As we’ve written about before, clinical outcome assessments (COAs) are designed to capture how a patient functions, feels, and survives in order to better understand the benefits that a new treatment offers. Of the four types of COAs, one is reported directly by the clinician. Known as a clinician reported outcome (ClinRO) assessment, it has a critical role to play in the assessment of treatments in clinical trials. Read on to learn more about ClinROs, why they are important, the industry governance around them, and how their electronic versions can benefit clinical trials.
What are clinician reported outcomes (ClinROs)?
As mentioned above, ClinROs are one of the four types of COAs, the other three being patient reported outcomes (PROs), observer reported outcomes (ObsRO), and performance outcomes (PerfO). Each COA has a specific measurement that adds unique understanding around the impact of a treatment on a patient.
A ClinRO is reported directly by a clinician or healthcare practitioner (HCP) after observing and/or interacting with a patient.
Proper use of ClinROs is critical both for regulatory approval and to provide evidence that a new intervention should be used in clinical practice and covered by payers. Thankfully, the use of COAs, such as ClinROs, is well-established, with clear direction now available from regulatory bodies like the FDA, which even provides an example showing how to properly integrate ClinROs into a clinical trial.
In addition, the ISPOR Clinical Outcomes Assessment—Emerging Good Practices for Outcomes Research Task Force provides an overview of ClinRO assessments. Their report defines three types of ClinRO assessments, including readings, ratings, and clinician global assessments, and provides helpful details as to the current good measurement practices in their development and evaluation.
How remote ClinROs can benefit clinical trials
Historically, ClinROs had to be reported with paper and pencil, and required clinicians to meet with participants onsite, which could create a challenging situation from a logistics standpoint. However, ClinROs, along with all four types of COAs, can now be captured electronically. Electronic COAs, known as eCOAs, include eClinROs, ePROs, eObsROs, and ePerfOs.
Although eClinROs can still be captured onsite electronically, there is a lot of momentum in the industry toward the remote capture of eClinROs via phone, tablet, or computer, which doesn’t require the clinician and patient to be onsite together.
A few benefits of eClinROs include:
Site Workflow Efficiency and Enhanced User Experience:
The ability to automate workflows and create easy-to-follow on-screen instructions helps ensure a smooth clinical trial process.
Reduced Site Burden
As eClinROs can be captured from anywhere with the use of remote technology such as telehealth, sites will see less foot traffic and reduced administrative challenges, significantly easing the burden on site staff.
Improved Data Integrity
According to the FDA and EMA, the use of eCOAs, like eClinROs, can improve data integrity through the elimination of manual data entry, alarm/reminder capabilities, and time and date stamp for entries, among other reasons.