Correcting course when eCOA endpoint collection runs into trouble
Shadi Zoghi, Vice President – Project Management at Clario
Replacing a critical technology or services vendor during a study, such as an eCOA endpoint provider, is a difficult decision for a sponsor to make. Compounding the additional expense, logistical hassles, and re-training, the pharmaceutical company may lack confidence in the quality and accuracy of the data collected so far. While replacing an endpoint solution can be disruptive, the benefits of revitalizing the trial and having assurance in the quality of the data outweigh the acute challenges.
How did we get here?
eCOA studies go off track for several reasons. While the vendor assures the sponsor that they possess the capabilities and the will to confront any concerns, occasionally a vendor’s inability to perform as expected becomes obvious to stakeholders.
The vendor’s technology may be unreliable or unable to meet technical requirements, or operational problems remain unresolved. Other times vendor personnel do not answer key questions in a timely manner, are unable to solve problems, or lack familiarity with the indication or operational aspects of the trial.
Sometimes the endpoint vendor cannot support the expanded scope required, such as the larger site and patient volumes in later phase trials. Other common reasons for replacing an eCOA provider include limited international capacity or the emergence of logistical problems. These include late delivery of devices to sites, licensing and translation issues, or neglect of regulatory challenges across participating countries. eCOA studies become untenable when the vendor team lacks the ability to solve these issues.
At this point the sponsor realizes that, unless decisive action is taken, the problems may threaten the success of the study.
Identify an eCOA partner to revitalize your trial
It is essential for any potential new eCOA provider to learn the challenges and pain points of the current eCOA solution. One of my guiding principles for rescue studies –which is also true of clinical trials broadly– is ‘focus on the essentials and deliver excellence’. Pay careful attention to the protocol, involve eCOA scientific experts, and propose a study design that is fit-for-purpose.
When an eCOA provider’s scientific advisors, project managers, solutions design analysts, and other roles demonstrate understanding of the identified eCOA endpoints collection and data management elements of a study, that gives the sponsor confidence. For instance, a qualified study team will consider all the ways patients will interact with the eCOA device and foresee the various regulatory, logistics, and translation challenges up front rather than later in the study.
Clear, open and frequent communications are another key step to establishing the vendor a true partner of the pharmaceutical company and/or Clinical Research Organization. The endpoint provider needs to be transparent and aligned with the study team about expectations, timelines, any potential obstacles, as well as actions to remediate.
The way forward with experience and trust
Sponsors expect their vendor not only to address obstacles but also use the experience of its Rescue Study Team members to anticipate and develop plans to avoid data, device, and delivery issues. Clario’s eCOA Study Rescue Team’s pre-award engagement is possible because of our collective experience and knowledge, and we will commit to restoring your confidence in the eCOA data your trial depends on.
Given the higher costs and delayed timeframes involved, there is no margin for inexperience, vague planning, or spotty communications when recovering a study. Expect your eCOA provider’s multi-disciplinary team to offer the scientific and operational guidance that will deliver the critical eCOA data your study needs – data that can be trusted for accuracy, timeliness, and compliance.