September 2019 Working Groups Quarterly

Welcome back! We hope you had an enjoyable summer. We are fast approaching autumn and the PHUSE Working Groups have already published 12 deliverables this year; and with the EU Connect around the corner, many have submitted abstracts for presentations and papers in Amsterdam. You can find all our published deliverables here and the latest information on our upcoming event on our website.

With over 200 new members joining our projects since the beginning of 2019, our Working Groups are continuing to grow. It is an exciting time to be involved in one of our 50+ projects, so why not find out how you can contribute, too. In our latest blog, we will provide further details on each Working Group’s activities and achievements. If you see anything of interest, reach out to workinggroups@phuse.eu to offer your skills and expertise.

 

Announcements:

Over the last quarter we have appointed a new Collaborations Director, a Working Group Lead and two new Industry at Large Steering Committee members.

As Lisa Brooks took up the reins as our new PHUSE Collaborations Director, Janet Low was appointed as Working Group Lead for Optimizing the Use of Data Standards, a role which Lisa was highly active and effective in. We congratulate Lisa and wish her every success as the newest member of the PHUSE BoD.

Janet is an experienced PHUSE member and was instrumental in supporting the creation of the Industry Experiences Submitting Standardized Study Data to Regulatory Authorities White Paper, which is imminent for publication. Janet has presented at US Connects and at SDEs. As Working Group Lead, Janet will join the PHUSE Steering Committee.

In addition, Bhavin Busa and Olivier Leconte were appointed as our new Industry at Large Steering Committee members. Both have been extremely active in supporting PHUSE over the years, and their knowledge and experience will be a great asset to the team.  

 

                                   

          Janet Low                                 Bhavin Busa                           Olivier Leconte                    

 

New Initiative: Knowledge Repository

Being a statistical programmer in the pharmaceutical industry is more than just knowing how to write programming code. Besides strong technical skills, such a role requires comprehensive understanding of the clinical development process, underlying regulations, industry standards and medical knowledge. This Knowledge Repository aims to serve as a quick reference guide. This will be achieved by identifying and referring to existing material, which will be organised in a user-friendly structure. The project will look to split into eight different sub-groups: 

  • Drug Development Process
  • Clinical Study Design and Conduct
  • Clinical Study Workflow
  • Clinical Documents
  • Regulatory Environment
  • Programming
  • Data Standards
  • Therapeutic Areas

If you would like to be part of this new PHUSE initiative, contact workinggroups@phuse.eu.

 

Emerging Trends & Technologies:

The PHUSE Key Performance Indicators & Metrics project has established a set of common data reporting metrics which are more detailed than industry-wide metrics, therefore allowing a greater level of granularity in our project reporting, and business process management. These metrics and their definitions are issued annually as a survey to life science industry companies in order to collect their information. Companies which contribute to the survey will receive the summary report ahead of industry wide release on the PHUSE website. The Year 2 survey is now being distributed to collate information from 20+ companies. Should you wish to participate please contact Workinggroups@phuse.eu.

The Blockchain Technology project recently presented a demo app at the annual DIA Global Meeting. The app looks to provide a welcoming, neutral platform for creating and sharing ideas, implementing data standards processes and tools, and explores innovative methodologies, techniques and technologies. The team are looking to finalise the workable demo app and document this phase of their project.

The Open Source Technologies project’s mission is to provide guidance on the use of open-source technologies in regulatory environments within the pharmaceutical industry. The team recently gave a presentation during our September Webinar. You can find the slides on our webinar page.

The new Real World Evidence project looks to explore the avenues and challenges of using RWE to support regulatory submissions. The first deliverable will be a white paper to document these challenges and propose possible solutions. If you wish to join this project, please email workinggroups@phuse.eu.

The Data Visualisation Best Practices for Interactive Analyses for Decision Making & Submissions sub-team recently completed a submission to the FDA. This included an animation of data in MP4 format, to verify that reviewers would be able to access this also. The team utilised the sample submission process to test the system with this new technology and are now summarising their efforts to help future submissions.

