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

Data Transparency 

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.

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. 

Educating for the Future

Ian.Fleming@phuse.eu

Crystal.Allard@fda.hhs.gov

 

Design Thinking Resources

Design Thinking is a process that promises to help tackle big ideas in a manageable and structured way. By definition, it is 'a formal method for practical, creative resolution of problems and creation of solutions'. Design thinking methods foster a way of thinking that reframes the problems and solutions we assume we have the answer to. It also puts heavy emphasis on experimentation, iteration, and user feedback to quickly develop solutions that derive maximum benefit for end users and the actual problems they are trying to solve.

Benefits of employing Design Thinking can include: 1) a focus on the User, 2) leveraging collective expertise, 3) employing empathy, 4) creating value by solving real problems.

Design Thinking is universally applicable because the methods are flexible, to many different types of problems encountered in diverse industries. This is relevant to the life sciences realm because the industry and regulatory bodies are fertile ground for identifying solution-based systems and processes that could benefit from thoughtful re-design. Participants in the PhUSE project would be expected to share their experiences with relevant examples.

Because not everyone can attend the D.School at Stanford University, where design thinking is the core of the curriculum, this project would focus on identifying and collating resources in Design Thinking for consumption by the PhUSE community. Because the actual content is not housed by the PhUSE project, this can include, but not limited to: Books, Journal Articles, Podcasts, Webpages, Recordings etc. This will be achieved by curating and organising content into an easy-to-use structure and making it readily available and navigable technology.

Optimizing the Use of Data Standards

Calling for a Co-Lead

Todd.Bazin@biogen.com

 

Best Practices for Data Collection Instructions

CDISC’s CDASH team provides high level completion instructions related to the core data collection modules. The PhUSE Standard Analysis and Code Sharing Working Group has developed recommended displays (ie, tables and figures) and associated code for use for analysis for data common across therapeutic areas. For some data domains (e.g., adverse events, medical history, concomitant medications, study disposition, pregnancy, reasons for permanent discontinuations from study treatment), having more consistent collection instructions at a more detailed level will potentially lead to increased efficiency (site personnel won't have to learn as many collection methods) and fewer queries (less confusion by site personnel), and will enable sponsors to fully leverage the recommendations and code from the PhUSE Standard Analyses and Code Sharing Working Group. Collection and associated instructions may vary depending on whether the study is early vs late stage, as discussed in the February 2016 FDA guidance ('Determining the extent of safety data collection needed in late stage pre-market and post-approval clinical investigations'). However, reducing the extent of variation would be beneficial for medical research.

This project team will network with CDISC and the Standard Analyses and Code Sharing Working Group to ensure alignment.

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.

Find Out More