Understanding SUSAR in Clinical Research

General
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1

In clinical research, patient safety is the top priority. One critical concept every healthcare professional should know is SUSAR - Suspected Unexpected Serious Adverse Reaction.

What does it mean?

  • Suspected: There’s a reasonable possibility the reactions is linked to the investigational drugs.
  • Unexpected: The nature or severity of the reaction is not consistent with the product’s existing safety information
  • Serious: The reaction results in outcomes like death, life-threatening events, prolong hospitalization, disability, or cognitive anomalies.

Why are SUSAR important?

  • They are red flags for potential safety concerns.
  • Require immediate reporting to regulators, ethics committees, and investigators
  • Help protect participants and ensure ethical conduct in clinical trials.

Example
If a trial participant develops a sudden, severe cardiac arrhythmia after receiving a study drug (and it’s not a listed side effect), this could be classified as a SUSAR.

Detecting and reporting SUSARs quickly helps safeguard participants, improve drug safety profiles, and uphold the integrity of clinical research.

If you know more, please share your knowledge in the comment section.

MBH/PS

3 Likes
2

Thanks for sharing. Very informative

3

New to me thanks for the information

4

Well put, one more point worth adding is that SUSARs often trigger amendments to trial protocols or investigator brochures.

5

Great topic, SUSAR (Suspected Unexpected Serious Adverse Reaction) is a serious drug reaction not previously known and must be reported quickly within 7 days if life-threatening or 15 days otherwise. Timely reporting is key to protecting participants and ensuring trial safety.

6

Thank you for this explanation. Clear understanding about early detection and safety reporting is very important for anyone and everyone entering clinical research.