Minutes 2024-01-05


Joseph Rickert


January 5, 2024

  • Ben Straub (GSK)
  • Dadong Zhang (Illumina)
  • Eva Li
  • Heidi Curinckx (Johnson & Johnson)
  • HyeSoo Cho (FDA)
  • Joseph Rickert (R Consortium)
  • Margaret Wishart
  • Nan Xiao (Merck)
  • Ning Leng (Roche/Genentech)
  • Paul Schuette (FDA)
  • Robert Devine (Johnson & Johnson)
  • Saghir Bashir (Argenx)
  • Sam Parmar (Pfizer)
  • Steven Hasendinckx (Johnson & Johnson)
  • Youn Kyeong Chang

The meeting was recorded and the video is available.

Pilot 3

HyeSoo presented an update on the continuing FDA evaluation of Pilot 3.

  • Using the R generated ADaM data sets, the FDA reviewers were able to replicate the results of the demographic, efficacy, primary and KM plot analyses

  • The reviewers compared the results of the four analyses between Pilot 1 and Pilot 3.

    • Primary output in Pilot 3 was different from the Pilot 1 result due to the QC findings
    • QC findings in ADRG include all of the discrepancies between the original ADaM datasets
    • The discrepancies in ADADAS data sets cause different primary analyses outputs
    • This is an issue from the CDISC ADADAS
    • It is not clear which CDISC file, the file from Pilot 1 or the file from Pilot 3, is correct.

The following figure compares the Pilot 1 and Pilot 3 primary output. Discrepancies are highlighted.

Comparison of Primary outputs Additional FDA questions included:

  • Why is there an indication in the output of LOCF, “Last observation carried forward” when the original data set had no missing data?
  • There was no statistical analysis plan included in the submission.
  • Action: Ben Straub will confer with the Pilot 3 team to answer these questions and review the discrepancy problems between Pilots 1 and 3.
  • Action: Paul and HyeSoo will discuss whether we need to resubmit Pilot 3 The next meeting of the working group will be on Friday, February 2, 2024 at 9AM Pacific Time.
  • All agreed that if a resubmission of Pilot 3 is required, we will consider submitting via a .zip file.

There was some discussion about what we could do to improve the quality control of our submissions.

  • The group agreed that we should have a check list to compare items against a Pilot 1 source of truth.
  • We should have additional reviewers who are not close to the work.
  • The idea of using AI tools to check consistency was mentioned.

Upcoming Webinar

On Monday at 7PM PST Rikimaru Nishimura and Yuki Matsunaga will present a webinar on The Adoption of R in Japan’s Pharma Industry Confirmation. Look here for details and information on how to register.

  • Ning noted that Yuki expressed an interest in collaborating with the R Consortium.
  • Action: we will set up a meeting with the Japanese team after the meeting.


  • JBR mentioned that it is an R Consortium goal for 2024 to make the opportunity for as many speaking engagements as possible.
  • Ben mentioned that PharmaSUG 2024 is coming up in May,
  • Action: Ben volunteered to submit an abstract by the January 15 deadline. Ning will provide Ben with some copy used for a previous abstract.

The next meeting of the working group will be at 9AM PST on Friday, February 2, 2024.