BPDCI 01 Dec 2017 Meeting Minutes

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  • Todd Bazin
  • Jeannine Hughes
  • Aparna Kulkarni
  • Lisa Houterloot
  • Tina Lambert


1. CDISC Interchange Update
2. White Paper Status
3. Medications
a. Collect ALL medications vs. subset (e.g., only medications identified by prior experience/analysis as having a potential impact on the study outcomes).
b. When to collect dose/units?
4. Adverse Events
a. Collecting all SAEs and AEs after signing ICF?
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)? 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).

Meeting Discussion

Medication Questions: Aparna noted that it you may collect more information (additional details) for a defined subset of medications, however, COLLECT ALL MEDS/Treatments. Agreement to collect ALL medications as a general rule - important for safety as well.

Dose/Units: Difficult with multi-ingredient medications.

Phase I: Collect all medications. Phase II/III: More likely to collect more information for a subset of medications. Example: Collect pharmaceutical strength for subset of meds.

Adverse Event Questions:
All AEs after ICF? Or only SAEs?
Look at ICH E6 vs. E2

Aparna noted that Novartis, due to feedback from EMA in 2010/2011, started collecting AEs after ICF.
Industry papers have been drafted on this topic but not endorsed by any regulators.
We need to draft guidance and get it endorsed.

Action Items