BPDCI 01 Dec 2017 Meeting Minutes
- Todd Bazin
- Jeannine Hughes
- Aparna Kulkarni
- Lisa Houterloot
- Tina Lambert
1. CDISC Interchange Update
2. White Paper Status
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).
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We need to draft guidance and get it endorsed.