Knowledge Center

When talking to customers conducting their first multi-country trial, we sometimes liken clinical trials to spider webs. Just as a garden spider’s web differs from a black widow’s, clinical trials follow unique patterns in every region. Each country comes with its own set of rules, ethical standards, approval processes, and data privacy laws. Cultural factors also play a crucial role in how patients are recruited and understand Clinical trials, requiring sensitive communication and a deep respect for participants’ needs.

In Japan, these regulatory and cultural intricacies form a complex ‘web,’ with anchor points and structural requirements that, when understood and implemented correctly, create a framework for success. However, conducting Clinical trials in Japan has historically posed challenges for Sponsors and Contract Research Organizations (CROs). When we first entered the region, one Sponsor consistently cited issues with eCOA solutions and site and patient support, not fully adapting to Japan’s unique requirements. This feedback, combined with our own experiences on the ground, revealed a clear need for improvement.

Today, we can proudly say that the solutions we put in place have transformed Japan’s Clinical trial landscape, and what was once a challenge has now become the “gold standard” for supporting Clinical trials in the region.

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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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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.

Navigating the complexities of eCOA vendor selection can be tough. This comprehensive guide provides a step-by-step approach, covering everything from vendor evaluation to successful implementation, ensuring your clinical trial's success.

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Electronic clinical outcome assessments (eCOAs) have revolutionized clinical trials, offering significant advantages over traditional paper-based methods. By enhancing data quality, streamlining data collection, improving patient engagement, and enabling real-time data access, eCOAs have become indispensable tools in modern clinical research. However, successful eCOA implementation requires careful planning, meticulous execution, and a deep understanding of the regulatory landscape. This comprehensive guide provides a detailed roadmap for implementing eCOAs effectively, covering key aspects from study design to future trends.

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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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