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eLAS — Changing the Landscape of Lupus Clinical Trials

Aug 9, 2019, 6:09:48 PM

What do you do when a well-known CRO comes to you for a data capture solution for not just one clinical trial, but for studies throughout that entire therapeutic area? You build a customized platform that increases efficiency, improves data accuracy, and can be customized to work across all clinical trials in that therapeutic area.

While it’s true that all clinical trials have challenges, studies in certain therapeutic areas such as systemic lupus erythematosus (SLE or, more commonly, lupus) can be particularly difficult to conduct. Because lupus is characterized by an aggregate of symptoms, diagnosis can be difficult.[1] This makes screening and data collection during research studies even more complex. We considered all of these factors when we developed the industry’s first data capture platform specifically designed as a scalable solution to streamline lupus clinical trials.

Tipping the Odds in Favor of Lupus Researchers

Lupus affects more than 5 million people worldwide.[2] The disease can damage the joints, skin, kidneys, and other organs, causing a multitude of symptoms that can be disabling.[3]

To build a solution that could make lupus clinical trials easier to conduct, we had to consider the obstacles researchers commonly face. We know that the challenges of recruiting lupus patients for studies and executing clinical trials on time and on budget can seem insurmountable. Strict screening requirements coupled with vague diagnosis criteria and study-specific demographic exclusions often delay recruitment. Even worse, investigators have sometimes inadvertently enrolled patients who don’t actually have lupus.

Obstacles multiply when site personnel are not properly trained on how to complete the complicated diagnostic questionnaires and other supporting documentation. The lengthy adjudication process required for lupus studies is held up even more when monitors do not have remote access to data.

Any one of these challenges can significantly delay recruitment, deadlines, and milestones — not to mention inhibit accurate enrollment. This prolongs timelines and inflates costs, both of which can jeopardize study success.

Taming the Challenges of Lupus Studies

When we started our partnership with the CRO’s lupus study team, they were already aware of our experience across many different indications and our success with streamlining data capture at the site while enabling remote monitoring. And, because our team has deep experience conducting clinical trials, the partnership was a natural fit.

We began to address lupus study challenges by leveraging our eSource technology and customizing it to fit the unique parameters around these clinical trials. Electronic scales and assessments were built into the platform to help with accurate diagnosis and measurement of symptoms as well as the collection of patient data.

Because eSource allows clinicians to enter structured and non-structured data (including numeric, text, VAS, audio, video, and handwritten notes), it increased the speed of documenting information, improved data accuracy, simplified monitoring, and eliminated the need for paper study documents. This also helped sites collect data more easily and it streamlined screening and patient visits.

To make things even easier for sites, our electronic Lupus Disease Assessment Suite (eLAS) included pre-programmed workflows and study processes that gave reminders, calculated data, and provided training and other study-related information. The platform can walk site personnel through each test and assessment and provide guidance and context for the proper completion of this information. For research-naïve sites, these functions were especially helpful.

eLAS is uniquely structured so that the completion of the physical assessment drives data through the required organ specific sections of the protocol-required questionnaires, using over 6,500 data connections. Our platform consolidates this data into reports that are immediately available to all study team members. This saved our CRO partner time by eliminating the need to transcribe data from paper into an electronic format. It also streamlined the once cumbersome adjudication process by providing real-time access to the study data.  

Changing Obstacles to Opportunities

Using the eLAS platform, sites streamlined their workload and even reduced or eliminated some tasks, saving both time and money. We also improved study efficiency and protocol adherence, making regulatory lapses less likely to occur. The improved data accuracy made monitoring more efficient and ensured that study endpoints were met.

During the initial build and trial run, we worked side by side with the CRO to obtain valuable feedback from study teams and site personnel, which we then used to improve the functionality and usability of the platform.

Through this partnership, we eventually deployed eLAS across multiple lupus studies. By simplifying lupus clinical trials and making them more efficient to conduct, there is greater potential for better treatments to become available to help people living with lupus.

And, while this was a one-of-a-kind, scalable solution specifically built for lupus research, the experience we gained now makes other therapeutic-specific clinical trial solutions possible.

[1] Lupus Foundation of America. Common symptoms of lupus. https://www.lupus.org/resources/common-symptoms-of-lupus. Accessed July 18, 2019

[2] Lupus Foundation of America. Lupus facts and statistics. https://www.lupus.org/resources/lupus-facts-and-statistics. Accessed July 18, 2019.

[3] Lupus Foundation of America. What is lupus? https://www.lupus.org/resources/what-is-lupus. Accessed July 18, 2019.

Topics: Lupus

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