Ensuring drug safety: from clinical trials to post-marketing surveillance

Ensuring drug safety: from clinical trials to post-marketing surveillance

Bringing a new drug to market is a long and complex journey, but one thing remains constant at every stage: the need for safety. From the first dose administered in a clinical trial to years after a drug reaches patients worldwide, monitoring for potential risks is critical. Drug safety isn’t just about meeting regulatory requirements – it’s about protecting lives and ensuring that medications provide more benefits than risks.

The role of clinical safety in drug development

Before a drug is approved, it goes through multiple phases of clinical trials to assess its safety and efficacy. Clinical safety monitoring begins with pre-clinical studies and extends throughout clinical development (Phases I–III). During this time, researchers focus on:

• Identifying potential risks early – Pre-clinical safety assessments help determine if a drug is safe enough to be tested in humans.
• Monitoring adverse events – Throughout clinical trials, safety data is collected to identify potential side effects.
• Complying with international safety standards – Organisations like the International Council for Harmonisation (ICH) provide guidelines (such as ICH E2A and E6) for capturing and reporting safety data.
• Detecting safety signals – A key aspect of clinical safety is identifying patterns that may suggest an emerging risk.
• Developing risk management strategies – If potential safety concerns arise, proactive measures must be put in place to mitigate risks.

Why post-marketing safety is just as important

Once a drug is approved and made available to the public, the need for safety monitoring doesn’t stop. In fact, post-marketing surveillance is essential for identifying rare or long-term side effects that may not have appeared in clinical trials. Some key aspects of post-marketing safety (pharmacovigilance) include:

• Tracking real-world adverse events – Healthcare providers and patients report side effects that may not have been evident in trials.
• Detecting new safety signals – Regulatory agencies analyse large-scale data to identify previously unknown risks.
• Updating safety information – Drug labels, product monographs, and risk management plans must be revised as new safety data emerges.
• Conducting post-authorisation studies – Some medications require ongoing safety assessments even after approval.

The evolving landscape of drug safety

As new technologies and data sources emerge, drug safety is becoming more proactive than ever before. Artificial intelligence and big data analytics are now playing a role in detecting adverse events faster, while regulatory agencies worldwide continue to refine safety requirements. Global collaboration is also increasing, with organisations like the FDA, EMA, and WHO working together to ensure medicines remain safe for all patients.

Ensuring drug safety is a shared responsibility among pharmaceutical companies, healthcare providers, regulators, and even patients. By continuously monitoring medications from development to post-marketing, we can reduce risks, improve patient outcomes, and build trust in the medicines we rely on every day.Top of Form

Join our expert speaker, Graeme Ladds on our latest course, Clinical & Post-Marketing Safety, to find out more!

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Published on Jul 22, 2025 by Ella Thomas