Addressing the Challenges of eCOA Licensing

Over the past decade, the industry has successfully addressed numerous obstacles slowing the adoption of eCOA. Electronic data capture is now widely acknowledged as a preferable alternative to traditional paper-based methods. After nearly a decade of industry collaboration, recommendations are in place to enable the use of bring your own device (BYOD) ePRO, and regulatory authorities have officially recognized BYOD data as primary endpoints.

It feels like the industry has taken a leap forward. However, little attention has been given to instrument licensing and the associated translations (i.e., linguistic validation) which, arguably, are the eCOA industry’s most significant challenges today. In fact, the licensing process seems to have become more arduous over the past few years, and the resultant delays are a major roadblock to achieving first-patient-in (FPI) milestones.

What can be done to improve the licensing process?

Most COAs were and still are developed on paper, meaning question layout (tables vs. single question per screen) and instructions may have to be modified for electronic screens; ‘circle the answer…’ becomes ‘select the answer…’ and so on. Some instruments are owned by large organizations that have the resources to develop electronic versions and make the necessary changes or develop new instruments in line with the eCOA Consortium recommendations. However, many are individual authors or small groups (e.g., academia) who don’t have the time, resources, or technical background to take this step proactively. They require input into how assessments are displayed and in-depth screen reviews to ensure content validity before providing approval. This is done for every study, vendor, and device. To make matters worse, getting hold of their office is often difficult, so each contact point adds further delay. The result is a lengthy and costly process.

This is not the only cause for delays. Sponsors and vendors often follow their standard procurement process when licensing the questionnaires: qualification, auditing, MSAs, contracting, etc. This can be a lengthy process, and unrealistic expectations for small organizations often add weeks or even months to the process, as authors usually only agree to have a license in place with the sponsor and don’t accept third parties as an intermediary.

Some sponsors and CROs have changed their process for instrument license holders, reducing the time and frustration significantly.

Next comes implementation. Some authors require payment before sharing source files, which adds months due to payment cycles, but the most common delay comes from issues with the source files, such as:

• Source language: Although usually English, this may be a UK, U.S., or Australian variant. This causes delays when the eCOA vendor cannot support the source language variant for the first implementation.
• Paper source formats: Most authors start from paper, so question wording and screen layout must be created from scratch for every study. Although there are standard industry recommendations, authors often want changes.
• Electronic source formats: Where electronic versions exist, they are often provided in an unusable format (hint: PDF should not be considered an electronic format!).

The result is a laborious process where the eCOA is reviewed every time and for every language. A study using five PROs in 20 languages has 100 variants to review, which takes months and is a direct threat to FPI.

Make licensing scalable

The industry must scale the licensing process to make it easier for authors and faster for sponsors and vendors. Instrument authors will undoubtedly need support to help them invest in developing electronic versions and reusable source files. This will remove the need to review instruments for every study and language, or at least reduce it to a single confirmatory review. Licenses are study-by-study, so authors will still need to be available. However, having a pre-agreed standard will reduce ambiguity and make it easier for them to respond to requests and provide final approval for use.

The same approach should also be applied to translations. Managing translations is a highly manual process, but the same PROs and languages are being translated repeatedly. Having instruments ready for electronic implementation, including translations, will make the process scalable and reduce timelines significantly.

The sponsor-vendor process also needs to change. Currently, the licensing process is typically managed by eCOA providers, but vendor selection can be relatively late in the timeline. Beginning licensing activities earlier, for example, alongside CRO selection would mean licensing agreements could be in place ahead of time so the source files are ready to hand over as soon as the eCOA vendor is onboard.

A call for change

Licensing and translations are on the critical path to FPI. The eCOA industry must come together with license owners and sponsors to remove the need for repeated manual processes and implement a scalable, streamlined licensing approach.

Change is never easy; it will require collaboration, investment, and compromise, but the payoff will be immense. License holders will be less burdened, eCOA vendors will have better source data and faster approval process, and sponsors will have one less barrier to achieving FPI milestones.

Watch this conversation between Willie Muehlhausen and Tim Davis as they explore the barriers to rapid ePRO delivery and how a new approach can streamline both technology and operational implementation.

About Willie Muehlhausen

Willie Muehlhausen co-founded SAFIRA in 2021 after spending more than 20 years in the clinical research industry working for CROs and technology companies in Germany, the UK, U.S., and Ireland. He served as the inaugural Vice-Director of the C-Path ePRO Consortium shaping the initial work of the founding members and is an active member in DIA, ISPOR, and DIME research groups.

In recent years, he initiated and directed research on multiple patient-facing technologies (e.g., ePRO / BYOD, wearables, patient burden, fraud detection via machine learning) and co-authored more than 40 publications and two books on electronic Patient-Reported Outcomes. Willie successfully developed multiple product and service lines in the eCOA space, including the first dedicated ePRO Management group within a global CRO. His industry peers have recognized his work by including him in the PharmaVoice100 in 2015 and the CenterWatch Top 20 Innovators in 2018.