Understand how patient safety is monitored in clinical trials.
Recognize key pharmacovigilance terminology related to various types of adverse events.
Pharmacovigilance (PV)
Definition: The science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any drug-related problems.
Importance of Pharmacovigilance
Protects participants and ensures that the benefits of the study outweigh the risks.
ICH GCP principles emphasize that the rights, safety, and well-being of trial subjects take precedence over the interests of science and society.
Safety in Clinical Trials
Continuous safety monitoring is a critical part of all clinical trial stages:
Planned during setup: Risk assessment, pharmacovigilance protocols, and safety management plans.
Involves continuous monitoring throughout recruitment, treatment, and follow-up phases.
Ongoing Safety Monitoring of Participants
Initiating safety monitoring includes:
Collecting baseline health status data of participants.
Conducting health-related inquiries at each patient visit, including questions about concomitant medications.
Recording and reporting all untoward medical occurrences as outlined in the protocol:
Accurate and timely reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs).
Pharmacovigilance Terminology
Key Criteria for Classifying Safety Events:
Seriousness: Assess if the event is serious and related to the trial treatment.
Causality: Evaluates whether the event is expected or unexpected.
Definitions of Adverse Events
Adverse Event (AE): Any untoward medical event that occurs in a participant during a clinical trial.
Adverse Reaction (AR): A suspected causal link between the trial treatment and the event, as judged by the Principal Investigator (PI).
Serious Adverse Event (SAE): An AE meeting seriousness criteria such as:
Results in death
Life-threatening at the time of the event
Requires hospitalization or prolongation of existing hospitalization
Results in significant disability or incapacity
Causes congenital anomalies or birth defects.
Serious Adverse Reaction (SAR): An AR satisfying seriousness criteria and related to the drug.
Seriousness vs Severity
Seriousness is not the same as severity:
Example: Headaches can be severe but may not qualify as SAEs.
Cardiovascular issues would be considered SAEs, but severity can be classified as mild, moderate, or severe.
Definitions Continued
Suspected Unexpected Serious Adverse Reaction (SUSAR): A serious adverse reaction deemed unexpected due to nature or severity not aligning with reference safety data for the Investigational Medicinal Product (IMP).
Reference Safety Information (RSI)
RSI: A list detailing expected medical events for the IMP used, referenced in the trial protocol.
Expected events do not necessitate expedited reporting and are included in Annual Reports (like DSUR).
SAE Reporting Procedures
Defined procedures within trial protocols.
Investigators must report SAEs/SARs/SUSARs to the Sponsor within 1 working day, using a specific SAE form.
Events are reviewed by qualified personnel upon request.
SUSAR Expedited Reporting
Sponsors (or designated responsible persons) must report:
Fatal/life-threatening SUSARs within 7 days of awareness (with relevant follow-up sent in an additional 8 days).
All other SUSARs within 15 days of awareness.
Safety Reporting Procedures
Sponsors (or delegates) complete an annual reporting exercise called a Developmental Safety Update Report (DSUR).
Findings affecting participant safety must be reported to investigators, stakeholders, and oversight committees, including expedited SUSAR reporting to competent authorities and ethics committees.
Key Messages on Safety
Safety management needs to be integrated from trial setup.
Continuous monitoring for safety throughout the trial is essential.
Safety monitoring and management processes can evolve based on new information.
Clear roles and responsibilities must be defined for all involved.
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