caa a22 4500 605466068 CHVBK 20210128100305.0 cr unu---uuuuu 210128e20151001xx s 000 0 eng 10.1007/s00769-015-1145-0 doi (NATIONALLICENCE)springer-10.1007/s00769-015-1145-0 Krouwer Jan Krouwer Consulting, 26 Parks Drive, 01770, Sherborn, MA, USA aut Biases in clinical trials performed for regulatory approval [Elektronische Daten] [Jan Krouwer] Method comparisons are routinely performed in hospital laboratories as part of the regulatory approval process. These trials are often biased in several ways. There is often a conflict of interest bias because the hospital is paid for the trial by the manufacturer of the assay. Moreover, the trial itself is often conducted in a way that is different from routine use. The reagents selected for the trial cannot be randomly selected from all possible reagents since future reagents do not exist. Yet, future reagents often have new lots of raw materials and/or changed manufacturing procedures, which can affect assay trueness. User error is often minimized because the user chosen to perform the study receives more training then would be routinely provided. All of these factors can lead to better performance in the regulatory evaluation then performance seen after release for sale as shown by examples for glucose meters. The above biases are largely unavoidable. Steps are suggested to reduce the above biases. Springer-Verlag Berlin Heidelberg, 2015 Method comparison nationallicence Clinical trial nationallicence Bias nationallicence Regulatory approval nationallicence FDA nationallicence Accreditation and Quality Assurance Springer Berlin Heidelberg 20/5(2015-10-01), 437-439 0949-1775 20:5<437 2015 20 769 https://doi.org/10.1007/s00769-015-1145-0 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s00769-015-1145-0 text/html Onlinezugriff via DOI NATIONALLICENCE 100 1- Krouwer Jan Krouwer Consulting, 26 Parks Drive, 01770, Sherborn, MA, USA aut NATIONALLICENCE 773 0- Accreditation and Quality Assurance Springer Berlin Heidelberg 20/5(2015-10-01), 437-439 0949-1775 20:5<437 2015 20 769