 

Standard Analyses & Code Sharing:

The Analysis and Displays White Papers project team are currently drafting a paper on Output Tips and Considerations. This White Paper will provide general advice on the display of data in tabular form. The intent is educational rather than prescriptive, acting as an aid to consider how to present data in tables. Tables allow for the organisation of alpha-numeric data for easy reference and comparison. The team are hoping to publish this by end of Q4. For further details on the additional White Papers this project will focus on, click on the link above.

Mary Nilsson, Working Group Lead, presented on behalf of PHUSE at the recent DIA Global Annual Meeting in San Diego. This was a great opportunity to promote the progress of the projects. You can read Mary’s presentation here.

During our October Webinar, Hanming Tu, on behalf of the Code Sharing (Repository) project, will be presenting their latest deliverable on TS Domain. This is an R Shiny app for generating Simplified TS datasets following FDA recommendations. Look out for our mailshot to register.

The Communications, Promotion and Education project continues to build upon its education platform Squarespace. The team are looking to create a front end for the Script Repository, with their first priority being safety analytics. A Safety Analytics workshop was run during the summer’s CSS event. Here is a reminder of where to find the recordings and presentation.

 

Data Transparency:

The FDA sent a set of specific questions to seek feedback on the Clinical Data Summary Report Pilot Program and on a new integrated review template for the documentation of new drug marketing applications developed as part of the New Drugs Regulatory Program. A cross-industry sub-team from the Data Transparency Working Group came together to provide their feedback. Some of their comments have been highlighted in a Pink Sheet article. You can also find the full set of comments from 21 organisations/individuals on the FDA website.

The Clinical Trials Data Transparency Toolkit project is soliciting feedback on the Best Practices Guide, which aims to describe the five key elements of clinical disclosure and transparency. Visit the PHUSE website to download the guide and submit your feedback by 14th October.

Jean-Marc Ferran (Qualiance) and Anne-Sophie Henry-Eude (EMA) are holding a Discussion Club at the forthcoming EU Connect. This session will feature a presentation on current efforts from regulators and other organisations to enable data sharing, and a presentation from the EMA on the status of Policy 0070, followed by a Q&A and panel discussion. Click here for more information on how to attend this session.

 

Optimizing the Use of Data Standards:

The ADRG provides regulatory agency reviewers with an orientation to the submitted analysis data in a consistent way and usable format. The package includes information on the Legacy Data Conversion Plan and Report (LDCP) appendix, as well as the template, completion guidelines, and examples. Here is the link to the latest publications.

A new project on the Integrated SDTM and ADaM Reviewer’s Guide has recently kicked off, with the scope of creating a template that can be used for multiple studies. If you wish to join this project, please email workinggroups@phuse.eu.

The SDTM/ADaM Implementation FAQ project team has recently published new responses to questions received, on their Wiki page. You can find a wealth of information on the PHUSE Wiki and if you have a question that you would like the team to address, you can submit it here.

            

Nonclinical Topics:

The Data Consistency project has developed a list of potential inconsistencies that might exist between the SEND datasets and the study report. The group categorised these inconsistencies by possible impact and posted recommended plausible ways to either explain or resolve these inconsistencies on the PHUSE Wiki. The project would like to encourage regular use of the current information and additions to the content, as situations arise in various organisations.

The new SEND Dataset QC Best Practices project aims to explore the variety of QC procedures and tools among different stakeholders and to develop recommendations for efficient and effective SEND QC practices. They, too, recently presented at our September Webinar and their slide deck can be accessed here.

 

Educating for the Future:

The projects within this Working Group have submitted numerous papers for our EU and US Connects. The Data Engineering team will present on Data Sources and Data Engineering Techniques while the Data Science project will be sharing a Poster at our EU Connect. 

The Design Thinking team are curating materials, where they will look to host short webinars dedicated to the various topics around Design Thinking. Further details on this will follow shortly.

The Working Groups Education website provides a good overview of how industry faces the challenges we have around these discussion points. Further blogs will be published in the near future.

 

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