BPDCI 15 Sep 2017 Meeting Minutes

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2017-09-15

Agenda

1. Disposition Data Collection
a. Any real world descriptions supporting the inclusion of Physician Decision?

2. Medical History Data Collection
a. Collect ALL events or only RELEVANT events?
b. If collect Start/Stop Dates: How should cases be handled if event is ongoing at Screening but resolves during the study? Should Site update stop date on MH form?

3. Pregnancy Data Collection
a. Record as Adverse Event?

4. Adverse Events
a. Collecting all SAEs and AEs after signing ICF?
b. Or collect all SAEs after signing ICF and only AEs after date/time of first study treatment (other events noted between ICF and first treatment recorded on MH)?

Attendees

  • Todd Bazin
  • Aparna Kulkarni
  • Russell Newhouse
  • Jeannine Hughes
  • Sharon Weller


Meeting Discussion

1. Disposition Data Collection
a. Any real world descriptions supporting the inclusion of Physician Decision?
No attendees had an update or were able to pull real-world examples. Continue to discuss. Keep as ongoing action.

2. Medical History Data Collection
a. Collect ALL events or only RELEVANT events?
Sharon noted that Lily collects 'ALL'. Aparna noted that it heavily depends on phase, indication, etc. Jeannine noted that we should be careful to consider baseline characteristics or disease specific history symptoms etc. Much, as usual, is driven by protocol language. Russ noted that usually the protocol states 'significant' MH events etc. No clear recommendation from group.

b. If collect Start/Stop Dates: How should cases be handled if event is ongoing at Screening but resolves during the study? Should Site update stop date on MH form?
Mixed feedback. Aparna noted that we really need to be careful IF we are to recommend updating end date after screening because this would affect the setting of ENREF. If you're not clear, consistent etc. then this could be mapped incorrectly because the meaning of ongoing could be incorrectly interpreted (i.e. ongoing as to when?). Need to control this via metadata (ENREF). Todd stated that Biogen recently concluded that as a company we will not ask sites to update end date after screening (i.e. event status is reported as of screening and not revisited). Action: Todd to draw up general guidance for team's review.

3. Pregnancy Data Collection
a. Record as Adverse Event?
Aparna - just safety database at Novartis. Todd - just safety database at Biogen. Jeannine - just safety database. Russ/Sharon not sure - may be collected as an AE. Action: Follow-up.
Aparna - why does this matter? How does this affect analysis? Action: Todd to check with Mary Nilsson.

4. Adverse Events
a. Collecting all SAEs and AEs after signing ICF?
b. Or collect all SAEs after signing ICF and only AEs after date/time of first study treatment (other events noted between ICF and first treatment recorded on MH)?
Aparna - look at ICH guidance. Aparna noted that, per feedback from Regulatory Agencies, Novartis collects only SAEs for screen failures but for all other subjects ALL AEs and SAEs recorded after ICF! Todd - Biogen collects SAEs after ICF and AEs after first dose. Russ noted Lily records all AEs and SAEs after ICF and uses date of first dose to determine treatment emergence.
Jeannine notes that BI has traditionally collect all AEs/SAEs after ICF but is looking to change policy and only record AEs after treatment (SAEs after ICF), however, BI stuck for reason mentioned above - i.e. what if a study procedure at screening results in an AE? Action: Need to look at ICH guidance.

Action Items

  • [Aparna]Pull real world data for Physician Decision. What free text would justify this option.


Per Aparna email on 11-Oct-2017: Less than 1% (~0.7%) of DSDECOD collected in the DS domain for a Disposition event yielded “PHYSICIAN DECISION”. I must admit that after reviewing responses in the free text field we collect to explain the decision, some of these were related to safety, though most of them were related to administrative reasons such as “subject relocated”. This data was from active studies so could be unclean. We do have a practice to review the responses and query these to ensure site uses the appropriate discontinuation reason.

  • [Todd] Draft general guidance for MH stop date (i.e. update or not update after screening) and what the implications are if you do (i.e. impact on ENREF)
  • [Todd] Check with Mary Nilsson - How does collection of pregnancies affect analysis?


Per Mary N. at Lily: The motivation for me to ask that it be added to your hit list is unrelated to the Standard Analyses and Code Sharing Working Group. The topic of how best to collect pregnancy information came up internally, and I figured it was something that might be best addressed in a cross-industry manner. From a broader perspective, having consistency in how we collect information from pregnancies across industry would be beneficial. It sounds like some researchers might be advocating for a follow-up form of some sort with directed questioning instead of relying on free text in a safety database. However, that would be out-of-scope for your project team. What might be in scope for your project team is to align that it should not be considered an adverse event. So, when you get to the AE instructions, perhaps instructions to not consider pregnancy as an adverse event should be included.

  • [All] Check ICH guidance with regards to the collection of AE/SAEs (i.e. all after ICF signed)?


Per Aparna: No clear guidance. Need to decide on timing. Gain FDA support. Once gain FDA support then also look to align with EMA and PMDA (and other Reg Authorities).