PHUSE EU Connect

Presenters: Jeffrey Abolafia, Director of Product Innovation

There is a rapid increase in the use of RWD to support marketing applications. However, submitting RWD may pose numerous challenges for regulatory reviewers in their analysis of the data. In our five previous papers, we outline these challenges and present several high-level solutions. This current paper builds on our previous work by taking a deep dive into CDISC SDTM example data and highlighting updates needed to the SDTM to better accommodate RWD. Specifically, we examine the gaps in the Subject Visits domain for its use in regulatory review.

Considering how other models such as HL7 FHIR, OMOP, and PCORnet handle certain elements, we propose updated domains and data elements to represent patient encounters that are a key component of RWD. These ideas are intended to help sponsors submit RWD and to continue the conversation with SDOs such as CDISC around the updates needed for more efficient regulatory review.

Presenter: Kristin Kelly, Senior Principal CDISC Consultant

Though the CDISC SDTM Implementation Guide provides advice on how to prepare SDTM datasets for completed studies, there is little guidance on what to do when the study is ongoing, leading to varied implementation practices across the industry.

At times, it may be difficult for a regulatory reviewer to readily determine that a study is still in progress without looking in the Clinical Study Data Reviewer’s Guide (cSDRG). The recent addition of the ONGOSIND (Ongoing Study Indicator) parameter in the FDA Study Data Technical Conformance Guide (sdTCG) allows sponsors to clearly specify within the data whether a study is ongoing.

In this paper, some considerations for preparing domains such as Demographics (DM), Disposition (DS), and Trial Summary (TS) for an ongoing study as well as strategies to ensure data transparency across the SDTM submission package will be discussed.