Emerging Technologies

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Research, development, and adoption of innovative, but not widely adopted, tools and technologies for leveraging and enhancing the value of healthcare and clinical data. This can include use of existing or immature technologies in innovative ways.

Working Group Overview

New challenges in regulatory science and drug, biologic, and device development provide new opportunities for recognizing and leveraging new or emerging technologies and computational tools or underutilized existing technologies. Initiated at the 2013 PhUSE Annual CSS, the Emerging Technologies working group provides a forum for determining interest in specific computational science topics, tools, technologies, and approaches.

This Emerging Technologies working group will be an open, transparent forum for sharing pre-competitive means of applying new technologies and is being challenged with creation of well-defined collaborative projects that will describe, prioritize, assess, and assist advancement of these opportunities. Possible topics include (but are not limited to) semantic web applications, analysis metadata, modeling, simulation, and “The Cloud”. Projects incorporating these topics might include prioritization, development, and piloting for feasibility and value.

Leadership Team

Vacancy for Co-Leads

We are looking for new leads to take on the Emerging Trends Working Groups.

As a Co-Lead you will:

  • Attend the bi-weekly CSS Steering Committee (SC)
  • Management of the working groups (WG)
    • Lead bi-weekly meetings with the leads of the respective groups under the ET&T purview - track status (participation, velocity and chance of delivery)
    • Coordinate with WG and Wendy/Lauren to ensure that they have all they need
    • Review New Project Requests prior to submission for wider review by SC
    • Provide updates on WG 'Health' as as when needed to the SC
    • Maintain ET&T Project Wikis
  • Help organise and attend the CSS meeting in Washington DC (March).
    • Working with WG to identify candidates for running at the session
    • Managing Logistics with PhUSE Management and WG (incl. content for Brochures, estimates of number of attendees, identification of required resources, etc)
    • Speaking at the Opening Session about the ET&T working groups,
    • Coordinating breakout sessions,

Working with WG leads and PhUSE staff to ensure event runs smoothly Speak at closing session to summarise what was done and what was planned for the next 12 months

  • Attend the Annual Conference (as required) for assisting in running CSS Breakouts
    • Identification of WG able to attend
    • Logistical support (both in advance and on the day)

A couple of other guidelines: Obviously, you must have a passion for the industry. You must also be able to see we have much to do, as there are many places where we can improve - through improved use of technology or adoption of new process. You must be able to speak with confidence and vim to bring people along with you.

Find people with ideas, work with them to put together NPR and assist them in getting the project up and running. Also, be prepared to bug them and make sure that they produce results; either through white papers, presentations at conferences or something else - the success of the projects reflects the success of the collaboration

Note: PhUSE has a strict vendor independence policy which you are expected to uphold at all times. Your role is enablement, and not direction.

Current Leadership Team

Name Role Organization E-mail
Geoff Low ET Co-Lead Medidata Solutions geoff.low (at) phuse.eu
Ian Fleming ET Co-Lead Medidata Solutions Ian.Fleming (at) phuse.eu
Lilliam Rosario Steering Committee Liaison FDA Lilliam.Rosario (at) fda.hhs.gov
Crystal Allard Group Coordinator FDA Crystal.Allard (at) fda.hhs.gov
Steve Wilson FDA Co-Lead FDA Stephen.Wilson (at) fda.hhs.gov

PhUSE CSS 2017

The following projects are meeting at 2017 CSS

The Agenda is as follows:

Current Projects

Cloud Adoption in the Life Sciences Industry

Data Visualisations for Clinical Data

Investigating the use of FHIR in Clinical Research

Clinical Trials Data as RDF

Introduction to Clinical Development Design (CDD) Framework

BlockChain Technology

ODM4 Submissions

Future Forum Interoperability & Technology

Key Performance Indicators & Metrics

Past Projects

Metadata Management

Statistical Computing Environments

Proposed Projects

After the Emerging Technology Round Table Sessions the following projects were identified as prospective working groups for the 2015 CSS and beyond. Some of these need passionate people to lead!

Framework for mHealth

As personal fitness trackers become more ubiquitous, industry is starting to assess how these devices can be used to supplement the clinical record. Very much in its infancy, use of these personal devices is a grey area in terms of adoption status, information quality (for example, the use of proprietary data gathering algorithms), patient privacy and informed consent. This group will develop a framework so companies looking to adopt these devices in their clinical trials can make an informed decision as they assess the potential of integrating mobile health with clinical research.

  • Sponsor: Tony Hewer
  • Needs a Lead?: Maybe

Machine Learning for Clinical Research

With the continually raising profile of Data Science in the Pharmaceutical Industry, techniques which have traditionally not been widely adopted in the industry are starting to become part of a clinical analyst's toolbox. Text Analytics, already employed in other industries, enables analysts to uncover clinically important information in previously opaque free-text. Techniques to be discussed include sentiment analysis, concept/entity extraction, clustering and other approaches. This group will gather people interested in text mining techniques to develop frameworks and approaches for extracting structured information from unstructured clinical trial text data.

  • Sponsor: CDER
  • Needs a Lead?: Yes

Big Data approaches in Clinical Research

Big Data is a term we are all familiar with - it is promoted as the way to comprehensively answer multiple questions across multiple domains. But what is Big Data? Is it relevant to clinical researcher? Is it simply large volumes of data? Is it these large datasets plus the techniques needed to extract value from this data? What approaches work and when? This group will begin by answering the most basic questions associated with Big Data and clinical research -- is it relevant, and where do we go from here? This topic has been previously posed and we have a Project Request: File:ET-project-Template-BigData.doc

  • Sponsor:
  • Needs a Lead?: Yes

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