A clinical outcome assessment (COA) directly or indirectly measures how patients feel or function and can be used to determine whether or not a drug has been demonstrated to provide a treatment benefit. COAs can also measure a safety benefit (e.g., fewer side effects) compared to other treatments. COA qualification is based on a review of the evidence to support the conclusion that the COA is a well-defined and reliable assessment for use in adequate and well-controlled investigations. FDA qualifies a COA as a measure of a specific concept in a specific context of use, (such as “defining” a clinical outcome assessment (COA), COA “Qualification”, “Content of Use” (COU), “Content of- Interest (COI).

CLINICAL OUTCOME ASSESSMENT QUALIFICATION PROGRAM

DEFINING A CLINICAL OUTCOME ASSESSMENT (COA): Clinical outcome assessments (COAs) measure a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions. COAs can be used to determine whether or not a drug has been demonstrated to provide treatment benefit. Treatment benefit can also be defined in terms of a safety benefit compared to other treatments. A conclusion of treatment benefit is described in labeling in terms of the concept of interest (COI), the thing measured by the COA.

COAs considered for qualification include only those intended to support primary or secondary endpoints. [Note that measures supporting exploratory endpoints or not used to assess the impact of treatment (e.g., for population stratification or for diagnostic purposes) are not eligible for COA qualification at this time.]

In which, the software system (SAS), that we utilize allows us to integrate data, data management, formatted data collection, and well-documented methods for scoring, analysis, and interpretation of results in the targeted patient population. COAs can measure treatment benefit directly or indirectly through single point of control for managing resources that are used in the Enterprise Resource Platform. We also, operate a HIPAA compliant portal with a double-redundancy backup system, to secure all sensitive and confidential data. We have created an easy- to- use dashboard to navigate, access and view data in our web portal. All research efforts are managed with MDataRx’s proprietary and HIPAA compliant Enterprise Resource Platform to ensure private and secure data warehousing, collaborative research efforts and efficient product development.

COA QUALIFICATION: COA qualification is based on a review of the evidence to support the conclusion that the COA is a well-defined and reliable assessment of a specified COI for use in adequate and well-controlled (A&WC) studies in a specified context of use (COU). COA qualification represents a conclusion that within the stated COU, results of assessment can be relied upon to measure a specific concept and have a specific interpretation and application in drug development and regulatory decision-making and labeling. For COAs that do not provide evidence of how patients feel, or function in daily life, qualification also includes a review of the evidence that the concept assessed is an adequate replacement for how patients feel or function in daily life.

A COA is composed of a measure that produces a score plus clearly defined methods and instructions for administration or responding, a standard format for data collection, and well-documented methods for scoring, analysis, and interpretation of results in the targeted patient population. COAs can measure treatment benefit directly or indirectly. For COAs that measure treatment benefit indirectly, qualification also includes a review of the evidence that the concept assessed is an adequate replacement for how patients feel or function in daily life.