29 April 2016 Meeting Minutes

From PHUSE Wiki
Jump to: navigation, search

A teleconference and webex was held on 29 April 2016. The working group welcomed B Hayes from the US FDA as a new member. A Brown proposed a strategy for preparing the first draft of a manuscript presenting the materials presented in the 2016 poster at the FDA PhUSE CSS, based on the working group's efforts in 2015. The manuscript could be in the form of a brief paper/communication with the targeted journal: Therapeutic Innovation and Regulatory Science. This journal has previously published papers from the FDA PhUSE Nonclinical Working Groups, most recently the paper: Community opinions on the collection and use of historical control data in nonclinical toxicity studies; 2016: 50(2)174-187. Alan volunteered to prepare the abstract and introduction, based on materials from the poster and wiki page, K Wuersch will prepare methods for the survey taken at the Europ Soc Tox Path, B Knight will prepare a draft of the results, S Toth will work on the discussion, and J Zandee the conclusions/future directions. At least 2-3 sample graphical displays will be included in the paper. The individual sections of the paper should be forwarded to P Drew and A Brown by 27 May 2016 for initial compilation. The working group also discussed next steps for the project which could include a survey with pre-selected answers to derive quantitative data versus more open-ended responses (as in the previous survey). The survey could focus on cross-study and cross-domain analyses (eg, same compound, different compounds, historical controls) to identify what organizations are doing, would like to be able to display and what regulators view as of value. Greater input from FDA is desired. We think that the preparation of the manuscript will lead into questions for the survey.