Analysis of similar events (AOSE)
Analysis of similar events (AOSE)
Analysis of similar events (AOSE)
The sponsor must identify in each IND safety report, all IND safety reports previously submitted to Food and Drug Administration (FDA) concerning a similar suspected adverse reaction and must analyze the significance of the suspected adverse reaction in light of previous, similar reports or any other relevant information.
The Food and Drug Administration (FDA) and the Swiss Health Authority SwissMedic have regulatory reporting requirements requesting an analysis of similar events (AOSE) together with the medical assessment of safety reports submitted to them. This should be an evaluation of the significance of the relevant reported event in the light of previous, similar reports or any other relevant information.
The analysis of similar events (AOSE) should be provided for:
- Suspected Unexpected Serious Adverse Reactions
– Note: The analysis of similar events should also be provided for events other than the primary event when they represent a different medical concept and are also assessed as serious, unexpected/unlisted, and related.
- All serious adverse drug reactions (close monitoring)
- Important events as defined in the clinical trial protocol
- All post-marketing ICSRs originating in Switzerland containing serious unlabelled events
Requirements from the FDA and SwissMedic for compiling an analysis of similar events (AOSE):
- For the FDA, SUSARs from Company-sponsored interventional clinical trials reportable to the FDA
- For the FDA, SUSARs (suspected by the company) from the Investigator sponsored studies that originate outside the USA
- For Swiss Medic, post-marketing ICSRs (including solicited reports) and SUSARs from company sponsored interventional clinical trials originating in Switzerland and reportable to Swiss Medic
Individual case safety reports (ICSR) require analysis of similar events (AOSE):
| Country of origin
|
Type of Study
|
Causality per Investigator
|
Causality per Company
|
AOSE Required or not |
| Any country | Company-sponsored interventional trial | Suspected
|
Suspected
|
Required
|
| Any country | Company-sponsored interventional trial | Suspected
|
Not Suspected
|
Required
|
| USA |
Investigator sponsored studies
|
Suspected
|
Suspected
|
Not required
|
| USA | Investigator sponsored studies
|
Suspected
|
Not Suspected
|
Not required
|
| Countries Other than the USA | Investigator sponsored studies
|
Suspected
|
Suspected
|
Required
|
| Countries Other than the USA | Investigator sponsored studies
|
Suspected
|
Not Suspected
|
Not required
|
The information for similar events is retrieved from monthly cumulative analysis of similar events (AOSE) reports by reviewing the report for relevant MedDRA PTs or synonyms.
During medical review step the analysis of similar events (AOSE) should be compiled based on the data found in the report.
The medical approver should review and confirm the compiled analysis of similar events (AOSE).
Medical judgment should be applied when preparing the analysis of similar events (AOSE).
Note: An aggregate analysis of specific events observed in a clinical trial (such as known consequences of the underlying disease or condition under investigation or other events that commonly occur in the study population independent of drug therapy) that indicates those events occur more frequently in the drug treatment group than in a concurrent or historical control group.
Analysis of Similar Events (AOSE) Template for IND Safety Reports
IND Safety Report
Case Summary
This section will be initiated by a research coordinator and may be modified by principal investigators necessary. The case summary should describe the reported AE in detail, including a description of what happened and a summary of all relevant clinical information (e.g. medical status prior to the event, signs, symptoms, diagnoses, clinical course, treatment, outcome, etc.) The IND safety report should not identify the subject ID #, reporting investigator, or the site as this information may compromise the study blind.
PREVIOUS REPORTS
The information for this section comes from Principal Investigator and the search of similar events. This section should be written by the responsible principal investigator.
* Select one of the following two statements after reviewing the search of similar events results.
Under IND _______(insert IND#), the following IND safety reports of similar AEs have been previously submitted:
| MCN | Reported Event | Submission Date |
Or
Under IND _______ (insert IND#), no IND safety reports of similar AEs have been submitted previously.
In addition to previously submitted IND safety reports of similar events, this section can also summarize pervious serious reports of the same/similar event that were considered unrelated to the investigational product at the time of the reporting. These events would remain blinded, unless a decision to unblind is made by an Independent Monitoring Committee for reasons of subject protection. The decision on what similar events to summarize in this section should be made after reviewing the similar events report generated by Clinical Data Management. If a safety signal is particularly worrisome (e.g., a study stopping type of event), a more extensive evaluation may be required.
Assessment of Relationship
After evaluation the new case report and reviewing any relevant previous reports of similar events, the PI selects one of the following boilerplate conclusion statements, if applicable. The PI may also craft an alternative conclusion.
Based on review of available data, (Insert Institution Name) believes there is a reasonable possibility of a cause-and-effect relationship between administration of _____________(insert study drug name) and the occurrence of _____________( insert AE).
Additional information on risk factors and/or treatment of the AE may be provided if warranted.
Or
Based on review of available data, the (Insert Institution Name) does not believe that there is a reasonable possibility of a cause-and-effect relationship between administration of _______(insert study drug name) and the occurrence of ___________(insert AE).
Explain if warranted. Do not speculate.
Or
Based on review of available data, the (Insert Institution Name) cannot establish or exclude the possibility of a cause-and-effect relationship between administration of __________(insert study drug name) and the occurrence of __________(insert AE).
Explain if warranted. Do not speculate.
After review of the clinical details and investigator’s comments pertaining to this AE, and based on experience to date, the (Insert Institution Name) does not believe that changes to the conduct of this clinical trial are warranted. This statement can be modified if changes to the conduct of the clinical trial are made.
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