Traditionally, clinical trials have relied heavily on centralized sites and face-to-face interactions between researchers and participants. However, the limitations of this model have become increasingly apparent, especially during the COVID-19 pandemic, which prompted an unprecedented emergence of decentralized clinical trials (DCTs), whose characteristics of remote patient engagement, virtual assessments, and mobile health technologies allowed the healthcare industry to continue drug development (albeit at a slower pace).  As the healthcare landscape continues to evolve, DCTs are emerging as a vital component of the clinical research ecosystem. By leveraging technology and data to streamline processes and the need to enroll a greater diverse patient population, DCTs promise enhanced patient engagement, improved data quality, and accelerated study timelines. As with everything in life, nothing is always that simple. In this blog, we will explore the future of decentralized clinical trials and look at the challenges faced by sponsors, sites, and patients when planning, implementing, and running a DCT. We will also discuss how Medable is continuously adapting its platform and software capabilities to reduce risks and provide solutions that allow the benefits of DCTs listed above to be fully realized. 

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“No one knows their level of pain and how they feel or function better than the patient. Capturing the patient’s response to an electronic Patient Reported Outcome (ePRO) is always the best option.”

Since its inception, Medable has prioritized scientific integrity and rigor around various aspects of clinical trials. As part of its science team, Cindy Howry, VP of eCOA Science, plays a crucial role in ensuring that Medable’s clinical trial platform accurately captures electronic Clinical Outcome Assessments (eCOAs). Hired in 2023, Howry’s chief purpose at Medable is to ensure that the health economics and outcomes research (HEOR) science behind our technology is based on best practices and regulatory guidance.

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The rise of SaaS has transformed industries, including life sciences, by enabling new possibilities. For instance, Salesforce revolutionized how organizations managed their customers and future clients with its cloud-based software, enhancing accessibility and collaboration. Similarly, Canva made graphic design tools accessible to all, empowering professionals and casual users alike.

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With the eConsent market expected to continue its ascent over the next ten years, it’s apparent to those who have used it that the “e” in eConsent stands for much more than electronic.

Analysis and real-world examples show that it can be efficient, educational, and empathetic, leading to better participant education, reduced participant dropout, lower administrative burden for sites, reduced audit findings, and more.

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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.

In today's digital age, Software as a Service (SaaS) has emerged as a cornerstone of cloud computing, transforming how businesses and individuals access and utilize software applications. 

This cloud-based software deployment model has become increasingly popular due to its accessibility, cost-effectiveness, and scalability. Now, SaaS is making significant inroads in the pharmaceutical and life sciences industries, offering solutions to longstanding challenges and driving innovation.

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The adoption of connected devices in clinical trials has experienced a significant surge since 2020.  Driven by the need for more efficient and accurate data collection, sponsors and CROs have begun investing heavily in devices that can help with remote monitoring capabilities and improved patient engagement. These devices, which include wearables, sensors, and mobile apps, are revolutionizing the way clinical trials are conducted, enabling researchers to gather real-time data and gain deeper insights into patient behavior and treatment outcomes.

According to a report by Grand View Research, the global connected device analytics market for the healthcare industry is projected to grow at a staggering compound annual growth rate (CAGR) of 28.9% from 2022 to 2030. This remarkable growth can be attributed to the increasing demand for real-world evidence, the need for remote patient monitoring, and the growing emphasis on value-based care models.

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Modern clinical trials employ various digital-based tools and technologies designed to increase the speed, accuracy, and ease of conducting clinical trials. In the best-case scenario, these tools are housed in the same experience or a  “clinical trial platform.” 

Clinical trial platforms are software-based, web-based, and/or cloud-based solutions that facilitate clinical trial research throughout its entire lifecycle. They offer a complete technology ecosystem that connects patients, research sites, and trial sponsors from patient recruitment to close out and data submission. Users of clinical trial platforms can access and operationalize all of their digital-based tools through this connected platform. Platforms can prevent users from accessing parts of the platform not permitted for them. For instance, participants can not view other participants' data or gain access to tools meant for sites. Other users, like sponsors’ study teams, have access to the full suite of tools as needed based on their roles.