PHASE III asthma study

CASE STUDY

PHASTAR was engaged to rescue another CRO’s reporting of a large phase III study in mild asthmatics to evaluate the efficacy and safety of the experimental compound. With a primary objective to prove superiority in asthma control, analyses consisted of a complex primary endpoint and a broad range of secondary endpoints which are typically observed in respiratory.

The sponsor had dataset standards in place and PHASTAR was required to have all non-standard variables approved by the sponsor’s standards committee. All dataset programming was validated using Pinnacle 21 tools, and the CRT package was produced by PHASTAR. Due to a complex and composite primary endpoint, several sensitivity analyses were requested involving complex and novel analysis methods. PHASTAR worked in a collaborative manner with the client throughout these tasks to ensure a high-quality deliverable with fit-for-purpose results to be included in the CSR; of which PHASTAR too played an active role in the interpretation.

Throughout the course of the study several ad-hoc analyses were requested to support the CSR and publication of results. Typically, the client’s preference is to carry out these tasks in-house. However, they felt PHASTAR would be well suited to carry out these tasks which reflects the high level of trust and confidence they have in our programming and analytical ability as well as our ability to respond to changes during a study. The sponsor requested programmed narrative templates: PHASTAR delivered RTF documents according to the sponsor’s template, programmed in SAS, enabling medical writers to easily produce the final CSR narratives.

Following the successful work on this trial PHASTAR won a further stream of reporting efforts for the experimental compound: A summary of clinical safety and efficacy (SoCS/SoCE); support for additional work for Payer (e.g. NICE) submissions for the compound, and a subgroup analysis report on the subset of Asia and China patients. For all of these studies, PHASTAR provided all outputs to support this report after the main delivery and generated all necessary datasets and documentation to support a CDISC compliant delivery package.

PHASTAR has developed a substantial and experienced study team through exposure to a wide range of late-stage clinical trials in respiratory, with proven examples of high-quality deliverables and consistently meeting timelines.

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