26Nov2012

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When: 3:00 PM , 26Nov2012
Place: T-con
Facilitator: Lauren Mihalcik
Scribe: Lauren Mihalcik
Attendance: Lauren Mihalcik, Megan Bausman, Judy Henck, Joyce Zandee, Jen Feldmann, Paul Brown, Nancy Everds
Agenda:

  1. Update on outreach to professional societies: SOT, ACT, STP, TS
  2. Update on assistance from Instem marketing group
  3. Discuss concentrating on high-priority questions to prevent early survey burnout
  4. Related: Which questions are high-priority? Data types--to include or not?

General discussion

It was mentioned early in the discussion that the Society of Safety Pharmacology has a working group that is looking into reducing the use of concurrent controls by using historical control data.

Lauren reported on discussions with another WG6 co-chair (Bob Dorsam). Their major deliverable (a survey to rank the importance of standardizing different nonclinical data types, the "Roadmap") will be going out soon (if not already). The survey will be sent around through personal networks and WG6 (via Tim Kropp). (The incoming head of ACT has agreed to send out PhUSE-related surveys as well). To deal with the issue of "official" versus "personal" responses, that survey will include a question that lets people self-identify as providing a company or personal response. There was discussion on the call about whether it would make sense to piggyback directly on the Roadmap survey (either by including a link or being part of the same survey). It isn't clear when/if the survey has already gone out. Lauren will follow up with Bob.

Discussions with Lorrene Buckly (an ACT councilor) concerned ACT's experience getting responses from individuals vs. an official company response. ACT goes to a PharMA rep for each company, asking them to send out the survey to the appropriate person in their organization. It was agreed there were pros and cons to using this approach, especially as the only mechanism of distribution, since there is a risk of very low responses. It may be valid to have both official and individual responses, which would likely be analyzed separately. Several people noted that especially in large organizations, there could be very different responses in different branches/levels.

Outreach to CROs is also important. Paul mentioned the organization IQ PSLG, which he is meeting with next week. He will bring up the survey issue if it is possible (as it is not on the agenda). Working through IQ PSLG may be a way to get a coordinated response from pharmceutical companies.

Jen discussed her conversations with their marketing/survey experts. Instem has offered to host and distribute the survey. They have software that will make analysis (including response analysis) easier. They can do this as a coutesy to PhUSE and will give input on the phrasing of questions to give us the kinds of responses we'd like. They have a database of ~6000 contacts. Jen is pretty certain they can mask Instem's involvement. It seems that with PhUSE as the intermediary, there should not be a problem with FDA involvement, although FDA personel may not be able to access the software (not all survey platforms are allowed from FDA networks). Jen offered to invite a representative from that group to the next teleconference to answer questions.

Lauren noted that the incomplete draft survey was already feeling a bit unweildy and may discourage completion. It was agreed that we should give priority to questions that address the final deliverable for the group, which is a ranked list of priority HD data projects. We can stream line the "current use" section. It was suggested that making parallels between the "current" and "future" section would make it easier to complete. Minimizing typing (as opposed to clicking) would also make it easier. For the ideas for future projects section, we can come up with a potential list and include a spot for other that is free-text.

Another question not currently listed was "What are limitations in using HC data?" (or something similar). A question like this would also give ideas for future projects. This again could have both a checklist response and free-text.

Follow up

  • Lauren will ask Bob Dorsam about the timing of the Roadmap survey
  • Paul will ask IQ PSLG about contributing responses to the HC survey
  • Jen will bring their survey folks to the next t-con and draft a straw man for the poll.



Last revision by Brownp,11/26/2012