| Tanmay Khole |
Addition of an open-label extension to a blinded parent study mid-study introduces significant risks to trial integrity and
requires coordinated effort across multiple functions. This case study highlights how data management, statistical
programming, and statistical teams collaborated to address complexities during study conduct, driven by evolving design
requirements.
The transition posed an immediate risk of unintentional unblinding and potential treatment disruption,
primarily due to complex randomization schema. In response, the cross-functional team rapidly implemented data
masking, dummy randomization strategies, and strict access controls to preserve the blind while ensuring uninterrupted
patient treatment.
The evolving trial design had far-reaching impacts on data operations. It necessitated updates to the
electronic data capture system, edit checks, and data transfer specifications. Metadata, SDTM & ADaM data, and
reporting logic were revised to support parallel streams of blinded and open-label data. Vendor contracts & data
integration agreements were also updated to reflect changes in scope, timelines, & deliverables.
The result was a
seamless continuation of the study without compromising scientific validity or regulatory compliance. This session
provides a practical blueprint for how cross-functional teams can manage mid-study design changes with agility, ensuring
data quality, treatment continuity, and operational consistency across the trial lifecycle. |