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However, clinical adoption of WGS has been limited to pilot studies involving very small numbers of cases (mostly < 10 12,13,14,15,16,17 and the median turnaround time for generating the final clinical report may exceed 100 days due to mandatory secondary validation of variants by a CLIA-certified lab12,18.
We suggest that quantitative FFPE sample characterization using threshold-based metrics such as the QFI can improve the cost, efficiency, and accuracy of confirmation, and help de-risk the final clinical report.
To this end, we used the clinical study report (SKB's "final clinical report"), including appendices A-G, which are publically available on the GSK website, 9 other publically available documents, 10 and the individual participant data accessed through SAS Solutions OnDemand website, 11 on which GSK subsequently also posted some Study 329 documents (available only to users approved by GSK).
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In addition, a central database was built to archive all of the genetic testing data, notes, and comments throughout the review process, variant validation data by Sanger sequencing as well as the final clinical reports for future reference.
Only RCTs that compared insulin glargine with an active comparator and that had a final clinical study report available for review on 15 May 2009 were included in this analysis.
The maximum diameter of the resected tumour, as calculated by the pathologist, was also collated and compared to the maximum diameter recorded in the final clinical MRI report using the Limits of Agreement method proposed by Bland and Altman (1986).
GCP stipulates the clinical trial process, including protocol and Case Report Form design, analyses planning, as well as analyzing and preparing interim and final clinical trial/study reports.
In addition, each study site reported a final clinical HER2 status (negative, equivocal, or positive, and defined as local HER2 status or investigator-determined HER2 status) based on the combination of all available local HER2 results for each case.
Mesothelin levels were determined by commercial ELISA in effusions and their relationship to concurrent pathology reporting and final clinical diagnosis was determined.
A clinical report.
Final clinical evaluation.
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