Enabling Easier Adverse Event Reporting and Concomitant Medication Collection During Oncology Clinical Trials

Many clinical trials today are still using paper to collect data. Over this 5-part blog series, we’ll examine some of the common challenges with data collection during oncology trials today and explore how you can overcome these challenges. Check back on the following dates to read the blogs in this 5-part series!

The importance of adverse event reporting and concomitant medication collection in oncology trials

An adverse event in a clinical trial is defined by the FDA as "any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related."

Reporting adverse events and concomitant medication are both very important in an oncology trial. Because oncology patients are typically very ill and experiencing significant symptoms as a result of their medications and treatments, it is important that adverse events be considered during a trial as participation can have a major impact on their overall health.

Many symptoms such as mucositis, fatigue, pain, dysphagia, and nausea are often under-reported by clinicians.1 If an adverse event happens at home, in between site visits, or is perceived as a natural side effect of the patient’s condition, it could go unrecorded and that data could be completely excluded from the trial.

It’s also important to consider concomitant medication (ConMed) usage during a trial, which can provide symptom relief that many cancer patients desire. Tracking these medications during a clinical trial can be as important as tracking the treatment being studied. Asking a patient to write down the supplemental medications they take can be difficult; they may not always remember what they take, how often they take it, or what its proper name is (different countries sometimes call the same medicines by different names). Traditionally, this has been recorded in an EDC system by the investigator, which means that the patient is asked about concomitant medication during site visits. It can be difficult for patients to remember what medication they took by the time of their next site visit, which can be weeks after medication intake. These struggles can clearly lead to missed data and incorrect information.

How eCOA helps with adverse event reporting and concomitant medication collection

Streamlined adverse event reporting

Adverse event reporting can interpret adverse event data from such questionnaires as the PRO-CTCAE. PRO-CTCAE, a patient-reported outcome measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials,2 can be incorporated into the eCOA solution to make reporting adverse events simple. With clinicians often failing to report adverse events, growing evidence suggests that these events are best captured directly from patients.1 eCOA solutions support this with their ability to capture symptom data from which the investigator can interpret adverse events.

Easier concomitant medication capture

eCOA solutions support proper ConMed capturing by offering a predefined, personalized list of medications to choose from, as well as the ability to nickname medications for easier patient tracking. eCOA solutions also allow patients to see what they reported and when, the ability to search for a medication in their list, and edit existing medications that they selected.

Collecting this information on an eDiary alongside other study questionnaires means that the patient can report ConMed intake on the same day, resulting in more accurate and reliable data. The investigator can then review the information during the visit and add any missing details such as the correct dosing.

Learn more about electronic adverse event reporting and concomitant medication collection

Sites looking to better capture adverse events and concomitant medication can reach out to us for more information by clicking here.



1. http://www.focr.org/sites/default/files/FINAL%20PRO-CTCAE%20pre-conference%20draft.pdf 

2. https://healthcaredelivery.cancer.gov/pro-ctcae/measurement.html

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