Sun, Yu
Qian, Jiahua
Scientist, Chief
2020-08-25T19:50:57Z
2020-08-25T19:50:57Z
2020
2211-3835
https://doi.org/10.1016/j.apsb.2020.08.003
http://hdl.handle.net/20.500.12010/12244
Botanical drugs are plant-derived, complex mixtures which may have synergistic effects.
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 to
2019, of which 81 are phase II or phase II/III. 95% of all phase II and II/III studies were designed
with 100 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
phase I studies. For botanical drugs with well-documented or extensive history of human use, phase I
may 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.
8 páginas
application/pdf
eng
Acta Pharmaceutica Sinica B
reponame:Expeditio Repositorio Institucional UJTL
instname:Universidad de Bogotá Jorge Tadeo Lozano
Traditional Chinese medicine (TCM)
Botanical drug
Clinical trial
Real-world evidence (RWE)
Randomized-controlled trial (RCT)
Botanical drug clinical trial: common issues and future options
Artículo
Síndrome respiratorio agudo grave
COVID-19
SARS-CoV-2
Coronavirus
info:eu-repo/semantics/openAccess
info:eu-repo/semantics/acceptedVersion
Abierto (Texto Completo)
https://doi.org/10.1016/j.apsb.2020.08.003
http://purl.org/coar/resource_type/c_2df8fbb1