With the 14th annual DPHARM® wrapping up, we talked to our peers across the industry to find out what the big themes and takeaways were from this year’s conference.

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There’s no doubt that study launches come with extremely high stakes for sponsors. 

This period requires precise coordination over numerous critical activities across multiple stakeholders, including regulatory bodies, ethics committees, investigator sites, and internal teams. 

Any lapses here can significantly impact the entire study timeline, budget, and, in some cases, the study’s integrity. 

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The landscape of clinical trials is undergoing a significant transformation as digital measures and digital health technologies (DHTs) continue to evolve and prove their worth. 

As of December 2023, approximately 1,550 clinical trials worldwide utilized wearable devices, representing about 2% of all trials. While this percentage may seem small, it marks a steady increase since 2014, and the momentum is set to accelerate.

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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.