Managing The Expansion of Clinical Trial Data Sources

Managing The Expansion of Clinical Trial Data Sources 21 Oct 2020

NEWS

by Ben Comer

Ben.Comer@informa.com

Executive Summary Increases in remote patient monitoring and decentralized clinical trials – accelerated by COVID-19 – have added complexity to data management systems. Traditional platforms and electronic data capture used by drug development sponsors are ineffectual tools for integrating new primary data sources, or managing remote patient monitoring, Raj Indupuri, CEO at eClinical Solutions told In Vivo.

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11/25/2020

Managing The Expansion of Clinical Trial Data Sources :: In Vivo

Source: Shutterstock

Recently, many of the largest biopharmaceutical companies worldwide have gotten interested in modernizing their technology infrastructures and data management processes for clinical research, said Raj Indupuri, CEO at eClinical Solutions, a provider of cloud-based software for clinical data services. The practical realities of operating during COVID-19, as well as pressure from governments and patients, are prompting a reconsideration of technology needs. Remote patient monitoring has become critical to clinical research, as well as the need to integrate an ever-growing number of primary data sources into data management systems for analysis.

The problem with data management systems, said Indupuri, is that the increase in data sources “disrupts the traditional data review process and also the patient monitoring process.” Raw data sources, such as biomarkers, biometrics and ‘omics data, for example, need to be ingested and transformed into meaningful information for analytics and for data review. Electronic data capture (EDC) systems, which are geared toward data collection, have fallen short, Indupuri said. To address this issue, elluminate, an “end-to-end data analytics platform” marketed by eClinical Solutions, was recently adopted by Bristol Myers Squibb (BMS). The platform has helped BMS overcome “pain points” in data management, including the growth of external data sources, or noncase report form (CRF) data, said David Weigand, director, clinical data reporting and analytics at BMS, during an eClinical Solutions webcast.

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The elluminate platform ingests and integrates Read the full article here › clinical data in a single repository, letting users “review all of their data together, holistically, at the trial level, or at the patient level with patient pro les,” said Indupuri. Reviewers can also compare trials sites across geographies and focus in on speci c patient attributes and subgroups across trials. The platform uses a system of governed access, so that trial sponsors can “collaborate with teams and other stakeholders … about data issues,” he said. The platform also provides data analytics for safety signal detection, or to “do an ef cacy analysis in near real time, along with risk-based monitoring or risk-based quality management.”

Indupuri said the most dif cult kinds of data to ingest and integrate in the platform currently were data from electronic health records (EHRs).

EHR data are a challenge “because of the diversity of the EHR data streams across different providers. There still aren’t standards yet.” The platform is not yet capable of extracting information from unstructured documents, such as pdf les, but Indupuri said that capability is “on our roadmap, and I think it’s something we believe will become more and more prevalent for companies to tap into.”

Getting to insights quickly was important, and traditional data analysis using Excel or SAS requires a signi cant data management effort, and had not allow for governed access, said Indupuri. Using elluminate makes it easy to

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11/25/2020

Managing The Expansion of Clinical Trial Data Sources :: In Vivo

“map data, transform the data or do incremental reviews, look at patient performance and visualizations in a single study or across studies, and do risk-based reviews.”

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