring assistance

But what makes a good visualization tool? Many people would suggest it should be interesting, include charts, be easy to analyze and allow drill down to details or selection of specific data, e.g. time frames. Ultimately it should be intuitive, especially in finding any problems, and actionable. Interconnectivity is also a crucial feature in today’s connected global world - the ability to be “always connected” makes it easier than ever to gain new insights into patient behavior, pool data to create visualizations and react in real-time to key trial information.

Making Study Management More Manageable

Although the benefits are compelling, many companies struggle to extract the appropriate insights from accrued data. So how can study teams running clinical trials make the most of the vast amount of data and use it to their advantage? The key lies in analytics and being able to visualize the data to make it more accessible. Below are seven key steps worth considering when it comes to implementing visualization tools to facilitate real-time study management:

• Make Trial Data Actionable: A visualization tool needs to allow study teams to be able to view trial data in an accessible way. This could include color-coded data visualization for instance. The ability to visually view trial data makes it easier to identify meaningful data trends and detect important exceptions, so that the information can be put into action.
• Focus on The Most Relevant: Identify what kind of report would be most useful. Reports such as role-based reports and dashboards that deliver key metrics at-a-glance, whether monitoring individual patients, surveying global site-level metrics, or an entire trial might be most valuable.
• Analyze Across Multiple Dimensions: Interactivity is often vital when it comes to data. The ability to explore data in real-time with easy-to-use interactive dash-boards and graphs would be of obvious benefit. This would enable the user to quickly drill down, filter and compare trial data between regions, countries, sites and individual subjects.
• Save Time with Best Practices: A visualization tool that includes a library of best practice report templates or allows the development of custom reports to suit a study’s specific needs would save site personnel time and help adhere to best practices.
• Consolidate Oversight: If a study can quickly pinpoint lowerperforming sites, then early intervention can happen. Additional support resources and training can also be facilitated. This would allow best performing sites to be identified to enable success to be replicated.
• Boost CRO Performance: Utilize the data to help solve problems. Independent objective measures can be leveraged to resolve issues with individual site compliance or consistency. (See Figure 2)
• Lower Monitoring Costs: Data can often provide meaningful insights into how certain aspects of the trials are operated. By proactively identifying and monitoring at-risk sites it allows sponsors to take targeted corrective action.

Figure 2.

The Benefits of Real-Time Study Management

By utilizing online portals and visualization tools, sponsors and site teams can monitor and manage a trial in real-time and instantly explore and review data collected. It allows those operating clinical trials to react to potential medical alerts, encourage patient compliance with email and text message reminders and gain new perspectives on site metrics and patient behavior.

Errors and inconsistent reporting increase variability in the data set and can even necessitate further subject recruitment. Managing data effectively enables study teams and site staff to quickly recognize and address inconsistencies and discrepancies, thus reducing regulatory risk, achieving earlier data reconciliation, enabling faster database lock and optimizing trial efficacy.

Designing Effective Reports

Realtime portals for the analysis and management of data collected in clinical trials provides visual access to key trial information and supports the analysis of patient and site data. The ability to analyze data in a visual and accessible way makes it possible for study teams to gain new insights. In a recent study of diabetes, visualization tools have been used to analyze data to identify patterns in meal reporting, glucose measurements and hypoglycemic events. The ability to create reports and analyze the data, provided the study team with an understanding of how timely patients report meals, enabling the site staff to optimize retrospective data entry capabilities to balance accuracy and volume. Ultimately, this type of insight ensures the capture of higher quality data and drives more detailed analysis.

The ability to instantly explore and review data collected has obvious benefits, but how can sponsors and site teams make the most of realtime monitoring and management? The following top 10 tips may provide some guidance for designing effective reports for eCOA trials:

1. Engage early with the eCOA vendor to identify the required reports and ensure all necessary data is captured from the beginning of the study
2. Include key team members in report design to ensure their needs are met
3. Design reports with respect to how they can affect monitoring plans and what actions need to be taken
4. Save time and eliminate errors by having the report perform calculations
5. Identify areas requiring action, using data visualization tools like color coding to highlight outliers or areas of concern
6. Use filters to drill into the data interactively to see what’s happening quickly and why
7. Focus on priorities for specific study team members, customizing reports and dashboards by role
8. Add reports when needed as the study progresses
9. Choose reports that best suit study requirements, taking only the information needed
10. Track report usage to identify which are more used and tailor the reports accordingly

An accessible flow of instantaneous, visual information enables those monitoring the trial to act on any risk factors, ensuring compliance in real-time. Perhaps the time is right for the clinical trials industry to embrace the new capabilities, experiences and opportunities that next generation visualization tools can bring.

Extending Beyond Clinical Trials

Data visualization tools are not only applicable to running efficient clinical trials; analytics play a vital role in the vast healthcare landscape too. The ability to monitor continuous data from a wearable device, for instance, and transmit information from a patient’s home via Wi-Fi or smartphone to a data analysis server where reports can be generated and analyzed instantly, is an area that will only continue to grow. With the global pharma market set to be worth as much as $1.6 trillion by 2020,² the opportunities for companies to improve the efficiency of drug launches using analytics are vast.

References

1. https://www.fiercebiotech.com/cro/econsent-software-becomes-wirb-copernicusgroup-s-recent-buy?utm_medium=nl&utm_source=internal&mrkid=49835242&mkt_ tok=eyJpIjoiTm1ZelkyTTVNMk5sT1dFNSIsInQiOiJ5TTlvd2tlQ3lXekkzNlQ1ZEtHWVI5RWp2Sl diSDdXYmIyc2Y1bFBKSTY1amVjZFZHbEJ5d3VXa3NHMUFrZEFkd1REOU9BKzBtcHV6RE8 4NDJPVzVEeEk0SEIzd1g2bUpTYnk2TW5oODhReXZOT2pOUHRjWG0xNSt1ayt1UGhCMiJ9
2. http://www.information-age.com/winning-analytics-pharmaceutical-industry-123465730/