More than a hundred attendees joined the first-ever Expert Answers to Community Questions on Friday 26th March to hear from a panel of experts from PHUSE, CDISC and the FDA on the topic of Data Integration & Submission Challenges.

"It was great fun to be a part of this first-ever session! Nothing like starting my morning with a group of very engaged and knowledgeable individuals talking about integration databases! Many thanks to the PHUSE team for working tirelessly to bring this to fruition and to the FDA and CDISC panellists. Great questions from those community members who attended the session!” – Aatiya Zaidi, Gilead Sciences

“Loved the event, bringing all the parties together at the same table and clarify some of the questions, concerns, issues around Data Integration & Submission Challenges” –Lisa Lin, FDA

Why Data Integration & Submission Challenges?

It is a struggle for sponsors to establish an integration strategy using standardised data and legacy data at the tabulation and/or analysis level as no specific strategy or requirements exist within the industry or regulatory agencies.

The industry continues to face challenges and hurdles with pooling, levelling, traceability, and compliance checks with regards to integration. There are currently no published industry-defined data standards for the submission of an ISS/ISE. PHUSE has also initiated a new project to develop a template, completion guidelines and example documents for an integrated DRG.

For this reason, we brought together a panel of experts to address questions from the industry on this topic and the challenges faced around data integration and submission of electronic data to the regulatory agencies.

The Live Event

Aatiya Zaidi began the event by introducing the Integration Strategies in Support of ISS/ISE Submissions, which included interactive, live polling with attendees – see the results below. Based on the PHUSE White Paper Integration Strategies in Support of ISS/ISE Submissions.

The next phase of the event was a presentation on Type C Meeting – Safety Analysis Strategy for the ISS, hosted by Nhi Beasley, Lisa Lin and Douglas Warfield. This led on to the Question Session, where our panel of experts answered eight key questions submitted by the PHUSE Community. Including:

Do we need to implement the latest requirement in the Data Standards Catalog such as use of LOINC? Or is it still recommended to be used to summarise LB data, even if the study started after 15th March 2020?

CDISC Adam Integrated Guidance is on hold – what is CDISC’s plan there?

ISS is one of the key items to be discussed with the FDA prior to the NDA, I think. Do you request a Type C Meeting to talk about ISS strategy, including legacy data conversion, and get the agreement from the FDA? Or is the item ‘ISS Strategy’ usually included in the agenda of another meeting?

Any questions that weren’t able to be answered live will be taken back to the team for review and then published on the SDTM FAQ project page on the Advance Hub – home for all things PHUSE Working Groups.

Kiran Kundarapu then gave an update on the project he is leading, the Clinical Integrated Study Data & Analysis Data Reviewer’s Guide, which falls under the Optimizing the Use of Data Standards Working Group.

The event ended with an open Q&A Session. Thank you to all who contributed to what was a brilliant first event. We had some excellent questions and insight asked and shared.

“It was my pleasure to moderate the very first Expert Answers to Community Questions (EAtCQ) event! Thank you to PHUSE for providing such a wonderful platform and a big thanks to our panel for their expert answers!

Thanks to our Community for submitting their questions and for their attendance. Great topic, great discussion and an amazing knowledge sharing session for everyone!” – Bhavin Busa, Vita Data Sciences

Catch Up On Demand

If you missed the event, or would like to re-watch, you can find the live recording on the PHUSE Archive.

Please send any follow-up questions to workinggroups@phuse.global.