WG6 Data Interconnectivity meeting minutes: 09 May 2012

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When: 10:00 - 11:00am EST , 09 May, 2012
Place: TC and live meeting
Attendance: Jyotsna, Paul, Jeremy, Suresh, Latha
Agenda: understanding safety pharmacology CV data, and interconnectivity possibilities

Introduction

Overview

Consider the various types of data collected through Cardio Vascular studies in Safety pharmacology. Discuss possibilties and challenges of connecting such data together. Potential to link with clinical data with examples.

General discussion

  1. Start talking about CV endpoints such as ECG data captured during safety pharmacology studies. Can we get example data from some participating companies to look at interconnecting such data between animal and clinical studies.
  2. Plan to use as the example use-case for discussion at the next meeting.
  3. PointCross's NIMS system at FDA is used for data standardization.
  4. Some other group may be doing standardization.
  5. We should figure out the metadata which will be the basis of performing interconnectivity between complex data types using meta-analyses.
  6. Across species verus within species analyses. How can interconnectivity be achieved?
  7. Availability of sample clinical data versus availability of animal data. Examples of data collected from CV studies would be blood pressure (BP), EEG, ECG, EKG, etc.
  8. Sharing and exchanging of data for use in the subgroup. What are the challenges and confidential issues?
  9. Does FDA have legacy data under the FOI (Freedom Of Information Act)? Not sure if we can actually get the data.
  10. Options are to look within our individual operating companies to look for sanitized data that may be available for sharing within the group or publicly. Some contacts provided by PointCross based on past collaborations.
  11. Pharmacological class taxonomy. Look at available information with PointCross versus EPC (Established Pharmacologic Class). Look at link to FDA site [1]
  12. Cheminformatics does this type of data integration, perhaps similar strategies may be used for linking across and within drug classes. Look at examples.

Objectives:

   * Get some sample data or generate data if possible & look to draw conclusions on the data.
   * Make conclusions and then try to validate on real data later. 

Follow up and Action items

  1. Reach out to PhUSE workgroup #3 on Clinical Data Integraton - Jyotsna
  2. Get example interconnectivity data for next discussion meeting in 2 weeks - Suresh, Latha
  3. Pharm classes document EPC - Latha, Jyotsna
  4. Contact people at J&J about data sharing - Jyotsna



Last revision by {{RE VISIONUSER}},10/16/2012