Are you keeping up with the rapidly changing clinical trials industry?
19 Jul 2023
6 mins
In a post pandemic world, the adoption of decentralized clinical trials (DCTs) has become increasingly popular. These DCTs are designed to reduce costs, improve data quality, and expand patient participation.
With the rise of DCTs, there has been a surge in the need for electronic clinical outcome assessments (eCOAs) rather than paper COAs. This is because DCTs often rely on patients’ utilization of phones, tablets, and/or computers to complete the eCOAs.
While the shift from paper to electronic-based methodologies has brought about many benefits, it can also add complexity to the translation process for COAs. This is because many paper COAs must be edited to be suitable for electronic format while also abiding by copyright holder regulations and industry best practices to ensure patient understanding. For instance, while it may be correct to circle a response on a paper COA, on an electronic screen, a participant will almost always select the response.
Failure to update instructional text such as this to align with eCOA administration may cause confusion amongst patients and create data collection risks for the clinical trial.
Our innovative response – eCOA Ready Text library
At RWS, we have identified that eCOA implementation is a major struggle when it comes to meeting clinical trial timelines. To make this process easier for all stakeholders, we are delighted to announce the option for our clients to use an eCOA Ready Text Library.
The purpose of this library is to reduce the time it takes to implement instruments in eCOA screens by storing and reusing instruments’ eCOA instructional edits over time.
With countless COAs in existence, many of which have multiple existing versions, starting an eCOA Ready Text Library reduces the complexity of eCOA implementation from the start. Any changes that need to be implemented into the COA to ensure excellent data will be stored for later reuse.
What is eCOA Ready Text?
eCOA Ready Text is electronic wording that has been implemented into a COA, following industry best practices, to ensure patient understanding during electronic administration. Predominantly, these edits are changes to the instructional text of a COA to ensure that it is suitable for use in an electronic format. For example, instructional text containing “circle,” “checkmark,” or “put an X in the box” is changed to “select.”
eCOA Ready translation development
RWS has built our eCOA Ready Text development into our linguistic validation process. This process involves several steps, including, but not limited to, forward translation, reconciliation, backward translation, paper proofreading, cognitive debriefing, and various external reviews (clinician, copyright holder, etc.).
- The forward translation step involves translating the COA from the source language to the target language by two independent translators.
- The reconciliation step involves reconciling the two translations and producing a single, reconciled version of the translation.
- The backward translation step involves translating the reconciled version back to the source language by a third translator who is blind to the source text.
- The paper proofreading step involves reviewing the COA alongside native speakers to ensure a high-quality translation.
- The cognitive debriefing step involves testing the translation with target-language speakers to ensure that the translation is culturally appropriate and understandable for individuals of varying education and age.
- The final step involves reviewing the COA alongside external contacts to ensure that the translation meets all relevant guidelines and standards.
RWS's linguistic validation process is designed to ensure the accuracy, reliability, and validity of COA translations, which is critical for the success of clinical trials. By using the eCOA Ready Text Library and RWS's linguistic validation services, clients can save time and reduce errors in the translation and implementation of COAs.
eCOA Ready Text Library advantages
One of the significant advantages of the eCOA Ready Text Library is that it can help to ensure consistency of eCOA translations across multiple studies. By reusing previously approved eCOA-ready text, clinical research teams can save time and reduce errors. This, in turn, can help to improve the quality of data collected during the study.
Furthermore, the eCOA Ready Text Library can help to reduce the risk of errors and inconsistencies in eCOA implementation. By providing access to pre-approved eCOA-ready text, RWS can reduce the risk of errors and inconsistencies that can occur during the eCOA implementation process – instead of creating new edits on a study-by-study basis, the library enables our team to reuse previous edits, ultimately creating consistent eCOA reports. This can help to ensure that the data collected during the study is accurate, reliable, and of high quality.
Let’s work together
The shift towards electronic-based methodologies in clinical trials has brought with it new challenges for the translation of COAs. However, with the use of an eCOA Ready Text Library, these challenges can be mitigated, allowing for more efficient implementation of instruments across multiple studies.
At RWS, we understand the importance of a well-executed linguistic validation process and have the expertise and experience necessary to guide you through it. Our end-to-end process management, eCOA solutions team, and linguistic validation center of excellence ensure that your translations are done right.
Contact us to learn more about how our team can help you navigate the complexities of linguistic validation and achieve success in your clinical trials. We are always ready to work with you to ensure that your clinical trial runs smoothly and successfully.
Gregory Putlak
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