In order to understand this disparity between human use and drugs approved by regulatory agencies,we analyzed botanical drug clinical trials registered at ClinicalTrial.gov to detect trends in current trials and guide...In order to understand this disparity between human use and drugs approved by regulatory agencies,we analyzed botanical drug clinical trials registered at ClinicalTrial.gov to detect trends in current trials and guide future trials.A total of 195 botanical drug clinical trials were registered from 2016 to2019,of which 81 are phaseⅡor phaseⅡ/Ⅲ.95%of all phaseⅡandⅡ/Ⅲstudies were designed with100 or less participants per arm,indicating a more observational nature due to the limited power to detect differences in outcomes between treatment and control groups.Due to the limited number of participants,efficacy outcome from results may be highly subjective.14%of the total trials were phaseⅠstudies.For botanical drugs with well-documented or extensive history of human use,phaseⅠmay not provide significant additional information,and may,therefore,not be necessary.For the trial design,we suggest added-on studies when botanical drugs are used as part of a combination treatment.Additionally,we believe standardized data collection methods and criteria are critical to utilizing the vast collection of human experience as quality evidence to support regulatory approval.展开更多
文摘In order to understand this disparity between human use and drugs approved by regulatory agencies,we analyzed botanical drug clinical trials registered at ClinicalTrial.gov to detect trends in current trials and guide future trials.A total of 195 botanical drug clinical trials were registered from 2016 to2019,of which 81 are phaseⅡor phaseⅡ/Ⅲ.95%of all phaseⅡandⅡ/Ⅲstudies were designed with100 or less participants per arm,indicating a more observational nature due to the limited power to detect differences in outcomes between treatment and control groups.Due to the limited number of participants,efficacy outcome from results may be highly subjective.14%of the total trials were phaseⅠstudies.For botanical drugs with well-documented or extensive history of human use,phaseⅠmay not provide significant additional information,and may,therefore,not be necessary.For the trial design,we suggest added-on studies when botanical drugs are used as part of a combination treatment.Additionally,we believe standardized data collection methods and criteria are critical to utilizing the vast collection of human experience as quality evidence to support regulatory approval.
