Podcast
Kirk Shepard
Streamlining Adverse Events Reporting in Oncology: An American Society of Clinical Oncology Research Statement
Summary
Monitoring patient safety during clinical trials is crucial to protect research participants and future patients. Under current regulations for investigational new drugs (INDs), sponsors must report certain serious adverse events (AEs) to the FDA and all participating investigators quickly. This aims to promptly identify and communicate safety concerns.
Despite the importance of AE reporting, stakeholders face several issues:
- Some sponsors send AE reports that do not meet regulatory requirements.
- These reports often lack critical information regarding relevance, causality, and anticipation of the AEs.
- They typically do not include advice or guidance on clinical interpretation and appropriate action.
- This results in researchers, sites, and the FDA being overwhelmed with uninformative AE reports.
- It compromises valid safety signal detection and strains resources for clinical research and FDA reviews.
Monitoring patient safety during clinical trials is critical to protecting research participants from preventable harms as well as protecting patients who will ultimately be treated with an intervention. Under the current regulatory system for investigational new drugs (INDs), sponsors are required to report certain serious adverse events (AEs) that occur during clinical trials to the US Food and Drug Administration (FDA) and all participating investigators through an expedited process. This helps to identify and communicate safety concerns to the appropriate parties as soon as possible.
Despite the critical importance of AE reporting in the drug development process, stakeholders in the system report numerous problems. In the early 2000s, some commercial sponsors of clinical trials began sending AE reports to investigators and to the FDA that do not fulfill the expedited regulatory reporting requirements. These AE reports often lack information on whether the reported AEs are relevant to specific trials, are causally associated with the therapeutic agents being studied, or are anticipated events described in the study protocol or investigator brochure...
oncology, research, reporting, adverse events, clinical trials
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