Knowledge Center

On Friday, November 15, 2024, the Decentralized Trials & Research Alliance (DTRA) held a fireside chat between Brandon Maggio, GSK’s Global Head of Digital Operations & Process Optimization, and Alison Holland, Medable’s Chief Customer Officer. They were gathered to discuss the evolving landscape of decentralized and digital clinical trials and how best to drive change management in an era of continual changes within trial research. The following blog is a summary of their discussion.

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This year’s Scope Summit once again brought thousands in the clinical research space together, offering a glimpse into the evolving operational and technological landscapes shaping the future of trials.  

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The J.P. Morgan Healthcare Conference returned to San Francisco this year, bringing significant deals and strategic shifts that signal where healthcare is headed. While this year’s weather outside was dry and sunny, a substantial change from the prior two years' rainy conferences, the conditions inside differed, with several companies making waves. 

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A top-10 global pharmaceutical company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites and participants in Japan.

Recognizing Japan’s distinct regulatory, cultural, and logistical landscape, the company partnered with Medable todevelop an initiative to enhance the region’s patient and site experience.

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A top-10 pharmaceutical company was looking to reduce the amount of administrative burden on their clinical trial sites and themselves.  The sponsor sought to find a vendor that could use one eConsent system to manage paper and electronic consent.  Additionally, they sought to use the central eConsent system to populate the clinical trial sites’ IRB and EDC systems,  as well as some internal systems.

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A top-10 pharmaceutical company was looking to standardize the conduct of their diabetic polyneuropathy trials for future use.

Specifically, the client was looking to digitize their paper “body map” forms. These are used by participants to indicate the severity of pain on their bodies. 

Traditionally administered on paper, body map assessments had been a source of potential inefficiencies and errors. 

The client’s goal was to co-create and own their body maps, while simplifying and streamlining the process for future trials.

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Deployment of remote and virtual clinical trial methods and technologies, referred to collectively as decentralized clinical trials (DCTs), represents a profound shift in clinical trial practice. To our knowledge, a comprehensive assessment of the financial net benefits of DCTs has not been conducted

Research looking at mobile apps and how they may provide a meaningful access point for all stakeholders for symptom management.

What is eCOA?

As FDA Principal Deputy Commissioner Janet Woodcock said in a 2015 Clinical Outcome Assessment Public Workshop, “It turns out that what is really bothering the patient and what is really bothering the doctor can be radically different things...patients are true experts in their disease.”

Clinical outcome assessments (COAs) have been key to capturing a comprehensive picture of patient experiences and treatment outcomes in today’s research landscape for decades. Integrating COAs into trial protocols bolsters our treatments' scientific integrity and enhances our ability to understand the real impact of interventions on patients. 

COAs (called eCOAs when captured electronically) are essential to understanding whether a drug reduces symptoms, improves patients’ quality of life, and improves their ability to perform activities they care about. 

Since the mid-2010s, electronic clinical solutions, like eCOA, have rapidly replaced their paper counterparts. Electronic Clinical Outcome Assessments comprise systematized digital methods for capturing patient-centered outcomes in clinical trials. These systems utilize validated electronic interfaces to collect, store, and analyze patient-reported data, clinician observations, and performance metrics.

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From improved patient engagement to streamlined workflows, eCOA is revolutionizing clinical trials. Discover the benefits, challenges, and how sites can overcome hurdles to unlock the full potential of this technology.

Discover how advanced eCOA platforms improve patient adherence, ensuring reliable data and faster trial completion. Explore real-world successes, including adherence rates exceeding 90% in diabetes and oncology studies, powered by Medable’s eCOA (electronic clinical outcomes assessment) solutions.