2016
DOI: 10.1089/adt.2016.742
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Big Data Mining and Adverse Event Pattern Analysis in Clinical Drug Trials

Abstract: Drug adverse events (AEs) are a major health threat to patients seeking medical treatment and a significant barrier in drug discovery and development. AEs are now required to be submitted during clinical trials and can be extracted from (), a database of clinical studies around the world. By extracting drug and AE information from and structuring it into a database, drug-AEs could be established for future drug development and repositioning. To our knowledge, current AE databases contain mainly U.S. Food and… Show more

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Cited by 18 publications
(16 citation statements)
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“…2 The post-processing steps include regular expressions, and a dictionary-based approach for extracting certain elds as information was entered in various formats in published results. 3 Validation of the data acquired on ClinicalTrials.gov: The reliability of the data was ensured by checking the consistency of the number of clinical trial entries in the downloaded CSV le with the retrieved results.…”
Section: Data Processingmentioning
confidence: 99%
“…2 The post-processing steps include regular expressions, and a dictionary-based approach for extracting certain elds as information was entered in various formats in published results. 3 Validation of the data acquired on ClinicalTrials.gov: The reliability of the data was ensured by checking the consistency of the number of clinical trial entries in the downloaded CSV le with the retrieved results.…”
Section: Data Processingmentioning
confidence: 99%
“…The AEs extracted from these trials span across 26 AE categories. [19] The Big Data Challenges and Opportunities:-It has been always observed that arrival of any new technology brings along with it some challenges or limitations. Similarly, Big Data also has challenges and some shortcomings as below listed [20]:- Evidence of practical benefits of big data analytics is scarce  Methodological issues, such as data quality, data inconsistency and instability, limitations of observational studies, validation, analytical issues, and legal issues exist.…”
Section: A Data Survey Was Carried Out By Scorr Marketingmentioning
confidence: 99%
“…Drug-induced gastrointestinal toxicities (DI-GITs) are the most common category of adverse events (AEs) both during clinical trials 1 and after drug approval. 2 When incidence of druginduced AEs is broken down by individual symptoms, five GI AEs (nausea, vomiting, constipation, diarrhoea, and abdominal pain) rank among the 12 most frequent.…”
Section: Introductionmentioning
confidence: 99%
“…2 When incidence of druginduced AEs is broken down by individual symptoms, five GI AEs (nausea, vomiting, constipation, diarrhoea, and abdominal pain) rank among the 12 most frequent. 1 These AEs occur across all drug modalities and span all therapeutic areas. 3 However, the consequences of GIT often differ from those in other organ systems with respect to timing of discovery, medical response, impact on drug development, and effects on patients.…”
Section: Introductionmentioning
confidence: 99%