Revolutionizing Study Startups: Unlocking the Potential of eCOA Libraries

This blog was authored by Paul O’Donohoe, Senior Director, eCOA Product and Science and Ines Smajic, Associate Director, Instrument Services at Medidata.

As electronic capture of clinical outcome assessments (eCOA) has gradually become the gold standard method for gaining patient experience insights in clinical research, the emerging conversation around eCOA Libraries represents an industry-wide desire for greater efficiency in study setups. The concept of eCOA Libraries promises significant time savings through the storage of author-approved, pre-built versions of questionnaires and translations—readily accessible by study builders for seamless integration into new trials. Such a repository removes the need to start from scratch each time, reducing author reviews and minimizing localization activities.

Despite these impressive claims, our industry is facing challenges in the journey towards practical implementation of eCOA Libraries.

1. Technology

The first step in delivering a successful eCOA Library solution is having the technical architecture in place that meets the complex requirements for storage and reuse of questionnaires. The system needs to store these files in a way that enables precise control and versioning—a requirement to maintain the integrity of stored assets. It must then allow for the controlled implementation of these assets in new studies while guaranteeing the integrity of the questionnaire or translation.

2. Content

With the technology in place, content is needed to store in the eCOA Library. Instrument authors are protective of their intellectual property (IP). Adding their forms to a third-party library system can feel daunting, often leading to hesitance in embracing this model due to fears of unauthorized use. Working hand-in-hand with instrument owners to negotiate a library license— gaining explicit permission to store and reuse these questionnaires—is essential. Instrument owners often have unique requirements that must be met to obtain this permission; understanding and delivering these distinct needs is the only way to build out the content of an eCOA Library.

3. Operationalizing

Once the technology and content of an eCOA Library are in place, processes are needed to tap into the potential time-savings on offer. It’s vital to make sure that study teams are still executing study-level licensing with instrument owners. Establishing a process that maintains the current status of a questionnaire or translation in the library is crucial, and prevents it from becoming outdated due to an update. Many instrument owners require a report on how many times users pull their questionnaire(s) from a library, and some ask for the ability to audit the content to confirm it’s stored appropriately. Understanding these nuances lets a study team take full advantage of the eCOA Library.

The success of eCOA libraries hinges on a transparent and collaborative approach, where authors feel confident that their rights and contributions are safeguarded within the system.

Trust and accountability play a key role in this relationship; study authors must have full assurance that their unique needs and requirements will be incorporated. By aligning our product and operations teams at Medidata, we can focus on delivering powerful technological solutions, assessing and building around author needs. Our operational team can then work closely with the authors to make sure the implementations of their instruments are being adhered to per their specifications, developing and adapting on the go as needed.

Let’s explore some of the frequent library requirements we’ve seen from instrument authors:

• Functional Integrity: Facilitate proper branching logic and skipping functionality across all modalities (handheld, web, and tablet).
• Consistent Appearance and Layout: Verify that the look and feel of questionnaires are consistent across different modalities.
• Translation Accuracy and Timeliness: At a minimum, maintain the integrity of translated files across reuse. Files may also require future updates to improve translation quality or adapt to changes as languages evolve.
• Update and Version Control: Provide mechanisms for updating and maintaining version control to accommodate author revisions, including records of who is using the instruments and at what point, ensuring no one can unintentionally change a previously approved library implementation
• Legal and Licensing Compliance: Work closely with authors across all components of the legal process, including executing agreements on a per-project basis.
• Education and Communication: Maintain transparent communication with authors and clients, educating them on the requirements and processes involved in using the library effectively.

Continued innovation is crucial to making sure we’re taking full advantage of eCOA tools rather than trying to simply replicate the world of paper forms. Medidata has driven various developments like Designer, myMedidata, and the Medidata App—which seamlessly host and integrate eCOA libraries in the study build—enabling the storage of questionnaires in a way that meets author-specific requirements for control and versioning, allowing for easy deployment in new studies.

Medidata’s legal team, in collaboration with our instrument services Team, has established an intimate understanding of the greater legal landscape around eCOA Libraries. We’ve engaged in productive discussions with instrument owners, and their feedback has deepened our understanding of their concerns and aspirations, enriching our approach to eCOA Libraries. The overall goal is to increase collaboration, drive broader industry discussions on optimizing eCOA libraries, and expedite clinical trials and treatment delivery.

The impact of this technology goes beyond streamlining study setups; the benefits extend to addressing difficult discussions ahead of time that have historically impacted timelines. Proactively driving conversations around instrument requirements means no longer conducting these activities as part of the actual study timeline; the instrument owner will have seen what their questionnaire looks like in the study ecosystem and have already improved and signed off on it.

It’s clear that eCOA libraries offer promising advantages, but realizing their full potential requires overcoming significant technical and legal challenges. It requires a transparent approach involving all stakeholders—developers, researchers, and instrument authors —to create a system that both enhances efficiency and respects the intellectual contributions of its users.

As we move forward, the focus should be on harnessing this technology to accelerate studies

and ultimately improve patient outcomes—an essential goal that all stakeholders can agree on.

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