Unlocking Operational Efficiencies in Reliable Patient Data Collection

This blog was authored by Matt Noble, SVP, Product Management, Patient Cloud at Medidata.

As the clinical trial landscape evolves, efficient and effective patient data collection is critical in understanding the impact of novel treatments. Today’s clinical research professionals are looking to increase efficiency. At the same time, the complexity of clinical trials has increased year-on-year, increasing our expectations for the technologies used throughout the clinical development life cycle. This ongoing evolution highlights the importance of integrating flexible, innovative platforms, forming strategic partnerships, and embracing patient-centric approaches to data collection. 

The Move to eSource

As the volume of clinical trial data rapidly increases, the clinical trial industry, as a whole, is embracing the shift away from paper and double-data entry to enhance accuracy and efficiency. Nowhere has this change been more seismic than in the mainstream adoption of electronic clinical outcome assessments (eCOA).

A recent survey of Electronic Clinical Outcomes Assessment (eCOA) and Electronic Patient-reported Outcomes (ePRO) users indicated that, in the past two years, 53% of clinical trials included an eCOA/ePRO component, a figure expected to rise to 64% in the next two years. Likewise, the use of electronic solutions for collecting patient-reported outcomes (PROs), as opposed to paper-based methods, has risen to 73% and is projected to reach 86% by 2025. The survey also forecasts a significant uptick in the incorporation of sensors and wearables, predicting their usage will rise from 22% to 41% of trials within the next two years¹, demonstrating the industry's rapid shift towards more seamless electronic data collection methods.

As the prototypical “eSource” methodology, eCOA charts a path that Medidata anticipates the vast majority of other clinical data sources will follow. Direct e-source data collection moves the data capture process closer to the patient, the site staff, or the study team, significantly improving reliability and operational efficiency. Our team has found that direct entry of data to, and extraction from, electronic sources, like EDC, resulted in a 60% reduction in data correction, leading to increased speed and significant cost reduction. 

Unleashing the Value of an Integrated Solution

Choosing an eCOA solution that is part of a single platform, both for study teams and, importantly, patients, across the entire clinical trial journey increases the usability of the system and, hence, compliance with study tasks. Additionally, providing a single login experience for sites to manage all their trials, site locations, and remote data collection activities in one place can enable real-time insights into trial status, enabling more productive conversations. When such a platform is further integrated with other clinical trial technologies like EDC, it can not only significantly reduce study timelines but also unlock access to innovative AI tools designed for risk mitigation and enhanced patient insights.

In a recent survey, 47% of users expressed integration with other eClinical technologies (EDC, IRT, etc.) as a desired ePRO/eCOA system improvement. Integration between eCOA/ePRO systems and sensors/wearables, EDC, or eConsent systems was the most mentioned unmet need in decentralized clinical trials (DCTs) cited by 20% of users², underscoring the potential for connected eCOA solutions to enhance data collection processes.

Unified Site Experiences

The same survey indicates that ease of use for sites was most frequently included among users' “Top 5” most important attributes for eCOA/ePRO provider selection³. Choosing a solution that’s part of a broader clinical trial platform, with applications for both patients and sites and familiar workflows across tasks, can increase efficiencies and significantly reduce the burden on sites to manage multiple clinical technologies and login IDs. Tools like the Medidata App can further enhance site experiences and simplify visits by guiding the completion of onsite patient and clinician assessments across trials, leveraging a single app.

Enhancing Patient Engagement 

The only way to build solutions that meet patients' needs is by talking with patients during the technology development lifecycle. Medidata’s Patients Insights group provides iterative input on all of our patient-facing technology, ensuring we create solutions that actually work for patients. For example, having both eConsent and eCOA available on a unified platform leads to a more cohesive trial experience without burdening patients with the need to learn and navigate multiple systems. Additionally, leveraging subjective eCOA data combined with objective validated sensor measures can close evidence gaps and deliver data that comprises a 360-degree view of a patient's experience in a trial.

In fact, in a recent industry survey, 55% of users identified patient ease of use as a factor contributing to the success of eCOA and ePRO trials⁴. Choosing solutions that seamlessly operate together while offering patients flexibility is essential in reducing burden and maintaining engagement across your trial portfolio.

The greater focus on patient enablement highlights the importance of prioritizing a smoother, more intuitive patient experience to maintain a cohesive patient journey when incorporating advanced technologies like sensors and wearables.

Embracing Reusability to Build Speed and Efficiency

Recently, 30% of users referenced startup timelines/platform and build speed as performance attributes with the most impact on eCOA/ePRO trial success. One way to accelerate study build is choosing an eCOA solution that enables access to a global library that contains reusable, pre-configured assessment tools. Reusing study elements can significantly enhance efficiency as each subsequent study becomes more streamlined and processes more scalable.

Committing to Long-Term Partnership

Developing a consistent portfolio of study design processes that leverage the same assessment elements enables more predictable workflows that can help you establish a baseline to glean operational insights over time. Additionally, at scale, this enables a deeper operational oversight into trends across studies such as enrollment and top-level compliance. This allows clients to spot patient, program, and therapeutic area-level challenges early and address them before they become issues. 

Those who commit to long-term partnership and engagement can use these takeaways to continuously inform protocol design choices, including decisions about patient populations, study design, and site selection, leading to portfolio-level quality improvements. Many will recognize the benefits of consistency and reusability as subsequent studies run like a well-oiled machine.

Elevating Patient Data Collection

Adopting these best practices in patient data collection, investing in integrated eCOA solutions, and prioritizing usability are vital for clinical trial success. These flexible approaches not only improve the patient experience but also enhance efficiency with seamless data collection options. 

The newly launched Medidata App is expanding the mobile collection of eSource data through user-friendly apps for both patients and sites.

Download our whitepaper below to learn more about the opportunities and challenges eSource brings to clinical trials as the industry shifts away from traditional, paper-based data sources.

1, 2, 3, 4 Industry Standard Research, 2023