Validating electronic source data in clinical trials

The second used whole genome sequencing to identify larger genome rearrangements that can lead to tumor development.

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Grail tried out three methods on a substudy of about 1,600 people, about half who had been newly diagnosed with 10 different tumor types, and half cancer-free controls.The first test looked at changes in about 500 cancer-related genes.Key to that detection is a virus associated with the disease—Epstein Barr.Tumor cells all carry bits of the viral DNA inside them, which can easily be picked up via sequencing.While investors might be bullish on the risky venture, many oncologists have been more skeptical about how well Grail’s technique might work.

A spinout of DNA sequencing giant Illumina, the company aims to detect cancers symptoms appear by using “high-intensity” sequencing to pick out genetic material shed by lurking tumors into the bloodstream.It found lymphoma and myeloma with slightly less accuracy.It was worst at detecting breast cancer, getting it right less than a quarter of the time..Eliminating source data checks that do not add value to the study is certainly a breakthrough for trials where we have historically performed 100 percent data verification.After all, why verify data that we already know to be correct, and is a low risk to the study as well?Grail is launching that test later this year in Hong Kong—it will be the first liquid biopsy test marketed for early detection.