BPDCI 23 Jun 2017 Meeting Minutes

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2017-06-23

Agenda

  • Review 'Reasons' for Disposition and Pre-Defined Questions


Attendees

  • Todd Bazin
  • Cathy Bezek
  • Lisa Houterloot
  • Jeannine Hughes
  • Aparna Kulkarni
  • Charity Quick
  • Elizabeth Langevin


Meeting Discussion


Disposition Examples

  • Another team member (company to remain anonymous per request) shared the following Disposition Work Package for discussion:

File:Example of Disposition Standards Sponsor2.docx

  • Based on Examples Provided, Todd Compiled the Following List of Disposition Reasons and Questions for Team:

File:PhUSE BPWG Disposition DRAFT.docx

Disposition Discussion Todd Proposed the following Workflow for Project Team:
Create a use case and define:

  1. Superset of Disposition reasons.
  2. Determine when a Disposition record should be captured (e.g. end of Screening epoch).
  3. 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.
  4. Define the completion instructions that corresponds to each disposition reason.


Generally, the team agreed with the proposal. Elizabeth noted that we need to work together to define a best practice use case (i.e. what we recommend and what regulators require), then obtain feedback from extended PhUSE community and the Regulators themselves (FDA/PMDA), and then revise/finalize white paper.

Much of the discussion focused on WHEN to collect a Disposition Record.
Aparna/Novartis: Recommend only collecting for End of Treatment/End of Study. (Todd noted that this has been Biogen's practice for many years.). Aparna stated we should only collect information required for analysis and regulators. What is neat and pretty doesn't always add value.

Others (Takeda/BI/Astellas) strongly recommended collecting a disposition record after screening and at the end of other epochs such as 30 day follow-up or long term follow-up. It was noted that capturing a disposition record only at 'End of Study' can have limitations. For example: A subject could possibly not complete the screening epoch due to 'withdrawal by subject' and may not necessarily be grouped with a disposition reason of 'Screen Failure'.

Seems we are not going to be able to come to an agreement on exactly when a disposition record is required to be collected. Therefore, Team agreed to take a step back and start with the workflow Todd outlined.

We also need to review the Analysis and Code Sharing White Paper. This team was formed to address the limitations defined by that project team. Their main issue/request was to collect BOTH a reason for treatment discontinuation and reason for study discontinuation. We need to keep this centered as we move forward.

Action Items

  • [All] Verify/obtain authorization to discuss company specific details related to the collection of data.