BPDCI 19 Jan 2018 Meeting Minutes

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  • Todd Bazin
  • Mary Nilsson
  • Sharon Weller
  • Cathy Bezek
  • Alec Vardy


1. Welcome: Alec Vardy from Jazz Pharma to the team!

2. PhUSE CSS and CDISC Working Group Meetings

PhUSE CSS: 4-6 March 2018 (Early bird registration ends 26-Jan) CDISC Working Group Meeting: 7-9 March

3. White Paper Status

4. CDASH Extended Team Presentation (11-Dec-2017)

a. Feedback from Team

5. Adverse Events - Determine Best Practice Recommendations Related to the Following:

a. Tracking AE and MH Severity & Seriousness – Tell the complete story of what happened to the patient • Collect new AE record ONLY when severity increases or seriousness changes from non-serious to serious. This concept also applies to ongoing MH events – i.e. only create an AE record if MH event increases in severity or becomes serious? • Collect new AE record when severity increases or decreases; or when seriousness changes from non-serious to serious or serious to non-serious?

Per PhUSE white paper ‘Analysis and Displays Associated with Adverse Events Version 1.0 – 2017-FEB-03’:

“Having a collection method that captures improvements (ie, all changes in severity) does provide better data for individual case reviews (eg, enables the graphical summaries of AEs over time) …”

“Having a collection method that captures changes in severity over time also provides more complete data for potential ad-hoc exploration that may not be possible otherwise (eg, potential relationship between agitation/activation and suicidal thoughts and behaviors).”

b. Intermittent events - (eg, headaches) – These are sometimes captured as one event over a long period, or sometimes each event is captured. These variations make summaries of the number of events difficult to interpret.

c. Serious events occurring after study completion – In some collection methods, serious events occurring after study completion are included in the study clinical trial database, while in other collection methods they are included in alternate data systems.

PhUSE analysis and code sharing team recommends “that the clinical trial database include all serious events that occur during a study and not include serious events that occur after the study is considered complete for the patient. Predefined follow-up phases should be considered part of the study and part of the design of the study.”

Meeting Discussion

1. CDASH Team Recommendation - Rename project 'Best Practices for Data Collection Design and Collection Instructions' or 'Business Rules for Data Collection Concepts'.
(A) Todd to work with Jane L. on naming and circulate to team.

2. White Paper Strategy: Mary N., based on her experience, suggested that a white paper be released for each individual domain. That is, for now, focus on releasing the white paper for disposition (i.e. End of Treatment, End of Study). Team agreed.
(A) Todd to draft white paper for disposition and work with Mary on v0.1 prior to team review.

3. Study Coordinator input: Need site perspective as part of this time. Invaluable input. Much of our focus is centered on defining universal collection best practices which has a significant impact on sites. Need representation from this role.
(A) Alec to reach out to investigational sites on Standford campus for rep.
(A) Todd to reach out within Biogen Clinical Ops for rep.
(A) Sharon to reach out within Lilly for rep/contact.

4. Adverse Event Data Collection
Alec noted that an important topic to address (i.e. question to answer) is how to define severity. Should CTCAE grading be applied across the board for consistency? This provides a framework for scoring events consistently. Loaded question though because it could likely lead to a query nightmare! Alec noted that it's key to focus on AEs of special interest early on and then possibly enforce tighter rules on those AEs? NOTE: Team stated that this is a challenging topic because it's often a situation of using such a scoring for oncology studies but not for others.
(A) Todd to work closely with Mary and her team to define clear list of questions to address. However, it would also be appropriate for this team to focus on tracking 'what happens to the subject'. If we define rigorous collection then will lead to more options from an analysis standpoint.

Action Items

See Action Items bolded above.