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Benchmarking Survey: Aggregate Safety Assessment Planning in Clinical Trial Drug Development

Aggregate Safety Assessment Planning in Clinical Trial Drug Development is new, not well understood, and actively evolving. In our 1st survey (https://doi.org/10.1007/s43441-026-01055-2), we could not ask simple questions and expect well-defined answers; so we conducted interviews. Our sample was small (n = 21), but the data from each of the respondents was rich. Now that we understand the key questions and likely answers, we would like to conduct a much larger and more representative survey of the industry with streamlined questions and standardized answers. This will provide a more structured understanding of where the industry is and where it is headed.
1.Name (optional)
2.eMail (optional)
3.Company (optional)
4.Country (optional)
5.Discipline
6.Company size
Anticipated Events:
7.Do you have a different process for reporting Anticipated Events in the US vs ex-US?
8.Do you use standard AE groupings such as OND Custom Medical Queries (OCMQs) and/or Standard MedDRA Queries (SMQs) to define your Anticipated Events and other safety topics of interest (at least sometimes)?
Statistical Group Readiness:
9.Do you have dedicated safety statisticians and/or data scientists?
10.Do your statisticians (some, not necessarily all) have expertise in Aggregate Program-Level Analyses?
11.Do your statisticians (some, not necessarily all) have expertise in Assessments of Safety Topics of Interest?
12.Do your statisticians (some, not necessarily all) have expertise in Graphical Displays?
13.Do your statisticians (some, not necessarily all) have expertise in Interactive Displays?
14.Do your statisticians (some, not necessarily all) have expertise in Blinded Safety Monitoring Procedures (the Trigger Approach)?
Documentation Readiness:
15.Do you use the following program-level safety strategy/planning document: Integrated Summary of Safety (ISS) Statistical Analysis Plan (SAP)?
16.Do you use the following program-level safety strategy/planning document: Program Safety Analysis Plan (PSAP)?
17.Do you use the following program-level safety strategy/planning document: Aggregate Safety Assessment Plan (ASAP)?
18.Do you use the following program-level safety strategy/planning document: Safety Surveillance Plan (SSP)?
Current Operations Readiness:
19.Do you aggregate safety data (at least in some studies) in Phase 3?
20.Do you aggregate safety data (at least in some studies) in Phase 2?
21.Do you aggregate safety data (at least in some studies) in Phase 1?
22.Do you experience the following issue (more than seldom): AE numbers varying among safety documents (for example in the IB versus clinical study reports)?
23.Do you experience the following issue (more than seldom): Desirable safety assessments done in one study but not another (within the same program)?
24.Do you experience the following issue (more than seldom): In late Phase 3, realizing useful safety data were not collected for events of interest?
25.Do you experience the following issue (more than seldom): Various study teams using different approaches to safety data collection and/or analyses (within the same program)?
26.Do you use the following for safety surveillance in ongoing clinical programs (in at least some programs): The Trigger Approach?
27.Do you use the following for safety surveillance in ongoing clinical programs (in at least some programs): A Safety Assessment Entity?
Regulatory Response Readiness:
28.How long has it taken (highest quartile) to respond to safety-related regulatory queries?
29.How disruptive has it been (highest quartile) to respond to regulatory queries?
30.When does an observation stop being routine surveillance and become worthy of systematic aggregate assessment?