Many clinical trials test treatments or drugs that may cause harm to participants. Even when using well known and common treatments, safety is still an important consideration. For example, combining two existing treatments or drugs together, or using a known drug in a different way or in a different population, may have different effects. 

Robust systems are required to ensure all relevant side-effects (known as adverse events {new Glossary definition of adverse events} are detected, recorded and reported in accordance with the protocol and any relevant policy and legislation.

The Therapeutic Goods Administration (TGA) must be notified of any Suspected Unexpected Serious Adverse Reaction (SUSAR) that occur during a clinical trial. NSW Health has a notification form for SUSAR. To ensure adequate oversight of safety, consider establishing an independent committee to review safety data and monitor serious adverse events.

Safety monitoring and reporting is necessary for all trials involving novel investigational medicinal products or medical devices (referred to as therapeutic goods).

The HREC will review your plans for safety monitoring to ensure adequate arrangements are in place to monitor the safety of participants during the trial. Information could include details of what interim results will be monitored and when analyses will be completed, who will review interim results, and what guidelines will be followed for modification or termination of a study. They will also assess how trial risks will be mitigated and managed.

• Have you considered how people in your clinical trial will interact with the healthcare system, particularly if they are experiencing an Adverse Event?
• Make sure your participant communications include information on adverse events and what to do if they think they have had one.

Who can help?

• The NHMRC provides guidance on safety monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials involving investigational medicinal products and investigational medical devices for trials conducted under the Clinical Trial Approval (CTA) or Clinical Trial Notification (CTN) schemes. The Guidance is also broadly applicable to all clinical trials involving therapeutic goods.

• The NHMRC has developed Supplementary Guidanceto provide further advice for non-commercial and commercially sponsored clinical trials involving therapeutic goods. This supplementary guidance covers the following topics:
  • Data Safety Monitoring Boards (DSMBs)
  • Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods.
  • Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods.