Ed Potero, Senior Manager, Biometrics Operations - eCOA Lead

 

This post is the first in our larger series, Industry Insider Interviews.

YPrime: Tell us about your background as it relates to eCOA

EP: I’ve been involved with eCOA and similar technologies since 2000. I worked for an eCOA provider when eCOA consisted of basic diary and questionnaire scales, and IVR-type of recordings. I had several different roles, including serving on the change control board, and providing oversight of project managers. I also managed implementation of new acquisitions, which involved working across departments to ensure workflow of the new acquisition was successful.

I served as a technical PM at a large CRO where I oversaw (mostly) CNS clinical trials for sponsors and provided front-end project oversight. Within the company’s digital health group, I onboarded new vendors for devices and integrations for eCOA devices.

I joined Biogen in 2017. As a subject matter expert, I work with different groups to standardize eCOA collection across all therapeutic areas. I’m the front-line operational contact for the vendors. I work to promote and enforce best practices, governance, consolidate metrics, and drive process improvement across all the vendors. I also work with clinical teams to be a bridge between data management, biometrics and our clinical team.

YPrime: Can you recall some of the drivers and barriers to eCOA implementation at Biogen?

EP: Mine was the first role dedicated to eCOA. Before I joined, there was an eCOA council, with cross-department representation from every group affected by eCOA. Quarterly meetings would involve clinical, data management, biostats, GHEOR, quality and regulatory, vendor management, and medical groups, among others. Now, the groups meet more frequently, and I ensure that teams are informed about issues, trends, and study status across therapeutic areas as well as keep informed regarding electronic scale availability and CNS experience across our vendors. Until this role was created, some of the teams may have had little knowledge of what scales had been implemented electronically, if there were multiple translations available, or where to locate them.

There are 3 components to our re-launch:

  • New training launched at the end of April, with updated SOPs, WPIs, and process flow. Additionally, this will include role responsibilities and more structure and clarification regarding task ownership.
  • We also instituted a governance structure for the vendors. The governance structure involves quarterly joint meetings where we will discuss the ongoing trials, issues and trends, lessons learned, as well as review vendor KPIs to evaluate performance.
  • I’m also working on a library that will be available for anyone in Biogen to review scales we’ve used across all therapeutic areas (TAs). This will provide a central location for all internal Biogen team members to investigate scale information. We are looking to partner with our vendors to support this rollout.

At the sponsor level, communication can be a challenge, especially with large companies. I am able to leverage experience from previous organizations to bridge communications across the various therapeutic area teams within Biogen to help drive best-practice and be a visible SME to the organization.

Another possible challenge is getting vendors on-board early enough. Typically, when contracts and proposals are done, it comes up right against the build cycle, which doesn’t always line up with first site activated or first patient in. As we move up the contract lifecycle, it will help teams meet the build lifecycle expectations from the vendor.

YPrime: What type of misconceptions about eCOA implementation have you experienced?

EP: The most common I used to hear is the idea that you can only submit electronic screenshots to IRBs and ECs. Submission of electronic versions are by far the best way to go, but you are not always required to submit them vs. paper versions, especially if in a time-crunch. When you’re looking to have the electronic screen shots ready for IRB/EC submission, and you have “X’ number of weeks to get the build implemented with the vendor, the timelines don’t always marry up. You can submit paper, if all the assessment questions are available as well as the instructional text that will be on your device, whether it’s a handheld or tablet. You can save a few weeks this way, which are generally appreciated because timing is usually tight.

Another misconception relates to the need for cognitive debriefing/usability testing and linguistic validation. Both essential yet incur increased cost and time to build into the implementation cycle.

YPrime: How has your experience on the provider side informed how you select and manage eCOA providers now?

EP: Certain things always stay in the back of my mind, and I know what to look for during the study build, based on my experience with vendors throughout the years. Vendor ability to provide a visio review of screen layout, branching-logic, and verbiage revisions is essential to a productive design meeting from week to week in order to meet final release timelines.

Another tool I require vendors to utilize is like a project plan, but it’s closer to a scale management plan. This tracking tool enables review of critical milestones related to electronic scale implementation and enables study teams to stay informed related to potential delays at weekly vendor meetings.

YPrime: What do you see as the biggest opportunities for eCOA in the future?

EP: It’s definitely digital health. There are so many different apps and wearables that can be integrated with eCOA, especially ePRO devices to track certain biomarkers. The basics like sleep and walking are good, but you’re not going to submit a label for them. The combination of ePRO and the ability to measure biomarkers at home is how things are shifting now. ePRO will remain integral, but it won’t be the sole measure. The complement of the two measures is really where the future opportunities lie.