Identification of Common Data Elements from Pivotal FDA Trials.
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ABSTRACT:
SUBMITTER: Mayer CS
PROVIDER: S-EPMC8075437 | biostudies-literature | 2020
REPOSITORIES: biostudies-literature
Publications
Identification of Common Data Elements from Pivotal FDA Trials.
Mayer Craig S CS Williams Nick N Huser Vojtech V
AMIA ... Annual Symposium proceedings. AMIA Symposium 20200101
It is difficult to arrive at an efficient and widely acceptable set of common data elements (CDEs). Trial outcomes, as defined in a clinical trial registry, offer a large set of elements to analyze. However, all clinical trial outcomes is an overwhelming amount of information. One way to reduce this amount of data to a usable volume is to only use a subset of trials. Our method uses a subset of trials by considering trials that support drug approval (pivotal trials) by Food and Drug Administrati ...[more]
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| S-EPMC8192005 | biostudies-literature
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