BPDCI 08 Sep 2017 Meeting Minutes
- Continue to Review 'Reasons' for Disposition.
NOTE: We decided on the following which will frame future discussions on this topic.
Create a use case and define:
- Superset of Disposition reasons.
- Determine when a Disposition record should be captured (e.g. end of Screening epoch).
- Define disposition reasons to include in each disposition record (i.e. create a CRF for each) or at least guidance for which options to consider for each.
- Define the completion instructions that corresponds to each disposition reason.
- Todd Bazin
- Aparna Kulkarni
- Russell Newhouse
- Jeannine Hughes
- Tina Lambert
- Concept of 'Caregiver Circumstances'
Russ explained that Lily implemented the concept 3 years ago at Lily for studies like Alzheimer's.
However, team questions this approach because of the overlap with Withdrawal by Parent/Guardian. A parent/guardian can also be a caregiver. Could you have a study where you collect both 'Withdrawal by parent/guardian' and 'Withdrawal due to Caregiver circumstances'? Team thinks this is confusing.
Agreement to remove caregiver option because ultimately it still comes down to subject OR parent/guardian discontinuation because caregiver wouldn't have the legal right.
Team suggested providing guidance for collecting a caregiver disposition record and mapping to Associated Persons domain.
- Lack of Efficacy
Regarding the addition of sub-reasons (Based on Investigator vs. Subject): Lily had actually discussed adding this in the past. MDs wanted it but regulators didn't care.
(A) Todd to follow-up to determine how this additional sub-option would be used in analysis. Would it truly add value? Would it influence analysis? If no good reason then we should consider removing.
- Protocol Deviation
Decision - team wants to force collection of specify free text.
- Physician Decision
Lily keeps it because of very special cases. They have it at the very bottom to ensure all other options are vetted. Novartis and Lily collect specify free text and review diligently to ensure the response shouldn't map to another option.
- [Aparna]Pull real world data for Physician Decision. What free text would justify this option.
- [Todd] Clean up disposition example (i.e. finalize draft collection use case, put together document detailing when to use options, create eCCGs). Goal is to put disposition package together for review.