If you need support in pharmacovigilance activities for your profit or non profit clinical trials, do not hesitate to contact us at our Pharmacovigilance Department PV@clinopshub.com, we will guarantee you a reliable, high-quality, and tailored service.
Pharmacovigilance plays a pivotal role in safeguarding patient safety during the clinical development of Investigational Medicinal Products (IMPs). In the pre-marketing context this process involves rigorous monitoring and management of Adverse Events (AEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs).
These activities ensure that potential risks are identified and mitigated before a drug reaches the broader market.
Adverse events during clinical trials are defined as any unfavorable medical occurrences in participants administered an IMP, regardless of causality. These events range from minor symptoms to Serious Adverse Events (SAEs) that might lead to death, hospitalization, permanent disability, congenital anomalies or life-threatening conditions. Regulatory frameworks, such as the EU Regulation No. 536/2014, emphasize the need for a harmonized and transparent reporting system. Documents like the Development Safety Update Report (DSUR) provide a standardized mechanism to inform regulatory authorities and ethics committees about a drug’s evolving safety profile: the majority of them, like DSUR and SUSARs, has to be uploaded in the Clinical Trials Information System (CTIS).
Effective pharmacovigilance during clinical trials requires coordinated efforts between Sponsors and Investigators. Investigators are responsible for documenting AEs in clinical trial records and reporting SAEs within specified timelines, typically 24 hours. Sponsors, on the other hand, assess the severity, causality, and expectedness of reported events based on reference documents like the Investigator’s Brochure (IB). When a SUSAR is identified, Sponsors must notify regulatory authorities through systems like EudraVigilance in the EU and ensure transparent communication with Ethics Committees (if applicable).
Clinical trials conducted in double-blind studies represent the unique challenge for pharmacovigilance. Maintaining the study's integrity while ensuring participant safety needs strategic unblinding of individual cases when SUSARs occur. This selective and careful unblinding minimizes bias in data analysis while allowing accurate reporting of safety concerns.
Pharmacovigilance in the pre-marketing stage is definitely essential for protecting participants’ health, and ensuring that only potential safe and effective medicines reach marketing authorization. By adhering to regulatory frameworks and fostering collaboration between stakeholders, the system ensures that emerging risks are promptly addressed, upholding the ethical and scientific integrity of clinical research.
ClinOpsHub, as a CRO registered at AIFA (Italian Competent Authority), can support you for all pharmacovigilance activities.
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