NEW Safety Analytics

A collaboration working to improve the content and implementation of clinical trial safety analyses for medical research, leading to better data interpretations and increased efficiency in the clinical drug development and review processes.

It is currently envisaged that the educational development elements of this project will form part of the new semi-autonomous Working Group to continue development of educational material for safety analytics.

The major focus for this new Working Group will be ensuring the virtualisation of the CSS event is a success. It will discuss current white papers, forming new projects and running a workshop on safety analytics.Welcome to the Working Groups Summer Blog. We’ve plenty of new and exciting updates to share, so enjoy the read.

CSS here we come! With the event moving to September and becoming virtual, the PHUSE Working Groups and their project members are currently working on planning their virtual breakout sessions. We are pleased to announce three FDA presentations within the Plenary Session and two Panel Discussions around the first PHUSE/FDA Innovation Challenge, and COVID-19 Lessons from Agility in a Pandemic. We encourage you to sign up to hear progress made, next steps, innovative ideas, workshops, hackathons and more. Early Bird has now closed, but you can still register at a reduced rate.

Following the BoD discussion in January, the PHUSE Working Groups have started their evolution. A number of projects have closed, with additional projects to close over the next few months, as they complete their deliverables. We are pleased to announce two NEW initiatives to help support the PHUSE Working Groups and their members, together with the launch of two NEW Working Groups. You’ll hear more in the coming weeks about PHUSE Technical as one of the new PHUSE initiatives.

NEW PHUSE Education

As a global community of clinical data scientists, we have a diverse membership mainly covering the pharma and healthcare industry, CROs and software vendors at all levels of seniority. We are more than ever competing with other industries, especially in recruiting and retaining fresh data scientists. Education has become a major challenge, with our rapidly changing environment, in regards to technology and methodology. PHUSE Education will look to create a roadmap to education, which will cover the broad bandwidth of knowledge a clinical data scientist needs to have to be successful in their job.

The team will address hard business skills such as programming languages and statistical methodology, soft business skills such as project management and presentation techniques, technology skills such as various tools for database design and statistical analysis and domain understanding skills such as the regulatory landscape and the overall drug development process. Click to read the full Education Strategy, where Sascha Ahrweiler shares further detail about how PHUSE’s Education framework has been designed to close the relevant gaps in what we do.

As such, the Educating for the Future Working Group will now form part of this new structure. The team is currently working on training materials and building the knowledge base and will look to launch in Q3, so watch this very exciting space.

Two NEW Working Groups:

The Standard Analyses & Code Sharing Working Group as we currently know it will be realigning to meet industry needs, splitting into two new and exciting Working Groups: Safety Analytics led by Mary Nilsson, and Data Visualisation & Open Source Technology in Clinical Research, by Hanming Tu and Michael Stackhouse.

NEW Data Visualisation and Open Source TechnologyThis Working Group will aim to support, address and answer pertinent questions around data visualisation and open-source technology. The combination of these two subjects is natural in today’s environment given the powerful data visualisation tools within the open-source languages available today.

Two new projects have formed within this Working Group:

• The R Package Validation Framework team is looking to develop a white paper which will serve as a reference for industry on how to perform validation for user-contributed extensions of programming software, and an R package. The R package will be developed to provide the tools and guidance for validating an R package.
• Open Source Technologies for Regulatory Submissions will explore the technologies used in regulatory submissions.

In collaboration with the ASA, PHUSE has formed a new project which looks to develop R-Shiny applications to generate identified plots for direct inclusion in submission packages for regulatory agencies. The R-Shiny Interactive Forest Plot project is currently investigating tool specifications to generate forest plots.NEW Safety AnalyticsA collaboration working to improve the content and implementation of clinical trial safety analyses for medical research, leading to better data interpretations and increased efficiency in the clinical drug development and review processes.

It is currently envisaged that the educational development elements of this project will form part of the new semi-autonomous Working Group to continue development of educational material for safety analytics.

The major focus for this new Working Group will be ensuring the virtualisation of the CSS event is a success. It will discuss current white papers, forming new projects and running a workshop on safety analytics.

Emerging Trends & Technologies

The Emerging Trends & Technologies Working Group continues to research, develop and adopt new innovative technologies. However, there are some changes being implemented to refocus the scope of the Working Group. The Data Visualisation and the Best Practices for Interactive Analyses for Decision Making & Submissions project have migrated across to the new Data Visualisation and Open Source Technology in Clinical Research Working Group following the restructure. Be sure to join the ET&T Breakout Session during the CSS to see what’s next for this Working Group.**Deliverables published **The following projects have closed out the first half of the year producing valuable deliverables.

