NICE Minutes 2013-10-16

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When: 09:00AM , 16Oct2013
Place: Webconference
Facilitator: Paul Cornwell
Scribe: Alan Brown
Attendance: Sue DeHaven, Alan Brown, Paul Brown, Jane Reed, Ron Filler, Paul Cornwell

  1. Follow-up to any action items from last meeting (see wiki notes, items for Paul C)
  2. Identification of use cases for evaluation. The following use cases were identified by the Endpoint Predictivity group : a) HERG/CV safety/QT, b) transaminase changes in rats and man, c) new kidney biomarkers and clinical correlates (available nonclinical and clinical data are likely limited for this use case), d) CNS adverse events/findings. The following use cases were identified by the Data Interconnectivity group and related to endpoint predictivity: a) HERG/CV safety pharmacology/QT, b) cardiac safety/cardiac biomarkers. There are some common themes between the groups.
  3. I propose that we select 2 different use cases and have individuals volunteer for at least one. The use cases should be ones in which we are confident of having nonclinical and clinical data readily available. Each subgroup can identify goals and objectives for their project. A common goal would be to develop models for correlating electronic nonclinical data with clinical data . What data are needed and how should the data be analyzed ? What correlations can be made ? Does the nonclinical data agree/disagree with clinical outcomes ?

General Discussion

Discussed initiation of analysis of a use case correlating clinical adverse events (AEs)/safety concerns with nonclinical data, with a focus on central nervous system (CNS) AEs. Various drugs have been removed from the market ( example is the weight loss drug, rimonabant, which was developed by sanofi-aventis but subsequently removed from the EU market due to neuropsychiatric AEs) or had label changes due to CNS-related AEs. Clinical AE data should be more readily available compared with human laboratory or pathology data. Clinical and nonclinical data related to this topic are available from the FDA website (SBA’s), label changes, Clinical Trials Database, National Toxicology Program, and FDA adverse event reporting (AERS). Potential questions include: How would nonclinical and clinical data be analyzed together regarding CNS actions ? Were clinical signs seen in general toxicology studies predictive of clinical AEs ? Can this analysis be done with SDTM ?

Follow up

Start identifying case example drugs and datasets for evaluation using sources indicated above.

Last revision by Pacorn,11/19/2013