Dr. Oakley-Girvan received her Ph.D. from the Stanford University School of Medicine and her M.P.H. from Tulane University School of Public.
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What do patient’s care about most and what do clinicians consider essential to assess regarding their patient’s health and wellbeing while participating in clinical trials? These are commonly referred to as clinical outcome assessments (COAs).
The four categories of COA
In patient-centric clinical trials, COAs are essential to understand the impacts of a drug on certain endpoints, for example, whether it is improving or diminishing quality of life and everyday activities that matter to patients. The FDA, signaling the importance of COAs and the need to develop additional ones, has even created specific guidance and pathways for their development and validation.
Fortunately, one of the lessons from COVID-19 is that we can be flexible and efficient and conduct a multitude of COAs remotely, or what we call eCOAs. No longer do patients need to come into the clinic for every assessment:
ClinROs can be measured over a televisit
PROs can be measured through patient directed surveys on a mobile app
ObsROs can be measured on mobile apps with care partners assistance at home
And device data can be used to generate PerfOs
Not only can we collect these at standard times as if patients were “in clinic” but we can collect them even more frequently adding critical new data to better assess health related quality of life impacts that patients often highly value. If the most important thing to a patient is being able to remain mobile, feel less foggy or fatigued, we can incorporate additional time points to better understand the effects of a trial medication or concomitant meds on outcomes and endpoints.
Furthermore, in many cases longitudinal data collection may be analyzed to monitor participants for simmering adverse events and provide early warning of declining health with which clinical teams can act quickly.
Technology enables this to now be done at scale in a modular fashion which not only helps protect patients but also prevents trial drop out and can encourage retention as patients may feel they are receiving better care.
There is a freedom created by these discoveries and solidification of approach. Patients are no longer tethered to a clinical site, this means patient travel burdens are reduced and distance is of diminishing importance when making a decision to participate or remain in a clinical trial. At the same time, in a decentralized clinical trial model, facilitating remote data capture that occurs at greater frequency in an easily scalable approach will enable statistical assessments that are reliable and allow for new COAs to be developed that can support labeling claims and improved patient health. In sum, the language of eCOAs is a win-win for pharma and patient health.
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