• Use of Data Visualisation for Subject Level Data Review
• The KPI Year 2 report will be shared in September and published on the PHUSE website.
• Real World Evidence

Data Transparency

The PHUSE Data Transparency Summer 2020 Multi-Day Meeting (3rd–5th June 2020) was a huge success, gaining a 98% satisfaction rate from our attendees. The event brought together engaged individuals on a global scale, and we thank all involved for contributing to what was a brilliant event. Want to catch up? Visit the engagement hub to watch all live recordings.

Data Transparency has a new project: Terminology Harmonisation in Data Sharing and Disclosure Deliverables. Led by Lukasz Kniola and Sarah Hewitt, the team hopes to collect, align and standardise terminology and their definitions within data sharing and disclosure to be used in future PHUSE deliverables.Deliverables publishedIn addition to the Summer Meeting held in June, the Data Transparency Working Group has published eight new deliverables, which is a staggering achievement. Click below to read the papers and references.

• GDPR White Paper
• Clinical Trials Transparency and Disclosure: A Global View White Paper
• A Global View of the Clinical Transparency Landscape—Best Practices Guide
• Data Transparency – FDA Pilot Review Comments (reference)
• PHUSE Data Transparency Group’s Response to NOT-LM-20-003: Request for Information (RFI): ClinicalTrials.gov Modernization
• PHUSE re-start of EMA Policy 0070 suggestions (reference)
• The Impacts of COVID-19 on Clinical Trial Transparency and Document Disclosure Blog
• Data Anonymization & Risk Assessment Automation

Optimizing the Use of Data Standards

• The Clinical Integrated Study Data and Analyses Data Reviewer’s Guide will create two templates: icSDRG and iADRG. This project provides a collaborative, non-competitive forum for industry to share submission experiences including, but not limited to, submission planning, interactions with the regulators, test submissions and regulator feedback. Additionally, this project will explore the development of best practices for biometrics departments to engage with regulators. It will examine different communication use cases and make recommendations for ensuring effective exchange of information. The project plans to publish these templates by year end.
• The SDTM/ADaM FAQ and CDISC Implementation projects recently presented a project overview and their findings to date at the CDISC Webinar. The recording and slide decks can be found here.
• The SDTM/ADaM FAQ team has also published team responses to FAQs received over the last quarter. The team’s output can be found here. If you have a question that you would like the team to address, submit it here.

Nonclinical Topics

We are pleased to announce a new collaborative project with BioCelerate: Harmonisation of SEND Implementation to Enable Historical Control Data Analysis. The scope of this project is to evaluate and recommend approaches for SEND harmonisation to better enable analysis of historical control data, developing a solution framework for variability that includes representation of stakeholders involved in the creation and use of SEND datasets. If you are interested in participating, contact workinggroups@phuse.eu.**Deliverables published **- Recommendations for Anti-Drug Antibody Modelling in SENDIG White Paper

Standard Analyses & Code Sharing**Deliverables published **- The Best Practices for Quality Control & Validation project has now closed out after publishing a White Paper to detail the concepts, best practices and methods for quality control and validation of analysis programming used for clinical trials.**Concluded Projects **- The Communications, Promotion & Education project has closed out after successfully developing a Communication Plan that conceptualises efficient ways to communicate Working Groups’ progress and results.

This Working Group has now concluded, as addressed above.Here is what we expect to publish by the end of Q3! Keep a look out on the PHUSE website for updates.

• SDTM FAQ Implementation – ISS/ISE White Paper
• Industry Experiences Submitting Standardized Study Data to Regulatory Authorities
• Differences between the PMDA/FDA
• Output, Tips & Considerations White Paper
• CDISC Implementation Primer
• GPP in Macro Development
• Data Standards for Non-interventional Studies
• Special Topics of Interest White Paper
• Implementation Guide for Clinical Data Scientists – COVID-19 (special project)
• Best Practices for Data Collection Instructions

As you can see, the output from the projects has been remarkable, especially as we all face these uncertain times around the globe. This just shows the dedication of our volunteers, so a HUGE thank you to you all from the PHUSE team. We’re accelerating fast towards the CSS and look forward to collaborating with you albeit virtually.