Call for Project Volunteers & New Project Suggestions

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.

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 wendy@phuse.eu

Working Group & Project Lead

Project Title

Description

Data Transparency 

jean-marc.ferran@phuse.eu 

 

 

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.

Optimizing the Use of Data Standards

yuliia.bahatska@syneoshealth.com 

vladlen.ivanushkin@gmail.com 

Data Standards for Observational Studies

 

Currently there are no strict standards and guidelines for observational studies. In this project we would like to study the challenges that programmers face during creation of the analysis datasets and handling of the data for observation studies. The plan is to network with the programmers who have experience in observational studies and summarise the most frequent issues they have faced. The next step would be to discuss and optimise the ways they can be resolved from programming and data handling perspectives. Also data transparency should be taken into account in the discussion of dataset creation. If possible CDISC experts should be involved in the project in order to provide guidance. The results are to be presented in the form of a White Paper.

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