PhUSE Emerging Trends and Technologies Group

PhUSE Emerging Trends and Technologies Group

Geoff Low Dave Handelsman

PhUSE CSS 2015 - ET •  Existing projects –  Lowering Barriers to Cloud Adoption met

•  Five new topics were presented •  Most popular topics: – Statistical Computing Environments (SCE) –  Data Visualisations – Text Analytics in Clinical Research

•  Statistical Computing Environments Project approved!

Lowering the Barrier to Cloud Adoption

Activities •  The core team of the Team used the f2f time to

completely and effectively resolve outstanding loose ends with Edition 2 of the Cloud Adoption Framework. Specifically:

•  Clarification of Cloud-related roles and responsibilities

•  Formulation of a Project closure plan •  Formulation of an outline mechanism for

sustaining the Cloud Adoption framework on an ongoing basis

•  New socialisation model

2015 Deliverables •  Finalisation of Edition 2 of the Cloud Adoption Framework

–  Formulation and insertion of Executive Summary –  Adjustment to framework to embrace ISO-based standards for cloud-

roles –  General tidy-up

•  Publish to PhUSE Wiki and AWS S3 repo •  Set ongoing framework-sustaining model •  Socialisation

–  Loop back with all past team participants –  Loop back with contacts at FDA and EMA –  Discuss further a prep a case-study paper/presentation for PhUSE

Vienna annual conference –  Hold PhUSE webinar (q.v. Scott) –  Leverage framework into FDA training curriculum

Statistical Computing Environments (SCE)

SCE Project Overview During the CSS round table, we had a robust discussion with 19 people from 13 different organizations, developed a large base of material to begin the project and agreed to the following objectives •  Discuss the current state of SCEs, identify common

gaps and share best practices •  Define ideal case user requirements for a SCE •  Clarify expectations for a SCE within industry and

regulatory agencies regarding implementation and compliance

•  Explore SCE relationship to the Metadata Repository (MDR) and the Clinical Data Repository (CDR)

SCE Goals •  Phase 1: Produce a white paper titled ‘State of

the SCE’, describing the current state of SCEs, identifying common gaps and recommendations for addressing

•  Phase 2: Produce a white paper to establish user requirements for an optimal SCE

•  Phase 3: Develop recommendations for how the SCE can best be integrated with the MDR and CDR to have as much of the analysis as possible driven by metadata and automation

SCE Progress Report •  TeamworkPM site has been setup, CSS round table

notes have been added, project plan has been created, first SCE demo video has been created.

•  Recruited 5 new members from targeted organizations and have reached out to 13 others.

•  Project kickoff email sent to team - 3Apr2015 •  Core Team Meeting - 7Apr2015 •  No further CSS support needed at this time.

SCE Milestones •  3Apr2015 SCE – Project kickoff email sent to team •  7Apr2015 SCE – Core Team Meeting •  29Apr2015 SCE - Meeting 2 •  1May2015 - Start White Paper •  20May2015 - Hold SCE round table at PharmaSUG •  21Jun2015 – Lifecyle of a SCE video demos released •  8Jul2015 - SCE - Meeting 3 (tbc) •  14Oct2015 - Hold SCE round table at PhUSE

Conference •  7Dec2015 - Publish White Paper Draft for collegial

review

Data Visualizations

Debrief and Activities •  Time at the CSS break-out sessions was spent

determining what a useful project might look like and what types of data visualizations work, don’t work, and are needed.

•  More volunteers are always welcome! •  A white paper discussing specific use cases and

how data visualization can A) be done well, B) not be done at all and C) be done with extensive work will be developed before the next CSS.

•  Proposal going to Steering Committee this week

Text Analytics for Clinical Research

Debrief and Activities •  Time at the CSS was spent discussing a useful deliverable for text

analytics. •  Though there were many insightful ideas, a clear leader and/or PM

were not identified and FDA does not have the resources to provide these for this project at this time.

•  If there is someone out there who is interested in taking on leadership and management of this team, we can share our notes from the session and help guide them in choosing a focus for a project. –  There were a few volunteers willing to participate that were

identified during the CSS, and we can share their names with interested parties.

Other topics

Projects

•  If you are interested in leading or participating in an ETT Group contact [email protected]

What  is  the  value  of  Big  Data  in  Clinical  

Research?  

Framework  for  mHealth