One of the primary goals of every clinical trial is to evaluate an intervention's safety and effectiveness to that of a control or other care. As a result, all studies expose participants to risk, and these are risks that may be similar to those they encounter in ordinary clinical practice in many circumstances. It is critical to document instances of injury or poor outcomes that occur during the study to ensure that both expected and unforeseen hazards are identified.
Several phrases are frequently misconstrued as synonyms, including adverse events, adverse drug reactions, adverse effects, serious adverse events, serious adverse effects, side-effects, complications, and damages. When it comes to drug safety, though, both terms are often used interchangeably.
The following are examples of adverse events (AEs):
- A physiological occurrence, such as a rash.
- A psychological occurrence, such as altered cognition.
- An abnormality in the laboratory, such as a high creatinine level.
- Increased severity of a pre-existing ailment, such as uncontrolled blood glucose levels
Documenting and reporting adverse events; especially those events related to the study intervention helps in:
- Informing health authorities, clinical investigators, and others of new and important information about events that occur on a clinical trial
- Contributing to the summary of adverse experiences related to the development the drug, device or regimen toxicity profile
Documenting Adverse Events
All adverse occurrences must be recorded in the medical record of the patient. The study team must first grasp how AEs should be collected before documenting them. To avoid bias in AE collection, patients should not be questioned about specific occurrences that may be expected while on the trial.
AEs should be reported or elicited from a person at each study visit in the following situations:
- during open-ended inquiries
- during examinations
- during evaluations
The collection of AE data begins when the study intervention (drug/procedure) is started. The AE data should be collected from the commencement of a placebo lead-in period or other observational period intended to establish the patient's baseline status. The AEs should be observed until they resolve or stabilize. All AEs that necessitate interruption or termination of the study drug, or those that are present at the end of study treatment, must be followed up on.
Reporting Adverse Events
Clinical trials can be conducted in a single or multi-center setting. Multicenter studies include a larger number and a wider range of research participants, making it more difficult to track adverse events, and certain incomplete safety reports from these multi centers may reduce the overall understanding of the adverse event.
The regulatory authorities must be able to analyze the safety information based on accurate documentation. The severity, study intervention relationship, action taken about the study intervention, adverse event outcomes, and if it was serious should all be documented.
All observed adverse events, as well as all adverse events reported by study participants, must be documented by the investigator. Regardless of the seriousness of the information presented, it should be recorded and reported. This data is saved in the safety database for the medicine or device under evaluation.
Conclusion
Each adverse event must be understood, as well as its relevance and significance to the drug or device being tested. Patient safety is increased as a result of the recording and reporting of these incidents.
Need inspection readiness assistance in your safety department or specialized training in the area of adverse events? Contact us! We’d love to hear from you to discuss strategies!
References
ClinicalTrails.gov. ClinicalTrials.gov. (n.d.). Retrieved June 11, 2022, from https://clinicaltrials.gov/ct2/help/adverse_events_desc#:~:text=Adverse%20Events%20are%20unfavorable%20changes,specified%20period%20following%20the%20trial.
MB;, G. R. E. D. N. A. L. (2014). Registries for evaluating patient outcomes: A user's guide [internet]. National Center for Biotechnology Information. Retrieved June 11, 2022, from https://pubmed.ncbi.nlm.nih.gov/24945055/
What are 'adverse events' and why is it necessary to record and report them? students 4 best evidence tutorials and fundamentals. Students 4 Best Evidence. (2021, March 26). Retrieved June 11, 2022, from https://s4be.cochrane.org/blog/2021/03/26/what-are-adverse-events-and-why-is-it-necessary-to-record-and-report-them/