- Oncology clinical trials (https://voice.ons.org/topic/oncology-clinical-trials)
- Research (https://voice.ons.org/topic/research)
- Patient reported outcomes (PROs) (https://voice.ons.org/topic/patient-reported-outcomes-pros)
- National Cancer Institute (NCI) (https://voice.ons.org/topic/national-cancer-institute-nci)
How Is CTCAE Improving Research and Patient Care?
As reported to Chris Pirschel, Staff Writer, by Shanda Finnigan, MPH, RN, CCRC
The Common Terminology Criteria for Adverse Events (CTCAE) is a list of adverse event (AE) terms most often encountered in oncology. It’s been in ongoing development since the 1980s and was previously referred to as the Common Toxicity Criteria. Through continual development and support from the National Cancer Institute’s (NCI’s) Cancer Therapy Evaluation Program, CTCAE aids in the documentation and analysis of adverse events in oncology-related clinical trials.
Moreover, CTCAE provides a standardized definition for AEs, along with a grading scale that indicates the severity of each event. It uses the Medical Dictionary for Regulatory Activities as its hierarchy and organizational structure.
CTCAE’s goals are as follows:
- Standardize AE reporting within the NCI oncology research community, across groups and modalities.
- Facilitate the evaluation of new cancer therapies, treatment modalities, and supportive measures.
- Aid in AE recognition and severity grading.
- Monitor safety data for reporting to regulatory bodies.
- Define oncology research protocol parameters (e.g., eligibility criteria, dose-limiting toxicity, maximum tolerated dose, dose modification).
Oncology nurse scientists are likely already using part or all of CTCAE in their practice, either in case report forms or through online AE reporting systems. However, CTCAE is also useful at the patient level for all oncology nurses—not just those involved in clinical research. Nurses can use it to better characterize their patients’ cancer experience, so they can inform and prepare future patients with similar diagnosis and treatment.
For example, a patient may be told to expect vomiting after chemotherapy. What does that really mean? Should the person expect to throw up once? Five times? All day? By applying a standardized approach to recording the patient experience, nurses gain a quantifiable level of familiarity with the agent or intervention’s AE profile which, in turn, will help them answer the question of how many times the patient may expect to throw up.
CTCAE provides standards for the description and exchange of safety information in oncology research and nursing. Without standards, clinical research is less effective, because researchers are not able to compare safety information between trials. Furthermore, CTCAE is a cornerstone of patient safety. Having a consistent way to asses a patient’s experience with AEs helps us inform future patients what side effects they can expect from a given intervention, whether it’s chemotherapy, immunotherapy, or any other cancer treatment.
Using a standard like CTCAE improves nursing practice in a couple of ways. Beyond improving our ability to categorize and communicate AEs in ways that benefit patients, it elevates our practice to effectively, concisely, and consistently communicate with other clinicians. CTCAE is an internationally accepted standard for defining and categorizing adverse events. It allows us to talk to our patients in a more useful way, and it also allows us to speak the same language as cutting-edge oncology researchers around the world. It’s one way oncology nurses can show their clinical expertise and advocate for better patient safety and care.