eCOA digitisation: how to optimise licensing & screenshot review for faster turnaround times

Over the past number of years, there has been huge growth in the use of clinical outcome assessments (COAs) in clinical trials. A big driver for this growth is the increasing recognition of how important the patient voice is in clinical trials. 

Traditionally completed on paper, COAs are now increasingly administered in electronic formats. According to the Industry Standard Research (ISR), industry professionals estimate that usage of electronic solutions will increase from 73% today to 86% over the next two years. Yet, COA digitisation is often seen as a complex and lengthy process. 

This blog post presents solutions to help streamline the eCOA licensing & screenshot review process, with the goal of leading to faster turnaround times.

eCOA setup can be complex as there are multiple workstreams, many interdependencies and different points of contacts. 

There is often no global project plan across the various workstreams, with each set of deliverables having their own timelines. This presents challenges for study start-up planning.

With these challenges in mind, Mapi Research Trust has developed best practices to help improve and optimise this process.

1) Early COA Assessment

Early COA Assessment is a review of the proposed COA strategy to identify any operational risks related to implementation.

The COA strategy should be evaluated from different perspectives and workstreams: licensing requirements, production of new translations (if needed), and eCOA design considerations.

Early COA Assessment is key to optimising eCOA setup times. Reviewing the proposed COA strategy early in the lifecycle of study planning provides an opportunity to remove the risk of eCOA being on the critical path, by enabling risk mitigations and workarounds to be considered and put in place.

2) COA License Management 

Obtaining a license for the instruments can be challenging, especially for studies involving multiple instruments and copyright holders. 

For successful COA licensing management, key steps include:

• Planning & Coordination: In a study using instruments from multiple copyright holders, careful planning and coordination is needed, as timelines and requirements for each copyright holder will be different. For multi-language studies, where linguistic validation (LV) is required for an instrument, it's important to coordinate with the assigned Language Service Provider as early as possible so the LV work can be initiated. 
• Licensing & eCOA expertise: Having a good relationship with copyright holders and a working knowledge of their requirements is important; some copyright holders have very specific or strict requirements for electronic use. 
• Early licensing: In our experience, licensing takes up to 6 weeks to complete. Typically, the eCOA system design and any translation work cannot start until the licensing agreements are in place due to copyright requirements, making it important to ensure licensing starts as early as possible to avoid study delays. 
• Negotiate a Master License Agreement (MLA): Negotiating license agreements can take time. Therefore, where possible, having an MLA or annual license in place with copyright holders will deliver efficiency by reducing the lead time for study-specific licensing. 

3) eCOA Project Planning

eCOA implementation involves multiple workstreams, stakeholders and interdependencies.
We recommend mapping out a global project plan, where all the workstreams and interdependencies are listed. Having a global eCOA implementation project plan and a dedicated Project Manager are key to keeping eCOA off the critical path and ensuring a successful end to end eCOA delivery. 

4) eCOA Library

Study start-up can be facilitated and optimised with the creation of an eCOA Library, centralising pre-built and pre-approved versions of eCOAs and their accompanying translations. The objective of this library is to reduce some of the timeline challenges with regards to licensing, translations work, the eCOA build and screenshot reviews. Indeed, once a COA has been built and approved, the source English version and same language versions do not need to be re-built again or go through screenshot reviews. It is readily available for study re-use, thus increasing efficiency for the eCOA implementation. 

With pre-approved screenshots readily available from an eCOA Library, sponsors can efficiently plan regulatory submissions to optimize study start up. 

Moreover, leveraging the use of an eCOA Library ensures the screenshots remain consistent, and are developed according to the current industry best practices and to the copyright holder’s requirements.

The objective of the eCOA screenshot review is to maintain the integrity of the paper COA during the migration to an electronic format. Screenshot reviews are typically performed by the COA distributor/copyright holder, identifying any errors that may impact the COA measurement properties. The eCOA provider must generate new screenshots to be reviewed, until there are no further comments. As rounds of reviews increase, so does the timeline for approval.

In Mapi Research Trust’s experience, a first round of screenshot review can average 9-10 errors per COA, and 32% of our projects required 3 rounds or more of review. Reducing the number of reviews by one round can reduce the timeline for approval by one week or more. 

The most frequent comments relate to wording, spelling, and formatting. During a six-month period, these comments took up nearly 3,000 of the errors we found, which was around 95% of total errors. Approximately 50% of errors are attributed to typos and changes in wording.

Based on this data, we recommend that the following straightforward and simple checks are performed before submitting the screenshots, to optimise the review process:

• Proof-read: Always proof-read your screenshots before sending them for screenshot review.  Copyright holders or distributors can’t approve any screenshots with typos included. 
• Wording changes: Don’t make any wording changes outside of those required for electronic administration. Faithful migration should not involve any other changes to the measure’s wording (i.e., to the item stem, recall period, and response options).  If you do make wording changes to a licensed COA, this requires copyright holder approval.
• Collaboration: We highly recommend that you engage early with the copyright holder or distributor as early as possible.  Check with the copyright holder or license holder around the requirements for electronic implementation.  If you have any doubts around electronic implementation or platform limitations, highlight these in advance to help identify acceptable alternatives. 

C-Path’s eCOA Consortium have published an extensive article around ePRO best practice, which provides a comprehensive set of guidelines for electronic migration and implementation.

Mapi Research Trust offers optimised services to accelerate the eCOA licensing and screenshot review process and ensure a successful digitisation:

• Vendor Platform Checklist: When we work with an eCOA Provider for the first time, they complete a vendor platform checklist.  This document enables us to understand their platform, identify any limitations, and possible alternatives or workarounds. This proactive approach allows us to address potential issues before the screenshot review stage. 
• eBooklets: This guidance outlines exactly how the screens for eCOA should be developed, in line with author requirements and eCOA Best Practices. They lead to quicker approval as it provides both the eCOA provider and Mapi Research Trust the exact requirements for each COA.
• Screenshot Review: Our comments are classified as “Required” or “Recommended”, allowing for a focused approach on ensuring essential changes are prioritised. Although our Recommended comments are not mandatory to follow, their aim is to promote standardisation of eCOA migration across industry. 
• Licensing: Our expert licensing team can manage the licensing for all instruments, both Mapi distributed and non-Mapi distributed. Our centralised licensing experts can help navigate potential challenges, manage the communication between the sponsor and copyright holders as well as mitigating any potential risks. 
• Centralised services: ICON and Mapi Research Trust are in a unique position, offering end-to-end services for eCOA delivery, licensing, screenshot review, linguistic validation, electronic implementation, and eCOA project management.
• eCOA library: Mapi Research Trust distributes over 800 COAs which are available for inclusion in the eCOA Library Service. We can work with sponsors or eCOA providers who want to build an eCOA library.