scholarly journals Botanical drug clinical trial: Common issues and future options

2020 ◽  
Author(s):  
Yu Sun ◽  
Jiahua Qian
Keyword(s):  
Clinical Trial ◽  
Drug Clinical Trial ◽  
Botanical Drug

Artemeter-Lumefantrine therapeutic efficacy, safety and plasma levels in patients with uncomplicated falciparum malaria from the Colombian Pacific región

Infectio ◽  
2018 ◽  
Vol 22 (4) ◽  
pp. 199
Author(s):  
Alberto Tobón-Castaño ◽  
Luisa Garcés-Murillo ◽  
Alexandra Ríos-Orrego ◽  
Jehidys Montiel-Ramos ◽  
Briegel De Las Salas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Falciparum Malaria ◽  
Therapeutic Efficacy ◽  
Plasma Concentrations ◽  
Plasmodium Falciparum Malaria ◽  
Therapeutic Failure ◽  
World Health ◽  
Blood Levels ◽  
Drug Clinical Trial ◽  
Parasitological Response

Introduction: In Colombia, the published studies for the treatment of uncomplicated Plasmodium falciparum malaria with Artemether-Lumefantrine are scarce. The aim of the study was to evaluate the therapeutic efficacy and safety profile of this combination.Methods: A clinical trial was performed in adults with uncomplicated P. falciparum malaria using the 28-day World Health Organization validated protocol. Patients received supervised antimalarial treatment and the primary efficacy endpoint was the clinical and parasitological response. Safety was assessed through adverse events surveillance and plasmatic levels of antimalarial drugs were measured.Results: 88 patients were included. Adequate clinical and parasitological response rate of 100% on day 28 was achieved in 84 patients, diagnosed by thick blood smear examination. There were four parasitological therapeutic failures (5%) detected by polymerase chain reaction.Discusion: Therapeutic efficacy similar to previous studies was established with a slight increase in therapeutic failure. The serum levels of the antimalarials were adequate and the few cases of therapeutic failure were not related.Conclusion: Treatment of uncomplicated P. falciparum malaria with Artemeter-Lumefantrine was effective and safe in the study population. All patients reached adequate plasma concentrations of the drugs; therapeutic failures were not associated with low blood levels of the drug clinical trial.

scholarly journals The appearance and increase in the quantity and proportion of the clinical research coordinator's service fee in drug clinical trial research fund and its impact on trial quality

2020 ◽  
Author(s):  
Liran Chen ◽  
Zhimin Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Structural Changes ◽  
Continuous Increase ◽  
Clinical Trial Research ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
Drug Clinical Trial

Abstract Objective: The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed.Methods: This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc.Result: The most significant appearance and increase in volume and proportion were the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500,accounted for 33.74%.Discussion: It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator.

scholarly journals The appearance and increase in the quantity and proportion of the clinical research coordinator’s service fee in drug clinical trial research fund and its impact on trial quality

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Liran Chen ◽  
Zhimin Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Structural Changes ◽  
Continuous Increase ◽  
Clinical Trial Research ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
Drug Clinical Trial

Abstract Objective The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed. Methods This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc. Result The most significant appearance of increase in volume and proportion was the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500, accounted for 33.74%. Discussion It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator. Conclusion The clinical research coordinators’ access standards, pre-employment training and examination, job and performance evaluation, in addition to the SMO specification management and avoiding malicious competition between the industry, are important factors in the quality assurance of drug clinical trials.

scholarly journals Analysis on the influence of the proportion and growth rate of different categories of drug clinical trial research funds on quality improvement in China recently six years

2019 ◽  
Author(s):  
Liran Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Quality Improvement ◽  
Clinical Trial Data ◽  
Continuous Increase ◽  
Clinical Trial Research ◽  
Drug Clinical Trial ◽  
The Cost ◽  
Self Examination ◽  
The Impact

Abstract Background: China Food and Drug Administration issued Announcement of Self-examination and Inspection of Drug Clinical Trial Data on July 22, 2015. Great change have taken place since the most stringent drug registration self-examination and inspection in history was launched, among those variety, the cost of clinical trials is one of the important changes. Methods ：The paper compare the changes in the cost of drug clinical trials on both amount and structures between 3 years before and after self-examination and inspection initiated by the CFDA ,Identify the increase number and composition, analyze the impact of the cost of new CRC, the labor service of researchers, the audit company, the institutional drug management and quality control on the quality improvement of drug clinical trials. Conclusions ： According to the article, the emergence and rise in most clinical trials costs are conducive to the quality enhancement of drug clinical trial, the occurrence and continuous increase of CRC costs improve the quality, at the same time, It implies a barriers factor to improve the drug clinical trial quality. To improve the quality of clinical trials, China must regulate the booming SMO market and formulate actively industry standards and qualification certification for CRC.

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