Call for New Projects & Leaders

The PhUSE Collaboration is accepting proposals for new projects. A proposal will address problems of significant relevance to computational science related to drug, biologic and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements: 

  • The projects must address significant research issues relevant to computational science
  • The project must not attempt to address FDA policy issues
  • There must be at one Project Lead personally involved in planning and carrying out the project.

New Projects can be submitted anytime during the year, however, in order to be included in the March meeting, new projects must be submitted by end of the previous year. If chosen, the project team will prepare objectives and an agenda for a project team meeting at the Annual Computational Science Symposium in March of the following year.

Projects of Particular Interest to the the Collaboration include:

  • List and prioritization of issues in drug, biologic and device development related to computational science
  • Identification of possible projects based on pressing issues in drug, biologic and device development related to computational science
  • Identification, prioritization and potential pilots of emerging tools and technologies
  • Projects that fall within the scope of existing defined working groups

Application Process

Complete a New Project Request

Completed forms should be sent as an email attachment to css@phuse.com.

Call for Volunteers - New Projects

Working Group & Project Lead

Project Title

Description

Optimising the use of Data Standards

spauwel2@its.jnj.com

 

GDPR impact on Data Collection Practices

In May 2016, the new EU General Data Protection Regulation (GDPR) was released and will become applicable in all member states two years after publication on May 25th, 2018. The GDPR was designed to harmonise data privacy laws across Europe, to protect and empower all EU citizens' data privacy and to reshape the way organisations across the region approach data privacy.

An important requirement from the GDPR is the minimisation of collection of personal data on basis of necessity. There are also examples of countries (e.g. France) that are putting local legislations in place regarding collection of personal information and specifically Date of Birth (e.g. France: day of birth cannot be collect in any trial with an FPI after August 14th 2017 except for children aged 0-2 years).

The goal of this project is to share experiences and approaches for collecting date of birth and other personal information in compliance with regulations. For example, the project will explore the impact of collecting minimal expected information on Date of Birth; by only collecting Year of Birth (collected) and Age (collected or derived ) for standard clinical trials. The project will create a best practices white paper to summarise experiences and recommendations. 

As the project progresses, it may also explore other general EU regulations and aspects of the GDPR such as the GDPR implies that subjects should be allowed to have their data deleted after it was collected which seems to conflict with GCPs requirement of the need for an audit trail.

Educating for the Future

ian.fleming@phuse.eu

mc_dermotts@me.com 

 

Educating for the Future

Methodologies and technologies utilized in the clinical development process have been largely unchanged since 2005. Externally, there have been immense advancements in technology and mindsets related to working with data that have had little impact in our industry. This Working Group sees this as a risk. The risks breakdown into 3 categories:

1) There is a risk of advancement happening outside of our domain that may expose us to threats that we are unable to protect ourselves against.

2) There is a risk that our skill sets and capabilities become outdated and external forces strongly influence the Industry without us having a say

3) There is a risk that we are missing opportunities to become more efficient and to use these advancements to deliver better value for patients

The goal of this Working Group is to develop frameworks by which to educate the PhUSE community at large. The frameworks will be designed to educate the community on the importance of topics where we feel we have gaps, the details of the topics themselves, and how they can be used to drive innovation in the industry

Emerging Trends & Technologies

shume@cdisc.org

mhungria@dicoregroup.com

nate.c.blevins@gsk.com

ODM4 Submissions

Widespread support exists for modernizing the data transport format for the standardized submissions of clinical research data as part of an application to a regulatory authority. Despite the known limitations of the outdated SAS® Version 5 Transport (SAS V5 XPORT) format, it remains the current standard transport format for regulatory submission datasets. Its limitations are impacting the CDISC standards data representations as well as the technologies available to support data exchange. The Operational Data Model (ODM) standard has been the CDISC standard format for data exchange since 2000. Define-XML and Dataset-XML are ODM extensions supporting the transport of CDISC dataset metadata and data, respectively. Define-XML is now a required part of a regulatory submission. However, despite using Define-XML to submit dataset metadata, other data and metadata required for submissions are submitted in different file formats that adversely restrict data representation, machine-readability options, and the ability to validate submissions. This paper describes how the use of the existing ODM standards could simplify and modernize data exchange in support of regulatory submissions, as well as improving data exchange practices in other areas of clinical research.

