What do the words turbulent, unprecedented, chaos, tragic and lockdown, to name but a few, all have in common? Correct, the year 2020, and what an unforgettable year that we’ll all remember (but will want to forget) for the rest of our days.
With the chaos, came the challenges and as always, PHUSE rose to them. Working Groups are used to working ‘virtually’ but it was still difficult being unable to get together face-to- face at the annual Computational Science Symposium in Silver Spring. Not only that, we continued to evolve our structure and approach and new and exciting Working Groups were formed. PHUSE Connects also went virtual, and with that came the new PHUSE Technology stack.
Over the past 12 months, PHUSE has invested heavily in enhancing our software tools to support its members in this new ‘norm’. Working Groups migrated from Teamwork to MS Teams and from Wiki to PHUSE Advance Hub. We went from GoToWebinar to ON24 and Zoom. A new website was launched, together with the PHUSE Open Data Repository (PODR) and, PHUSE Education was born.
Stephen Bamford, PHUSE Founder and Chairman of the Board, recently presented a ‘State of the Union’ update, where he shared what’s in store for the PHUSE community moving into 2021. To listen to that recording, click this link.
This year, as with each, the Working Groups Projects continued to meet and collaborate, to bring their deliverables to fruition and, we’ve had a staggering number of beneficial papers published as you can see from the chart below. To read and share any of these papers, click here.
Over the course of the year, we have published 28 deliverables and concluded 12 projects.
Since September, nine new projects have been approved by the Steering Committee Industry Representatives, with a further three due for review in January. So as one door closes, another opportunity opens.
As well as the Working Groups deliverables, we published several blogs including the winners write up for the Computational Science Symposium event. This and many other blogs, can be found here.
The great thing about being part of the PHUSE community is you, and the publication of these deliverables would not have been possible if it wasn’t for the dedication of leaders and members alike, for whom we are ever so thankful. Thank you for all that you do.
Here we provide a summary of activities for each of our Working Groups.
Data Transparency
During 2020, Data Transparency produced nine deliverables. From Best Practice Guides, to COVID-19 blogs, all of which can be found on the new PHUSE website. As well as the deliverables, a new project was introduced, Terminology Harmonisation in Data Sharing and Disclosure. This project aims to collect, align and standardise terminology and their definitions used in future deliverables.
In June, the Working Group held their first multi-day virtual meeting. The sessions featured presentations from Nancy Sager (FDA), André Molgat (Health Canada) and Anne-Sophie Henry-Eude (EMA), followed by a Q&A session. The final 2 days included a tutorial for the use of Synthetic Data and updates on the latest developments within the projects. Click here to view and listen to all recordings.
Following on from the great success of the Data Transparency 2020 Summer Meeting, a Winter Meeting will be held in January 2021. This will run from Tuesday 19th – Thursday 21st (3pm GMT; 10am EST), for 2.5 hours per day. Click here for the agenda and to secure your free place.
Data Visualisation & Open Source Technology
This Working Group which was formed late this year, re-housed some existing projects from the Standard Analyses & Code Sharing Working Group. Led by Hanming Tu and Mike Stackhouse, this group aims to support, address, and answer pertinent questions around Data Visualisation and Open Source Technology.
Since inception, three new projects have been approved, Open Source Technologies for Regulatory Submissions, R Package Validation Framework and Clinical Statistical Reporting in a Multilingual World. All three projects hold regular meetings and are working towards their objectives. To get involved email workinggroups@phuse.global.
Emerging Trends & Technologies
This Working Group has had a successful year and has published four deliverables with many projects concluding.
The Real World Evidence team created a paper on Basic Considerations for the Use of Real World Evidence in Support of Regulated Clinical Trial Submissions, which can be found here. This project is currently reviewing content and ideas captured at the CSS breakout and will look to generate a new project around some of these suggestions, starting in Q12021.
The Cloud Adoption project will be publishing an updated version of their Framework deliverable during the early part of Q12021, and following the publication, they will take on more of a maintenance role, reviewing the paper and updating where necessary.
The Investigating the Use of FHIR in Clinical Research team are looking at how they can evolve as a project. They are currently reviewing materials captured to date and discussing what the next steps are. Once this has been agreed, we’ll be looking to call for a Co-lead to support Geoff Low in this role.
