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

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.

GDPR Impact on Data Collection Practices 

 

 

Sub-team Lead

brusin@mmsholdings.com

Data Breach 

As part of the wider GDPR team this sub-team is looking to focus on data breaches, database access and communication issues and how the sharing of data works between clinical sites and CRO's. 

 

This sub-team will provide examples of breaches and investigate how, why and if the breaches where handled correctly to provide best practices in the form of a white paper.

 

Nonclinical Topics

alan_p.brown@novartis.com

philip.drew@pds-consultants.co.uk

Data Visualisation as an Enabler for Nonclinical Safety Signal Detection 

The overall objective is to explore how data visualization can be used as a means for enabling safety signal detection within the scope of nonclinical data. To augment this, algorithms for assisting in the identification of safety signals will be identified in the literature (and from the public domain) and considered for investigation as case examples using suitable data, such as may be available from research databases.  As an example, analyses of clinical trial safety data have utilized eDISH plots of serum ALT activity and total bilirubin levels for signal identification of hepatotoxicity (based on Hy’s Law). Could this and similar approaches be translated to nonclinical data?

The intent is for the project to utilize existing software visualization tools (including HistoGraphic which was developed in the team’s preceding project) to demonstrate potential safety signal detection using the identified algorithms or visual cues. The project will not expand into the development and/or evaluation of visualization software.

A key project deliverable will be to reinforce the importance of promoting standardized nonclinical safety data in SEND format (e.g. LB, MI & MA domain data) as a signal alert enabler.

The project will use non-confidential, nonclinical data from the IMI eTOX/eTRANSAFE Consortia (in the European Union) for real-world evaluation of cross-domain algorithms which may identify safety signals in nonclinical studies.

Project communication and documentation will be managed via a PhUSE wiki-page, consistent with prior related projects.

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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