Optimising the Use of Data Standards

 

Todd_Case@vrtx.com

 

Industry experiences submitting standardised study data to regulatory authorities

FDA & PMDA require standardised study data for certain regulatory submissions. Industry approaches to meeting these requirements vary across companies. This project provides a collaborative, non-competitive forum for industry to share submission experiences including, but not limited to submission planning, interactions with the regulators, test submissions, regulator feedback, etc. Additionally, this project will explore the development of best practices for biometrics departments to engage with regulators. Historically, biometrics departments have not directly interacted with regulators but relied on internal regulatory affairs departments as an intermediary. The project will examine different communication use cases and make recommendations as to ensure effective exchange of information.

Standard Analyses & Code Sharing

Hanming.Tu@gmail.com

 

Script Metadata for Sharing

Since the PhUSE scripts repository was created in GitHub in 2013, many scripts were contributed and hosted in the repository. The Standard Analyses & Code Sharing working group (SACS) in PhUSE recommended coding style and guideline and developed qualification process to review, develop and share the scripts. Many developers from other working groups started using the repository to share and host their scripts as well. FDA contributed the JumpStart script packages to the repository as well. The script discovery and acquisition team in the working group has gone through two-round reviews of the JumpStart scripts. The working group had recommended folder structure, file naming convention and initial scripts metadata in YML format. Wouldn't it be nice if you could automatically download and execute a script once you know the name of a script and only need to provide a few parameters in  a configuration file (script metadata file?) This project will explore how to use script metadata to increase the accessibility, reusability and automation of scripts in the repository.

Emerging Trends & Technologies 

Geoff.Low@phuse.eu 

Scott.Bahlavooni@phuse.eu 

Chris.Price@phuse.eu 

Working Group 

Co Leads

Geoff Low will be stepping down as the Working Group Lead due to current workload within his day job. Ian Fleming has now taken on the role of Working Group Lead for Educating for the Future and is therefore also stepping away from Emerging Trends and Technologies. 

The expectations for this role include; 

  • Attend and provide project updates at the bi-weekly Steering Committee meetings. 
  • Lead the project leads bi-weekly calls, where projects provide an update on progress.
  • Review and provide input into PhUSE deliverables and new projects put forward. 
  • Provide guidance and support to project related queries 
  • Lead breakout sessions on behalf of Emerging Trends & Technologies during the CSS Annual Conference 

Geoff will support in the handover of this role with a view to finally stepping down following our US CSS event in March. 

Want to Co-Lead a project? Great ideas waiting for Leaders

While working groups and projects continue to collaborate, new innovative ideas are generated by different teams. Unfortunately, the collaboration doesn't currently have individuals able to volunteer in a Co-Lead role to move these ideas forward. Below is a list of potential projects, the associated Working Group and a description of each. If one of these ideas interests you and you are able to volunteer to Lead, please contact wendy@phuse.eu

Project Ideas

Working Group

Description

 

 

 

 

 

 

 

 

 

Do you have feedback to share? Got an idea? Want to comment on a project?

All comments and feedback welcome. Please contact Wendy@phuse.eu

Current CS Working Groups

For information on current CS Working Groups, please visit the PhUSE Wiki page.

Thinking of joining PhUSE?

Already a member but not sure how you can benefit?

PhUSE is an expanding, global society with a membership of more than 8,000 clinical data scientists. It requires a large pool of resources to help with its running so offers many opportunities for members to become involved. Whether it's chairing a conference, presenting at an event, leading a working group or contributing to the quarterly newsletter, we are always keen to hear from volunteers.

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