Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or Misconduct

Background: Traditional site-monitoring techniques are not optimal in finding data fabrication and other nonrandom data distributions with the greatest potential for jeopardizing the validity of study results. TransCelerate BioPharma conducted an experiment testing the utility of statistical methods...

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Veröffentlicht in:	Therapeutic innovation & regulatory science 2016-03, Vol.50 (2), p.144-154
Hauptverfasser:	Knepper, David, Lindblad, Anne S., Sharma, Gaurav, Gensler, Gary R., Manukyan, Zorayr, Matthews, Abigail G., Seifu, Yodit
Format:	Artikel
Sprache:	eng
Schlagworte:	Authorship Biomedical research Blood pressure Chronic obstructive pulmonary disease Clinical trials Collaboration Drug Safety and Pharmacovigilance Pharmaceutical industry Pharmacotherapy Pharmacy Quality R&D Research & development Research parks Sponsored Special Section by TransCelerate BioPharma: Original Research Statistical methods Studies
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