Maximizing Opportunities: Leveraging EMA Clinical Trials Regulation for Successful eCOA Studies in the EU
Navigating compliance, streamlining processes, and enhancing research outcomes
Bryan McDowell, M.Sc., M.B.A. – VP, eCOA Science and Consulting at Clario
Valdo Arnera, M.D. – Medical Scientific Advisor and General Manager Geneva Office at Clario
The new EMA Clinical Trials Regulation (CTR) that came into effect at the end of January 2023 had the objective of facilitating large scale clinical trials in the EU, with the aim to increase the number of clinical studies carried out in the region. Using the Clinical Trials Information System (CTIS), sponsors now only need to apply for clinical trial authorization once across the EU, saving time and effort.
An opportunity to accelerate EC submissions
The Q&A document provided by the Query Management Working Group in February of this year has raised some questions, but also provides potential opportunities.
For example, doubt remains about what should be submitted in Part 1 and about the inclusion of patient-facing materials. The original principle behind the need for patient-facing materials to be approved by ethics committees (ECs) is related to ensuring the patient can provide informed consent. The scope of this principle has expanded over the years to include anything that may be patient facing, such as eDiary questionnaires, instruments or screens.
The existing guidelines do not include a specific requirement for the submission of screenshots at any point in the process. There are some references in the Q&A document to what are now considered to be patient-facing materials, and that does include eDiaries but not screenshots. Therefore, there’s an opportunity to put the eDiary content in the protocol. And by doing so, it should accelerate EC submissions as long as the protocol synopsis, which still needs to be translated in many countries, also contains that information.
Reducing uncertainty in the process
However, sponsors and eCOA providers do not know for certain what local ECs will request and why. For the industry to be able to take advantage of the new CTR, harmonization of EC requirements – both within and between countries – is key. The current lack of it is causing confusion, and may potentially create the opposite effect of what the CTR is trying to achieve.
The industry itself can also take action to speed up the EC approval process, most notably by including the ePRO and eDiary details within the protocol and not waiting for screen shots in multiple languages to be available before submission to the ECs. A translation of the protocol synopsis should suffice for EC review and approval of eDiary/ePRO elements. However, an earlier submission does mean that a little more upfront planning is required by sponsors and eCOA providers.
If sponsors and eCOA providers decide to follow this path, we could see a reduction in trial start timelines by several weeks. Furthermore, it might be interesting to understand what other elements of the clinical trial can help facilitate an earlier EC submission.
The industry needs to work together to encourage European EC harmonization to achieve the CTR’s objective without complicating the study start-up process further.
Navigating the regulatory landscape of eCOA and ePRO
Recent regulations from the FDA and EMA are setting transformative directions for electronic clinical outcome assessments and patient-reported outcomes. Clario’s expert webinar provides a deep dive into these regulatory shifts, offering clarity and guidance.
Bryan McDowell, M.Sc., M.B.A.
VP, eCOA Science and Consulting
Valdo Arnera, M.D.
Medical Scientific Advisor and General Manager Geneva Office