Over the last decade, patient-centric drug development and decentralised trials are rapidly becoming the standard approaches for how clinical research companies are running their trials. On one end, we have patients that assume a much more involved role in the design of a trial and in their own health care using technology; on the other end, we have pharmaceutical and biotech companies hungry for more accurate data.
In this patient-focused and data-driven environment, electronic clinical outcome assessments (eCOAs) have become a more widely used strategy to streamline patient data collection, provide real-time access to data (for review and monitoring), enhance patient engagement and improve the integrity and accuracy of clinical studies. However, while the electronic collection of data has many advantages, implementing an electronic approach to data collection, if not managed correctly, can put significant pressure on study startup timelines and end up on the critical path.
Why can eCOA implementation be so challenging?
Proper eCOA implementation requires the coordination of multiple service providers who have deliverables that are dependent on one another. The eCOA implementation requires:
- A service provider to secure license agreements from copyright holders for their permission to use their COA
- A language service provider who can translate COAs using linguistic validation and ensure that the questionnaires are migrated from paper to electronic format correctly and with accurate eCOA-adapted language
- An eCOA vendor who can build a reliable and robust platform according to that specific study protocol
- Most likely, the approval from a copyright holder at different stages of the development process of the electronic versions of the COAs
The key risk in eCOA implementation is the coordination of the deliverables for these service areas. Without coordination, trial startup milestones may be delayed. For example, if patient-facing eCOA material is not ready in time, it may cause delays to ethics submissions, and the first patient can only be enrolled at the site if the eCOA system is ready to collect the data.
What are the keys to a successful eCOA implementation?
The goal is to create a single project plan around the Sponsor’s study milestones led by one eCOA project manager responsible for coordinating the different services and parties. This plan has three critical stages:
1. Gather data for the eCOA plan:
To create a successful project plan, the project manager needs to involve all the stakeholders and gather all the data that will impact the delivery of that project early in the process.
- Define study startup (project) targets (e.g., planned submission dates and site activation dates)
- Understand each service provider’s delivery timelines
- Document any risk and assumptions in relation to the above
2. Create the eCOA implementation plan:
The project plan coordinates each service provider’s milestones in alignment with the Sponsor’s study timelines. All the stakeholders need to collectively review the plan. The plan will highlight at an early stage any downstream risks in eCOA implementation which can be discussed and mitigated at the project outset. For example, the screenshots may not be ready in time for submission, discuss the option of submitting paper-version followed by screenshots, etc. All the parties involved need to be on the same page before moving forward.
3. Execute the plan:
Be prepared that everything discussed so far will likely change significantly, tasks will take longer than expected and study startup targets will shift. Create an eCOA project team with members across the stakeholder groups and apply an agile-like methodology to manage project plan implementation. This can include:
- Regular weekly meetings with the service providers and preferably study startup and clinical leads to review the eCOA implementation plan status
- Discuss changes, create solutions and communicate frequently
- Ensure everyone is always on the same page
Everything happening in the industry and in the world suggests that electronic data collection is here to stay and will play an increasingly important role in clinical trials and drug development. In study startup timelines, every day matters. Therefore, early planning of an eCOA implementation strategy can significantly help stay on track with critical study milestones. Risk assessments around COA use can begin at the protocol design stage, and with a centralised management approach, can be mitigated to keep eCOA off the critical path.
Watch our recent webinar to learn more about important considerations for keeping eCOA off the critical path for clinical trial startups.Watch the webinar