Keeping your AE-Concomitant Medication Associations Clean
Key Findings
Improper or lack of association among Adverse Events (AEs), Concomitant Medications and Medical History post a risk to obtaining a clear study endpoint.
Sponsors should review how the associations are designed, managed and enforce in the study.
Recommendations
Use an EDC system that allows for linkage between AEs and Concomitant medications.
What you Need to Know
When dealing with complex and multiple data associations between AEs and Concomitant Medications many challenges and obstacles can arise when associations are manually managed. Life Science companies can improve data quality by using EDC products with built-in association features.
Introduction
Life Science organizations are always looking for ways to safely accelerate their drug development. The ability to obtain clean data faster is a key to a study’s success.
The Challenge
When dealing with sick patient populations, the list of pre‐study adverse events and concomitant medications can be large. It is critical to understand what new adverse events are generated and how the concomitant medications are related after the subject enrolls and starts the study. However, when so many data points exist, it is possible that intervening medications for the AE are not recorded in the concomitant medication list. Also, for a particular concomitant medication, if an AE association is needed, the process should support the association or highlight when the association is not made.
If a study has 4000 adverse events of which 2000 have an intervening medication listed, we should expect at least 2000 medications in the concomitant medication list, not less. By not addressing this critical association up front, organizations may be left with inadequate information to determine the safety profile of their new product.
Approach
To solve the problem, companies have used the following approach:
Select an EDC system that natively supports the association of AEs with concomitant medications.
Use the EDC system’s native association to perform edit checks for logical integrity within the system. Study specific examples may include:
For an AE form, if “intervention medication” is selected, ensure a concomitant medication is associated.
Ensure the medication start date is on or after the AE start date.
Ensure associated medications have a start date after the patient’s study start date (e.g. consent date).
If a concomitant medication is given for “new condition”, ensure an AE is associated.
Inherent system AE-concomitant medication associations not only allow data to be associated cleanly but also enable the monitoring and data management teams to query and follow up when information is missing or inaccurate. These features assure better data consistency at the study endpoint.
Results
Leveraging the AE and concomitant references and associated edit checks, firms are better able to ensure data is collected properly. This process leads to cleaner data more quickly.
Benefits of the Solution Include:
Eliminates missing data by ensuring medications are associated when medication intervention is specified on the AE form
Speeds data entry
Accelerates data cleaning
Reduces number of queries
Improves data quality by enabling users to make the association of data without a complex and problematic numbering scheme