Also known as Medical Events of Special Interest (MESI), are adverse events that are thought to be (potentially) associated with a particular product, group of products (class), or patient population. These events are identified and the list is developed by the Sponsor, in conjunction with external agencies and/or experts in the therapeutic area in which the investigational product is being developed.
“Targeted Medical Events” (TME) is a concept used in pharmacovigilance and clinical research, particularly in the context of drug safety monitoring and assessment. While the term itself might not be universally standardized, the idea behind TMEs is integral to the process of monitoring and evaluating the safety profile of medicinal products.
Concept of Targeted Medical Events
- Definition: TMEs refer to specific medical events or conditions that are of particular interest in the context of a given drug or therapeutic class. These events are usually predefined and are closely monitored throughout the clinical development and post-marketing surveillance of the drug.
- Selection Criteria: The events chosen as TMEs are often those that are known or suspected to be associated with the drug based on preclinical data, previous studies, mechanism of action, or reports from similar drugs in the same class.
Uses of Targeted Medical Events
- Safety Monitoring: In clinical trials, TMEs are monitored rigorously to detect any signals of adverse effects associated with the drug. This involves collecting detailed information about the occurrence of these events in study participants.
- Risk Management: Identifying TMEs helps in developing risk management strategies. If a TME is found to be significantly associated with the drug, measures can be taken to mitigate this risk, such as revising dosing guidelines, patient education, or even re-evaluating the drug’s market availability.
- Regulatory Compliance: Regulatory authorities may require specific monitoring for TMEs as a condition for drug approval, especially if the drug is suspected to have potentially serious side effects.
- Post-Marketing Surveillance: After a drug is approved, TMEs continue to be monitored to assess the drug’s long-term safety profile. This is done through pharmacovigilance activities such as spontaneous report systems, patient registries, and epidemiological studies.
Examples of TMEs
- Cardiovascular Events for Non-Cardiac Drugs: For certain drugs, cardiovascular events like myocardial infarction or stroke may be monitored as TMEs, especially if preclinical data suggests a potential impact on heart function.
- Liver Toxicity: In drugs with a suspected hepatotoxic effect, liver-related events such as elevated liver enzymes or hepatic failure are monitored as TMEs.
- Psychiatric Symptoms in Anti-Epileptics: Some anti-epileptic drugs might be monitored for psychiatric TMEs like depression or suicidal ideation.
Conclusion
The concept of Targeted Medical Events is crucial in ensuring the safety and efficacy of drugs. By focusing on specific, predefined medical events, healthcare professionals and regulatory bodies can more effectively monitor and respond to potential drug safety issues, ultimately enhancing patient care and safety.