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The Working Groups have hosted multiple successful events in the past quarter, which have covered several topics within the industry.  

PHUSE CSS 2024 

Held on 3–5 June in Silver Spring, Maryland, the PHUSE/FDA Computational Science Symposium (CSS) 2024 brought together a community of 212 passionate individuals. 

The event showcased a dynamic agenda packed with 30+ Working Group Breakout Sessions, two Plenary Sessions, two Hands-on Workshops and a Poster Session. Attendees gained access to direct insights into regulatory topics from health authorities and explored a range of ideas crucial to the future of computational science. 

The CSS stands as a testament to the industry’s commitment to advancing drug development and regulatory science through both collective effort and data-driven decision-making. Read more about the PHUSE CSS in our latest blog post. 

There are 3 events coming up within the Working Groups

Data Transparency Autumn Event 

So far this year we have had 12 virtual Working Group events, with more planned in the coming months. Over 1,500 attendees have attended our Working Group events so far this year!

There are four events coming up within the Working Groups over the next few months:

• Open Forum: What is the True Cost of Open Source? 

The Open Source Technology in Clinical Data Analysis (OSTCDA) project was set up with the aim to create a manuscript on the integration of open-source software solutions for clinical data management, analysis and reporting.

Questions we will address during this Webinar:

• What is the true cost of adopting open-source tooling for clinical trial data analysis?
• Can the industry fund open-source?

In addition to the GitHub Discussion, we are hosting a series of forums throughout the year. See the Working Group Events page for further details.

This Forum will be taking place over Zoom on 13 September at 15:00-16:00 (BST) / 10:00-11:00 (EDT).

• Data Transparency Autumn Event

The PHUSE Data Transparency Autumn Event is taking place 17–19 September 2024. Data Transparency Events offer you the chance to gain knowledge and experience from a wide data transparency community, allowing you to come together with experts from a variety of companies and backgrounds. During this virtual event, presentations will be delivered across the three days in bitesize chunks

from 15:00

 to 17:30 (BST)

Community Forum – 11 July 

• The Real World Evidence Working Group is hosting their third Community Forum of the year! This forum will looking at 'Understanding the Complete Journey of RWD, from Data Source to Final Analysis'. 

Open Source Forum – 12 July 

• The Open Source Forums will be continuing into July on the topic of Regulatory Acceptance of Open-Source Submissions. Registration will open soon. 

. There will also be a panel discussion and Q&A session focused on the days’ themes.

• Regulatory Landscape of AI/ML in DHTs (Current Landscape, Knowledge Gaps, Best Practices for Regulatory Submissions, Challenges of Regulating AI)

Digital healthcare technologies (DHTs) show significant potential for enhancing data acquisition in clinical trials by enabling objective and accurate data collection. DHTs include wearable devices – sensors, smartwatches, fitness trackers – that continuously monitor vital signs, physical activity, sleep patterns, and medication adherence. Some DHTs, such as smartwatches, can be used in clinics and at home for remote patient monitoring. Moreover, DHTs facilitate real-time data monitoring and safety analysis, enabling prompt identification of trends, outliers and adverse events. This timely information supports early intervention and decision-making, thereby improving participant safety and overall trial efficiency.

However, the emergence of DHTs also raises regulatory-related questions. In this PHUSE quarterly forum, we will discuss the development of digitally derived measures (clinical outcome assessments and biomarkers) and germane regulatory policies from the perspectives of government and industry experts.

• Open Forum: Open Source Technologies in Clinical Data Analysis 

A significant amount of time and energy has been invested in recent years in exploring the desirability (do we want it?), feasibility (can we do it?) and viability (is it worth it?) of integrating open-source solutions into our clinical data pipelines, which transform source data into clinical study reports and submission data packages. In this October edition of the Open-Source Open Forum, we will update on the status of this initiative and continue to hear from you on what we’ve missed so far.  

When this manuscript is complete, we hope to put to rest some of the burning questions we believe we now know the answers to. This will allow industry, and all the passionate people in it, to look ahead and start tackling the next horizon of challenges related to using open-source solutions for clinical data pipelines. We hope you will contribute your expertise to this effort.

TheUnderstanding the Complete Journey of RWD, From Data Source to Final Analysis project held its 3rd Community Forum in July, with 91 in attendance.In this forum, the speakers shared examples from their experiences of the step-by-step process of real-world evidence (RWE) generation, beginning with identifying appropriate RWD, mapping and cleaning the data to create the necessary analytic files, through to the final analysis resulting in RWE. They also highlighted the challenges they have faced and the solutions they have implemented. Examples covered include therapeutic areas such as adult growth hormone deficiency (AGHD), drug-resistant epilepsy, and Alzheimer’s disease. Through these examples, we hope it provided insights into the complexity of working with RWD and shared successful ways to overcome these challenges.

The Open Source Technology in Clinical Data Analysis (OSTCDA) project held its 4th Open Forum in June. There were 119 people in attendance, and the questions addressed were:

• How do you establish reproducibility and traceability with open-source solutions, e.g. R package management?
• How do you document your trust in an open-source solution to satisfy a third-party enquiry?

TheOpen Source Technology in Clinical Data Analysis (OSTCDA)held its 5th Open Forum, with 137 in attendance. Questions we addressed during this webinar:

• How do you establish reproducibility and traceability with open-source solutions, e.g. R package management?
• How do you document your trust in an open-source solution to satisfy a third-party enquiry?