With thousands of data points collected in nearly every clinical trial, tech companies have been working to develop new ways to help teams sort out critical information. Recently, CluePoints announced the launch of Patient Profiles, a highly configurable platform that prioritizes atypical data, in an effort to help teams focus on at-risk study participants.
The software company has offered Patient Profiles as a complement to its risk-based monitoring and data quality oversight tools. The new platform uses statistical algorithms to interrogate data and highlight anomalies, similar to how credit card companies flag suspicious transactions. Clinical trial teams can use the platform to visually assess timelines of study visits, investigational drug exposure, adverse events and other patient data. The most atypical patients are highlighted in reports, which the company says could help improve patient safety and streamline review processes.
The new development follows a push from clinical trial teams looking for new tools to rapidly identify risk signals. “It was our customers that gave us the original idea,” said Patrick Hughes, chief commercial officer at CluePoints. “One specific client indicated that it would help them revolutionize their medical review process as the comprehensive statistical underpinning of the solution would allow them to surface atypical Patient Profiles and focus their attention on the most anomalous profiles in rank order.”
Ranking patients could help teams more readily identify potential trial concerns in a sea of data. “Data capture isn’t the problem, but making sense of that data is,” said Nick Payton, clinical intelligence expert, Comprehend Systems. “From EDC and CTMS to ePRO and Labs with dozens of other data sources in between, data is increasingly captured by life sciences companies. But aggregating, normalizing, integrating and, ultimately, making sense of all of these data sources remains a significant challenge.”
Steve Powell, executive vice president, Trial Oversight, at ERT agrees. Said Powell, “Trial managers are drowning in data that’s not actionable, and worse, may not allow them to truly see how trials are performing or spot issues before they become problems.”
Data mapping tools like the new platform allow users to visualize many data sources at once and identify trends, which could enhance data interpretation and overall safety monitoring. Data mapping can also reduce manual review time during trials. Clinical staff and medical monitors under pressure to move quickly during investigations can use summary graphics to explain data at the patient, cohort and site levels, and prioritize their investigations into clinical or data integrity concerns.
Properly designed data mapping platforms have the potential to dramatically improve quality management during trials, but Payton points to changing regulations as a growing challenge in the industry. “Evolving regulations place an even greater emphasis on system flexibility,” Payton said. “Between ICH E6(R2), changes at the FDA and the growing need for standardization, the industry is rapidly evolving. With these adjustments, it is no longer feasible to make a big up front investment in a rigid, customized software system only for this to be outdated in a year’s time.” New data mapping platforms must be nimble enough to adapt to these changes as they emerge, in order to be effective.
CluePoints’ launch of Patient Profiles follows a growing trend in the industry to develop new data mapping tools. Tech companies of all sizes have launched products designed to map data in ways that are helpful, visually appealing and, most importantly, streamline or even automate data interpretation.
“We’re happy to see that other companies are now investing in product development to support this need. Patient profiles are a critical piece to advancing the tools medical professionals have available to make accurate, informed clinical decisions,” Payton said. “But they are only a start; the real key is integrating patient profiles with a broader medical data review solution that can streamline and automate this end-to-end process.”
Toward this aim, Comprehend Systems has built an application called Medical Insights that helps clinical team members turn data into graphical patient profiles, with analysis tools that ultimately integrate task management and help “automate the complicated medical data review process,” said Payton. ERT has developed a cloud-based Trial Oversight platform to also helps integrate data and automate workflows with near real-time trial data mapping. According to Powell, the ERT system “allows a framework for a risk and quality-based management methodology that industry and regulatory bodies now require.” These platforms highlight how clinical trial management systems are becoming more automated.
“As sponsors and CROs move toward true risk-based management, they should look for systems that offer this type of automation and require minimal internal process changes so that they can ensure patient safety while keeping their trials on track to success,” Powell said.
The push for new mapping software platforms is expected to continue. Company representatives indicate their clients are looking for innovative ways to analyze data, and automate historically manual review processes. At present, data mapping is particularly beneficial for large trials with multiple data sets.
Said CluePoint’s Hughes, “We currently see most value being derived from phase IIb and III trials simply because they are much more rich in data and companies are experiencing the most tangible value in terms of reduced monitoring and resource efficiency. In [the] future though, we anticipate that sponsors and CROs will benefit from this type of statistical data interrogation across all phases of research.”
This article was reprinted from Volume 21, Issue 12, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »