Clinical Trials: Ensuring Quality and Standardization

  • Mihir M. Shah
  • Darren R. CarpizoEmail author
Part of the Success in Academic Surgery book series (SIAS)


The number of clinical trials in the United States and worldwide is increasing rapidly., which started in the year 2000, registered a total of 2119 trials, whereas in 2019, that number is 309,531, which is nearly a 150-fold increase [1]. Of the 309,531 trials registered in 2019, 244,831 (79%) are interventional, with 25,857 - or approximately 11% - involving a surgical procedure. With this rise in the number of clinical trials, there is an increased need to ensure that human subjects research being conducted is done in a manner that is ethical and the data collected, analyzed, and reported are of high quality and transparent. To meet this need, organizations ranging from academic centers to large consortia that conduct clinical trials to the National Institutes of Health now have implemented training programs and defined standards for all professionals participating in the conduct of clinical trials. We will review some of these standards, as well as other components of clinical trials to ensure quality and standardization.


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Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  1. 1.Division of Surgical Oncology, Department of SurgeryEmory University SchoolAtlantaUSA
  2. 2.Division of Surgical Oncology, Department of SurgeryUniversity of RochesterRochesterUSA

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