During CSS and in the ‘What’s next for Emerging Trends’ session, many topics were discussed, and the Working Group Leads are currently addressing these suggestions to see what direction is next on the horizon. We’ll share the outcome of these discussions early next year and will look to form new projects and call for volunteers.
Nonclinical Topics
As always, the Nonclinical Topics Working Group held successful breakout sessions during the first virtual PHUSE/FDA CSS. The SEND Data Factory and the SEND Industry Survey team both presented posters at the event.
The Harmonisation of SEND Implementation to Enable Historical Control Data Analysis project formed this year. The team aim to evaluate and recommend approaches for SEND harmonization to better enable analysis of historical control data. SEND harmonization strategies include creation of new variables, controlled terminology, preferred terms, reference lists and/or analysis strategies (scripts) to enable cross study analysis. The team are currently developing strategies to provide supporting information to CDISC for consideration in SENDIG 3.2.
The Nonclinical Working Group have and continue to collaborate with the CDISC Japan User Group (CJUG). The SEND Dataset QC Best Practices team, who are looking to improve the quality of SEND dataset across different stakeholders, are collating a list of questions for the FDA around QCing. The team are including CJUG members as part of the summarisation efforts. Also working with CJUG is the Nonclinical SDRG project. The team requested feedback on the work in progress with regard to the nSDRG template. CJUG provided their feedback and will be reviewing the final version of the nSDRG before publication in early 2021.
Optimizing the Use of Data Standards
During this quarter, six deliverables would have been published, with five projects concluding. At the November Webinar Wednesday, three projects presented their deliverables, and the recording of this event can be found here. They include, Data Standards for Non-interventional Studies, Industry Experiences Submitting Standardised Study Data to Regulatory Authorities and the CDISC Primer.
Some projects within ODS had sub-teams. The SDTM FAQ published a paper on ISS/ISE Strategies and the Industry Experiences sub-team are due to release their final paper over the course of the next week, on the Differences between PMDA & FDA.
Earlier in the year, when the Working Groups were going through a restructure, the project Best Practices for Data Collection instructions published a paper on Adverse Events and Treatment Emergent. Following the publication of that paper under ODS, the projects next steps were to split and look at Adverse Event Collection and Treatment Emergent Definitions as separate projects and were then aligned with the Safety Analytics Working Group.
The Clinical Integrated Study Data & Analysis Data Reviewer’s Guide project continue to progress on the Template Documentation Package with these being ready for public review in February 2021. They have established that there are enough differences between SDTM and ADaM to warrant the creation of two templates, icSDRG and iADRG.
A new project is looking to form by year end on Best Practices for Data Standards Implementation Governance. Data Standards are currently defined by SDOs (e.g.CDISC), implemented and extended at sponsor companies. Decisions made by implementers and data standards organisations are inconsistent across companies but can also be inconsistent within companies. The data standards developed by SDOs cannot be expected to cover all scenarios as prioritisation is required to focus on the areas of the largest impact and will naturally follow new scientific areas or research. We shall be recruiting volunteers in the new year.
Safety Analytics
This Working Group evolved from the Standard Analyses and Code Sharing Working Group back in June this year, and is led by Mary Nilsson, and one of our newest Working Group Leads, Greg Ball.
Sub-teams that fell under one of the original Working Group projects, Analysis and Displays White Papers, became full project teams under the remit of Safety Analytics. Five projects have recently been approved and kick off meetings for each of these have just taken place. They all have a target to produce a deliverable within the next 12 months.
Mary, in addition to leading the Working Group, created an on-demand video and a presentation to support, on Planning and Interpreting Safety Analyses for Integrated Summaries.
To find out more about each project, click here, and if you do wish to join any of the teams, email: workinggroups@phuse.global
As the year comes to a close, we hope the light at the end of the tunnel is in sight. The dedication of all those that have worked tirelessly to find vaccines, will help towards bringing life back to some sort of normality. We hope that you all continue to stay safe, and most of all, are able to enjoy a wonderful festive break with your loved ones.
Happy Holidays!
Chris, Wendy & Lauren