This blog features:
- Practical aspects of pharmacovigilance in clinical trials
- Why it is important, and
- Key distinctions, with a summary included.
Table of Contents
Introduction
This blog provides a clear understanding of why pharmacovigilance is a crucial aspect of clinical trials throughout the entire product life cycle.
Although pharmacovigilance and clinical trials are distinct domains, both contribute significantly to ensuring drug safety.
Pharmacovigilance plays a continuous role from development through post-marketing, safeguarding public health at every stage.
Overview
Pharmacovigilance is an essential extension of clinical trials.
Being vigilant about the safety of medicines—not just during clinical trials, but in everyday use—is increasingly important due to several factors:
- Overuse of medications
- Polymorbidity (patients with multiple health conditions)
- Accelerated drug approvals
- The growing complexity of treatments and widespread polypharmacy
- Population growth, diversity, and aging
To ensure the effectiveness and continuous improvement of drug availability in the market, pharmacovigilance is vital.
Clinical trials are conducted in controlled environments with limited participant populations. They often do not last long enough to detect rare or long-term adverse events. Therefore, ongoing pharmacovigilance is necessary to monitor safety after a drug reaches the public.
“Pharmacovigilance is the continuous watch that ensures drug safety, guiding clinical trials from controlled testing to real-world use, and protecting public health at every stage.”
Application of Pharmacovigilance in Clinical Trials
Pharmacovigilance during clinical trials is crucial for identifying and managing risks associated with investigational products. It ensures that safety data is continuously evaluated to protect participants and guide decision-making.
Key components include safety monitoring, adverse event reporting, involvement of Data Safety Monitoring Boards (DSMBs), and a clear understanding of both pre-marketing and post-marketing pharmacovigilance.
Pharmacovigilance in clinical trials applies to:
- Authorized and Unauthorized Products – Ensuring safety monitoring for both approved and investigational drugs.
- Pre-Authorization Pharmacovigilance – Focused on detecting and assessing risks during clinical development phases.
- Post-Authorization Pharmacovigilance – Continued safety evaluation after regulatory approval and public use.
- Ongoing Safety Monitoring – Systematic collection and analysis of adverse event data throughout the trial process.
Distinctions
Pharmacovigilance procedures must be applied throughout the entire drug lifecycle—whether the product is already authorized or still under investigation.
For Unauthorized Products, two main scenarios can be identified:
- Clinical Trials – Conducted with the goal of obtaining marketing authorization.
- Compassionate Use – Use of an unapproved product outside clinical trials, typically for patients with serious conditions lacking alternative treatment options.
For Authorized Products, three main use cases can be distinguished:
- Standard Use – According to the approved Summary of Product Characteristics (SmPC).
- Off-Label Use – Use outside the SmPC, such as for a different age group, dosage, or route of administration; though not officially approved, it may still be part of regular clinical practice.
- Use in Clinical Trials – Even authorized drugs may be investigated further in clinical trials, where they are considered Investigational Medicinal Products (IMPs), either as test substances or comparators.
Another critical distinction between clinical trial use and standard use lies in pharmacovigilance reporting requirements:
- Development Safety Update Report (DSUR) / Annual Safety Report (ASR) – Required during clinical trials.
- Periodic Safety Update Report (PSUR) – Required for authorized medicinal products in post-marketing settings.
Summary
To summarize, this topic outlines the key roles of pharmacovigilance across the drug lifecycle:
- Pre-Authorization Pharmacovigilance focuses on evaluating a drug’s safety and efficacy during clinical development. It includes clinical trial monitoring (as per monitoring plans), safety data collection (including AE, SAE, AESI, SUSARs), risk assessment, benefit-risk analysis, and the submission of DSURs or ASRs.
- Post-Authorization Pharmacovigilance involves the ongoing monitoring of a drug’s safety once it is on the market. This includes the reporting of ADRs, SADRs, and UADRs, signal detection, case evaluation, implementation of Risk Management Plans (RMPs), submission of PSURs, and conducting post-marketing surveillance studies.
Key Takeaways
Clinical trials, through various testing phases help identify many potential adverse events associated with a health product, but they cannot capture all possible adverse effects.
Pre-authorization pharmacovigilance is focused on evaluating a drug’s safety and efficacy during its development phase.
Post-authorization pharmacovigilance ensures continuous monitoring of a drug’s safety once it becomes available to the public.
The two approaches generally complement each other, except in the case of spontaneous reporting, where integration between pre- and post-authorization data may be limited.
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Conclusion
This article explained the importance of pharmacovigilance within the clinical trial domain and how it contributes to drug safety, especially considering the limited duration and scope of clinical trials.
It highlights the critical collaboration between clinical research and pharmacovigilance, offering a technical understanding of both areas.
We hope this blog has clarified the key roles and distinctions between pre- and post-authorization pharmacovigilance.
If you notice any important information we’ve missed or have suggestions for improvement, we welcome your feedback and critique.
Please feel free to share this content to help spread awareness about drug safety.
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