11Jun2012

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When: 10:00 AM Place: T-con
Facilitator: Lauren Mihalcik
Attendance: Lauren Mihalcik, Joyce Zandee, Judy Henck, Paul Brown, Louis Norton, Ben Sefing


Agenda:

  1. Overview of WG6 and how the HC project originated
  2. Goals of the project (i.e., not creating a magical HC database)
  3. Group leadership and recruitment
  4. How to proceed on task 1 (published definitions vs. working definitions)
  5. Future T-Con scheduling

Overview of WG6 and how the HC project originated

  1. Meeting in March in Silver Spring, MD
  2. Broad stakeholder representation
  3. Pre-meeting survey of needs/challenges concerning nonclinical data
  4. Resulting list prioritized at the meeting and subgroups created project plans
  5. “historical controls” a recurrent favorite

Goals of the project

  1. (i.e., not creating a magical HC database)
  2. Define what we mean when we talk about historical controls
  3. Gather ideas people have about putative projects and benefits around the issue
  4. Critique and prioritize based on consensus criteria (e.g., usefulness, validity, feasibility)

Group leadership and further recruitment

Louis will have to step away as co-chair of the group, and Lauren will be taking an extended leave in early 2013, so we need at least one co-chair or chair to carry the group forward.

  1. AI: Consider being a chair or co-chair and report back on the next t-con
  2. AI: Consider who you know at other organizations that would bring an interesting perspective to the group

How to proceed on task 1: Defining HC data

  1. Discussion: What counts as historical control data?
i. Is it the summary statistics or individual data points?
ii. Data from control animals only or also baseline data points for treated animals?
iii. Should we include positive controls?
iv. It may be wise to not limit the kinds of data until we get to the prioritization phase. Keep everything in the hopper.
  1. Types of HC data
i. Numeric, summarized as e.g. means
ii. Observational (clinical observations, pathology), summarized as frequency.
iii. Other not in those categories?
  1. Published vs. working definitions
i. Let’s avoid reinventing the wheel. What has been published about historical controls and the use thereof?
ii. AI: Search in your area for what has been published on the use of historical controls, including definitions. Post a link or the paper to our wiki after getting an account.
iii. AI: Lauren will make a place for publications on the wiki.

Future T-Con scheduling

  1. Calls every two weeks
  2. AI: When-to-meet inquiry will go out later this week. Assume that this represents the first of every-two-week calls and check your calendars for the future.

All Action Items

  1. AI: Consider being a chair or co-chair and report back on the next t-con
  2. AI: Consider who you know at other organizations that would bring an interesting perspective to the group
  3. AI: Search in your area for what has been published on the use of historical controls, including definitions. Post a link or the paper to our wiki after getting an account.
  4. AI: Lauren will make a place for publications on the wiki.
  5. AI: Respond to when-to-meet inquiry later this week.

Last revision by Lauren.mihalcik,06/11/2012