SS P08 14March2016 Standard Scripts Project 08 Meeting

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Meeting Record

When: 14 March 2016
Place: CSS Face-to-Face Meeting
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Terry Walsh, Mercy Navarro, Karolyn Kracht, Sheryl Treichel, Karin LaPann, Lila Thome, Grace Lu, Alan Shapiro, Nhi Beasley, Janet Fan, Xiaoping Zhang, Kendra Worthy, Mary Doi, Eileen Navarro, Vaishali Popat, others that may have been in and out

  1. Medication-related activities
  2. Adverse event white paper topics


  • Eileen Navarro provided a brief update on medication-related activities. The following FDA Notice was issued in March 2015:

FDA Notice.

    • You will see the following statement: FDA is now encouraging sponsors and applicants to provide WHO Drug Dictionary codes for concomitant medication data in investigational studies provided in regulatory submissions (e.g., investigational new drug applications, new drug applications, abbreviated new drug applications, and biologics license applications). The codes should include the drug product trade name where available, the active ingredient(s) and the ATC class.
    • The technical conformance guide (October 2015) has an outline of expectations with respect to medications.
    • We will likely need to update our white paper on demographics, disposition, medications to incorporate this new information.
    • The Controlled Terminology Group at the FDA is interested in receiving feedback on implementation concerns.
  • Adverse Event White Paper
    • Discussed how to display common TEAEs. We proposed a figure in the draft AE white paper. Since the figure is based on MedDRA PTs, there's concern that the putting these in a figure gives it too much attention. Medical would need to see PTs that might be related to the PTs that make the common list. One idea was to use HLT. Another idea was to keep it at the PT level but display it as a table instead (which is what most of us do currently). A third idea was to a priori define what PTs to "consolidate" and use those (along with PTs not consolidated) in the common figure. We need to ponder and continue discussion. Action item (for longer-term): Possibly network with MedDRA about creating a "labeling" level within MedDRA. Mary Nilsson mentioned that she was told by her supervisor that MedDRA was considering it a while back. We might want to encourage it. Need to determine who will follow-up. It appears our FDA representatives have some contacts.
    • Discussed the relatedness assessment by the investigator. We continue to feel that it's not necessary to create a summary that utilizes this assessment. It can still be collected for individual case review. In the CIOMS VI guidance, they recommend only collecting relatedness for SAEs only. That seems to make sense. There is some concern that Japan would expect a summary that utilizes the relatedness assessment. See Japan Guidance. However, it's not real clear. Action item: More follow-up required with Japan colleagues. Need to determine who will do this follow-up. If we do not receive any new information that would suggests it's expected, we will move forward with not including a summary with this assessment.
    • Discussed consolidated terms (also relates to the Common TEAE display discussion). Some of our companies go through an exercise of reviewing all TEAE PTs, then group PTs if it's felt to make sense medically for signal detection and/or labeling purposes, but we tend to go through this exercise at submission time and not for each individual study. Note: This is distinct for "adverse events of special interest (AESI)" where it's quite common to group PTs for a particular medical concept of interest either by using SMQs or creating a specialized group. The consolidated term exercise if more about grouping PTs that might be synonymous and not necessarily an AESI. We talked about whether it would make sense to define these groupings earlier in a compound's lifecycle to use for individual CSRs in addition to the submission. This seemed to make sense, but implementation would be difficult. Discussed possibly following-up with MedDRA about maintaining a level for this purpose. Perhaps HLT can serve this purpose, but it doesn't seem to be exactly what's needed. (Post-meeting note: Maybe lists can be created by therapeutic area via CFAST?) We will continue discussion.

    • Last revision by MaryNilsson,03/21/2016