Trends in Clinical Trial Data

The clinical trial world is experiencing a considerable increase in the quantity of available clinical data. In this video from the June 2014 ClinOps Toolkit meetup event, Marc Desgrousilliers, CTO of Clinovo delves into emerging trends in clinical trial data.  Most importantly, the increasing quantity of patient and clinical trial data (more sources, more complexity, more real-time) puts data quality at risk.  Open-source electronic data capture is one tool that can be deployed to balance the need to protect patients’ safety through increasing data quality and reduced costs.

4 Trends in Clinical Trial Data

1. Real Time Data

As opposed to paper-based studies that require months before even looking at the data, clinical teams expect to get access to the data in real-time.  New technologies are giving the pharmaceutical industry the ability to gather large quantities of real-time, real-world data. It allows them to react faster, protect patient safety, identify sites that don’t perform. That translates into saving costs.

2. Patient-centered trends in clinical trial data

Clinical trials are capital intensive because of the required infrastructure, resources, and time. How can we rely on the patients themselves to provide more data? Remote monitoring of patients through sensors and devices offers a new horizon to extend clinical trials beyond the boundaries of clinical sites. New, smarter devices and fluid data exchange on the cloud equals more data collection, in real-time.

3. Multi-source trends in clinical trial data

Growing sources and flow of clinical trial data present potential a problem: EHR / EMR / ePRO / Big Data (genomic) => Clinical data conversion.  The solution for data conversion is integration and gateways between legacy systems achieved through common standards (CDISC ODM, HL7, what’s next?).

4. Self-service trends in clinical trial data

Complexity and cost of vendor selection and implementation gives way to the trend of “do it yourself” systems. No longer do biotech and medical device companies need to commit to a technology stack.  Lower cost, cloud-based solutions allow you to write your own studies, build your own company-specific databases, own your CRF libraries, design your own metrics and reports. Subscription-based “pay-as-you-go” cloud-based software solutions eliminate the need for high upfront IT investment.

Rebecca Alvarez introduces Marc Desgrousilliers at the June 2014 ClinOps Toolkit networking panel event.

Rebecca Alvarez introduces Marc Desgrousilliers at the June 2014 ClinOps Toolkit networking panel event.

These technologies allow systems to be scalable, integrated, and accessible from anywhere in real-time.  Now you do a better job of risk-based monitoring (RBM). Solid integrations with Electronic Medical/Health Records (EMR/EHR) pave the way for enhanced data precision & quality. Again, there is the benefit of cost savings for quality data.

Trends in Clinical Trial Data Presenter: Marc Desgrousilliers

A 20+ year industry expert, Marc is Chief Technology Officer at Clinovo.  Marc is responsible for evaluating emerging technologies suitable for the biotech industry, developing the corporate information technology, ensuring industry regulatory compliance and developing clinical systems and infrastructure for sponsors. Clinovo provides an EDC system called ClinCapture for more than 40 clients, from 20 up to 20,000 patients.

About Clinovo

clinovo

Clinovo partners with life science companies to streamline their clinical trials, leveraging years of expertise in systems integration, open source technology and industry standards. Clinovo provides Staffing Solutions, eClinical Systems and Biometrics Services including Clinical Data Management, Electronic Data Capture, CDISC mapping and SAS Programming. Clinovo also offers TechTrainings, a 10-week series of technical hands-on classes for clinical trial professionals to reach the next step in their professional career.

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About The Author

Nadia

Nadia Bracken, lead contributor to the Lead CRA blog and the ClinOps Toolkit blog, is a Clinical Program Manager in the San Francisco Bay Area.

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