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eCOA Clinical Outcomes Assessments

Medical data can save lives. Therefore, Clinical Outcome Assessments are vital tools in research and practice. Clinical outcome assessments measure aspects, such as patients’ symptoms, emotional well-being, cognitive state, and social functioning. Since such tools provide detailed medical information, they can be employed in various professional settings and diseases. It’s not surprising that clinical outcome assessments can be extremely beneficial in clinical trials; for instance, they can be used as indicators of the safety and the effectiveness of new drugs or treatments.

On top of that, as patients are the main participants in medicine – patients’ thoughts, opinions, and observations are vital. Unlike biomarkers or specimen, clinical outcome assessments rely on people’s interpretations. As such, they can reveal impressive insights and hidden information.There are four types of clinical outcome assessments, which are often used by researchers and sponsors in clinical trials. They can be divided into patient-reported outcomes (PROs), clinician-reported outcomes (ClinRos), observer-reported outcomes (ObsRo), and performance outcomes (PerfOs) (“Clinical Outcome Assessment Qualification Program,” 2018).

Clinical outcome assessments are extremely beneficial in research. As explained above, all types of clinical outcome assessments have broad applications in clinical trials and treatment. They provide sensitive information that lab tests may miss.

The type of clinical outcome assessment employed in research depends on the research goal itself and the study design in general (“Clinical Outcome Assessment Qualification Program,” 2018).

Let’s say that a research team may need more information about the actual functional performance on a task. In this case, performance outcomes will be implemented, and patients will be instructed to complete an activity. For instance, a Corsi Block Test can be performed to test patient’s visuospatial working memory.As technology plays a vital role in medicine, electronic clinical outcome assessments have slowly replaced paper formats. They can facilitate research and care, for sure. By employing technology, such as smartphones, researchers can motivate patients to participate in clinical trials. Consequently, this can reduce costs and delays. Most of all, online data collection is precise, quick, and accurate – all that thanks to the numerous digital solutions out there. Technology also makes data storage and access transparent and safe. Last but not the least, electronic forms foster multi-center approach.

In other words, electronic clinical outcome assessments (eCOAs):

Since clinical outcome assessments help researchers improve clinical trials and healthcare practices, these assessments need to meet all the official regulatory requirements. One of the main regulations in research is the popular ALCOA-C. According to ALCOA-C, all medical data should be attributable to its source, legible and easy to read, contemporaneous and credible, original and reliable, accurate and honest, and complete and accessible.

Of course, ethical principles should also be considered, and research should always aim to improve patients’ well-being. Note that survival rates are not the only goal in medicine, but better emotional and social well-being.To sum up, clinical outcome assessments are a vital tool in research and clinical trials. All four types – reported outcomes, clinician-reported outcomes, observer-reported outcomes, and performance outcomes – are extremely valuable, and their implementation depends on the study goals. Yet, regulations should always be a focus of research.

With the powerful role technology plays in medicine, platforms like Qolty can facilitate the implementation of electronic clinical outcome assessments, benefit clinical trials, and improve patients’ lives. Data does save lives.Acaster, S., (2017). Patient-Reported Outcome and Observer-Reported Outcome

Assessment in Rare Disease Trials. Value in Health, 20, p. 856-857.

Clinical Outcome Assessment Qualification Program (2018, January 22). Retrieved from https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm284077.htm

Deshpande, P., Rajan, S., Sudeepthi, L., & Nazir, A. (2011). Patient-reported outcomes: A new era in clinical research. Perspectives in Clinical Research, 2(4), p.137-144.

Powers, J., Patrick, D., Walton, M., Marquis, P., Cano, S., Hibart, J., Isaac, M., Vamvakas, S., Slagle, A., Molsen, E., & Burke, L. (2017). Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force. Value in Health, 20(1), p. 2-14.

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