How an eCOA library can reduce your study start up timelines
Introduction
In today’s fast-paced clinical trial landscape, accelerating study start-up while ensuring compliance with regulatory and scientific requirements is crucial. Sponsors are always seeking more efficient ways of working to help them bring drugs to market faster. At study start up there are many ways clinical trial design can be optimised to avoid delays. One way is through access to an electronic clinical outcome assessment (eCOA) library. In this blog we explain what an eCOA library is, its benefits and the requirements for building one. We also share the experiences of an eCOA provider who shortened study start up timelines by creating an eCOA library.
What is an eCOA library?
An eCOA library contains pre-built and pre-approved versions of electronic COAs and their accompanying translations. The library is stored on a central, secure platform for authorised users, which enables the reuse of these materials across studies. This shared access of pre-approved eCOAs leads to substantially simplified workflows and reduced timelines and costs.
Who can build an eCOA library?
An eCOA library can be built by:
- An eCOA platform provider who will make the eCOA library available to their clients
- A sponsor who has their own eCOA platform for use on their own studies
- A sponsor who selects an eCOA platform provider to host an eCOA library for that sponsor’s use only
Benefits of an eCOA Library
An eCOA library allows sponsors to use their resources more efficiently. Timelines are reduced because there is no need to rebuild eCOAs in the platform. Another important advantage of an eCOA library is the cost savings aspect. The original English does not need to undergo repeated screenshot reviews. Access to an eCOA library can also expedite regulatory submissions as the eCOA library is maintained with up-to-date copyright holders’ requirements and approved screenshots. Several steps in eCOA implementation are removed with eCOA library access, as illustrated in the graphic.
How an eCOA provider saved five weeks during study start up
An eCOA provider was under pressure to reduce study start up timelines. They sought support from ICON to implement the eCOAs for sponsor use. The eCOA provider had developed several COAs for 10 studies over the previous 12 months. These eCOAs were distributed on provisioned smartphones. The main COAs were the Hospital Anxiety and Depression Scale questionnaire (HADS), a trial-specific version of the Zarit Burden Interview (ZBI-22) for a sponsor and Neuropathic Pain Symptom Inventory (NPSI).
Mapi Research Trust (MRT) proposed to build an eCOA library to certify and maintain the HADS, trial-specific sponsor version of the ZBI-22 and the NPSI for future use via the eCOA library. This eCOA provider has a sponsor that was re-using a trial specific version of the ZBI-22 and with permission they were able to include this in the eCOA library.
MRT also identified 10 additional COAs and included these in their eCOA library. MRT maintains a list of COAs certified per study with each eCOA provider. Using this list, they identified other COAs that are most frequently implemented by eCOA providers and can be leveraged for eCOA library use.
By creating and maintaining an eCOA library of their 13 COAs, the eCOA provider saved approximately five weeks of screenshot reviews for each COA. The bank of eCOAs in US English were readily available to sponsors for regulatory submissions
How an eCOA library can reduce your study start up timelines
Considerations for building your eCOA library
Many COAs are copyrighted instruments and maintaining their integrity is essential. When migrating from paper version into an electronic format, steps must be taken to protect the COA from unintended changes.
To protect the integrity of an approved library version of a COA, the eCOA platform provider must consider the following areas:
- Limit access to the eCOA library to authorised users
- Protect approved eCOA library version from changes to content and design, even when added to a study
- Maintain an audit trail of all changes: what changes were made, by whom, and when
- Version control of source English and translations
- Maintain updated versions: eCOA libraries must be kept up to date with the current industry best practices and the developer or copyright holders’ requirements for electronic use. It is important that your eCOA library includes a maintenance service where you are informed of any changes and required updates.
Because of the additional work involved in creating and maintaining an eCOA library many companies partner with ICON to develop their libraries in collaboration with the eCOA platform of their choice. By choosing a reliable eCOA library solution, sponsors can focus on other elements of study start up while their service providers maintain their library.
ICON’s eCOA Library service
ICON’s eCOA Library service has access to over 800 COAs through MRT.
There are four components of the ICON eCOA Library service:
- Licensing: COAs distributed by MRT are copyrighted, appropriate licensing permissions are put in place for eCOA Library use.
- Screenshots review and certification of source English version: MRT reviews the electronic versions of each COA added to an eCOA Library.
- Screenshot review of translations: ICON Language Services reviews the translated electronic versions of each COA added to an eCOA library. The reviews are performed at both initial set-up and at re-use on a study level.
- Maintenance: MRT ensures the integrity of the eCOAs in line with the developers’/copyright holders’ requirements and eCOA best practice. MRT informs the eCOA provider of any relevant updates required to the library version of the COA.
Conclusion
Having access to an up-to-date eCOA library can save study start up time from lengthy screenshot reviews. One eCOA provider who worked with ICON was able to shorten their sponsors’ screenshot review step timeline by approximately five weeks. An eCOA library allows sponsors to access up-to-date, copyrighted COAs, while expediting the regulatory submissions process. Before developing an eCOA library, ensure that the copyrighted COAs’ integrity is protected and that they are updated following industry’s best practice.
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