DELETED Subject Data Story Boards because these are regulatory use cases

Story Board 9. Rolling NDA

Acme Pharmaceutical just conducted its first in man study: Full study data are submitted to FDA within x months of last subject visit. Study data include every data point collected, including all PK parameters. Adverse events are coded using MedDRA version y.z. Later in the year Acme submits the results of a repeated dose study; however, this second study uses MedDRA v. y.z+1 since a new MedDRA release occured in the mean time. As the results of this second study show very strong accumulation of the drug in the liver, accompanied by hefty liver toxicity, Acme decides to stop the development of the drug.

Issues:

• Policy issue, may impact the amount of data to be submitted to the agency. Phase 1 only normally only incorporates the safety data
• Coding issue in that the data may be coded in different versions. 2009-03-12 this is a policy issue, not a message issue.
• There may be a difference in data submission if FDA requests the development be stopped versus the pharma stops development.2009-03-12 this is not a subject data message. But could be in the Study Participation message or in Clinical Trial Registry. Note: refer the issue of closing a study to study participation and Clinical Trial Registration.
• Create a coding story board.2009-03-12 This is not needed because this is a policy issue, not a message issue.

Decision: Drop this story board.

Story Board 11. Diagnose adverse event in a subject

An drug that is marketed in Europe is being evaluated for marketing in the US. A consumer group claims that the drug is associated with a specific adverse event. A reviewer needs to evaluate patients that were treated with the product, and determine if they have experienced the adverse event. This will require the reviewer to evaluate patients that may not have been previously diagnosed as experiencing the adverse event. Planned and unplanned observations and requests for further info (see other use cases)

Issues: One agency asks another agency for additional data. This is not a Subject Data Story Board, this is ICSR. Story board 5 and 6 covers this. These are useful cases but could be colapsed into one with 12 and 13.

Story Board 12. Evaluate AE for Severity

Use Case: A product is known to cause a particular adverse event. Depending upon the severity of the adverse event, the effect of the adverse event on the patient can range from minor discomfort to disability or death. A reviewer needs to determine how many patients experienced the more severe manifestations of the adverse event. Message needs to provide links to the related data that was used to perform assessment of severity. These links would need to be pre-defined. Need to detail when these links are created and under what circumstances Message needs, links, planned + unplanned and request further data as per previous use cases

Story Board 13. Evaluate AE for Causality

Use Case: An drug that is marketed in Europe is being evaluated for marketing in the US. A consumer group claims that the drug causes a specific adverse event. A reviewer needs to evaluate patients that were treated with the product and experienced the adverse event, and determine if these adverse events can be reasonably explained by factors other than the drug, such as high fever, meningitis, treatment with drugs known to cause the adverse event, or pre-existing conditions. In order to determine causality, the reviewer plans to use reasoning similar to that described by Austin Bradford Hill in his paper “The Environment and Disease: Association or Causation (Proceedings of the Royal Society of Medicine, 58 (1965), 295-300.) Similar notes to Case Review 2