Ethnic factors clinical trials

Detailed sub-analyses of a variety of clinical trials have provided information about host and viral factors influencing the virologic response in the treatment of chronic hepatitis C. The most important factors include the HCV genotype, HCV RNA concentration at baseline, age, weight, gender, ethnicity, liver enzymes, and stage of fibrosis (Mihm et al. 2006 Pawlotsky 2005). 

Foreign clinical results are acceptable except in areas where there are immunological and ethnic differences between Japanese and foreigners. The ethnic factors are divided into two components intrinsic factors such as racial factors and physiological differences and extrinsic factors, which include cultural and environmental issues. In these cases, the MHLW may require that some bridging comparative clinical trials be performed with dose ranging protocols. This will enable absorption, distribution, metabolism, and excretion studies to be carried out on Japanese individuals and provide better dosage and indication for the Japanese people. The MHLW also requires that application be accompanied by one year of real-time stability data and that sterility test results be included. 

Efficacy Nine topic headings—Clinical Safety, Clinical Study Reports, Dose-Response Studies, Ethnic Factors, GCP, Clinical Trials, Clinical Evaluation by Therapeutic Category, Clinical Evaluation, Pharmacogenomics total of 18 guidelines... 

Japan has adopted the ICH GCP guidelines for clinical trials since 1997. It upholds the Helsinki Declaration to ensure the rights, welfare, and privacy of subjects are protected in clinical trials. Japan accepts foreign clinical trials, but bridiging trials may need to be performed to take into consideration effects of ethnic factors. 

The influence of ethnic factors on drug responses in clinical trials is important in two contexts. First, the regulatory application should contain data that is generated from subjects whose ethnic mix is in proportion to that in the population where the medicinal product will be used. Second, an applicant may wish that data generated in one country with one ethnic predominance should be used to gain marketing approval in another country where the ethnicity of the population is different. 

The influence of ethnic factors on drug responses in clinical trials is... 

Susceptibility factors Genetic Race and ethnicity affected adverse reactions in patients taking buprenorphine in a study using data collected by the National Institute of Drug Abuse Clinical Trials Network in 724 participants (558 non-Hispanic Caucasians,... 

El clinical safety for drugs used in long-term treatment E3 clinical study reports E4 dose—response studies E5 ethnic factors E6 good clinical practice E7 clinical trials in geriatric population... 

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