To introduce the international registration condition of acupuncture clinical research. With the examples of World Health Organization International Clinical Trials Registry Platform and the U. S. National Institutes of Health Clinical Registration Platform, the registration method and current condition of acupuncture clinical trials in international clinical trials registration platform were analyzed. The results indicate that the number of acupuncture clinical trials registration is gradually increased and the registration number from China is on the rise as well. But most domestic acupuncture clinical researches haven't been registered arid the researchers' valuing degree for clinical trials registration and methodology research needs to be improved.
Acupuncture Therapy ; standards ; Biomedical Research ; legislation & jurisprudence ; standards ; Clinical Trials as Topic ; legislation & jurisprudence ; standards ; Humans ; Registries

This article introduces the clinical requests of indigenous diagnostic imaging ultrasound devices in first-time registration application and the clinical trial requests in Technical Review Guidance of Ultrasound Imaging Diagnostic Devices (category III) Registration and puts forward some questions of the guidance's implementation. It is hoped to help concerned people.
China ; Clinical Trials as Topic ; standards ; Device Approval ; legislation & jurisprudence ; standards ; Guidelines as Topic ; Ultrasonography ; instrumentation

With the active encouragement of the Chinese government, all domestic clinical research institutes pay more attention to the human research protect program (HRPP) during the process of clinical trials, and actively follow the regulations of medical ethical practice. We could make fully preparation for the accreditation by the correlated international organizations only by further analyzing the Association for Accreditation of Human Research Protection Program (AAHRPP) from a whole and in each accreditation field at different levels, thus having a clear understanding the difference in acknowledging the difference between China's hospitals and America's hospitals.
Accreditation ; China ; Clinical Trials as Topic ; legislation & jurisprudence ; Humans ; Public Policy ; United States

In 2012, USA Food and Drug Administration (FDA) approved 39 new drugs, however, there are only two botanical drugs (one topical and one oral) approved by FDA since the publication of the FDA's industry guidelines for the botanical drug product in June 2004. The approval shows the Western guideline can be used for herbal medicines, authors investigate current regulation on herbal medicine clinical research, identify challenges conducting clinical trials, and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area. Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials. Authors critically explore case study of the 1st FDA approved botanical drugs, Veregen (sinecatechins), green tea leaves extract, a topical cream for perianal and genital condyloma. In consideration of current regulation environment in USA, based on the findings and analysis through the literature review and Veregen case study, authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considering in a herbal medicine clinical trial.
Biomedical Research ; legislation & jurisprudence ; Clinical Trials as Topic ; Herb-Drug Interactions ; Herbal Medicine ; legislation & jurisprudence ; Humans ; Plants, Medicinal ; adverse effects ; United States

The institutional review board is crucial to ensure the scientific and ethical quality of human participant research. This paper analyzes a survey on the current constitution and operation of institutional review boards (IRBs) in Korea, conducted by the Korean Association of Institutional Review Boards in April 2002. Out of 74 IRBs, 63 responded to the survey (85.1% response rate). IRB membership has a male-to-female ratio of approximately 80:20, a predominance of male clinicians (60%) and an underrepresentation of community people unaffiliated to the institutions (less than 10%). Most IRBs (around 80%) confine the scope of their reviews to the clinical evaluation of drugs or devices, leaving the remaining areas of research involving human participants untouched. As their role is limited, the majority of IRBs do not operate actively: 72% of responding IRBs reviewed less than one protocol per month in 2001. Sixty two percent of institutions have never discussed the need for insuring research participants' risks or making indemnity arrangements. This survey reveals many shortcomings and points for improvement by the institutional support bodies, including the need to establish regular education programs for IRB members and investigators.
Appointments and Schedules ; Clinical Trials/legislation & jurisprudence ; Clinical Trials/standards ; Data Collection ; Epidemiologic Studies ; Ethics Committees, Research*/legislation & jurisprudence ; Ethics Committees, Research*/standards ; Ethics Committees, Research*/statistics & numerical data ; Female ; Human ; Human Experimentation/legislation & jurisprudence ; Human Experimentation/standards ; Korea ; Male ; Politics ; Public Policy ; Research Design/standards

OBJECTIVETo analyze reasons for disapproval of registration application of new traditional Chinese medicines in recent years and discuss potential problems occurring in R&D and registration administration of new traditional Chinese medicines in China.

METHODAll applications of new traditional Chinese medicines for registrations that had been disapproved by Center for Drug Evaluation of State Food Drug Administration from 2006 to 2008 were searched in data bank. Specific reasons for disapproval of each variety were inquired and sorted out. The statistics involved the proportion of each type (kind) disapproval reasons in all disapprovals in order to analyze which were the main reasons. The results were analyzed to find out potential problems occurring in R&D and registration administration of new traditional Chinese medicines in China.

RESULTThere were totally 247 disapproved registration applications for new traditional Chinese medicines. Among them, there were 218 applications for clinical trials and 29 applications for launch in the market There were 9 categories (29 types) of reasons for the applications for clinical trials applications, mainly including such problems as R&D proposal, non-clinical effectiveness and non-clinical safety; while there were 5 categories (9 types) of reasons for the applications for launch in the market, with clinical effectiveness as the main reason.

CONCLUSIONThere were many kinds of reasons for the disapproval registration applications of new traditional Chinese medicines in recent years in China, mainly including such problems as effectiveness, safety and proposal basis. This reflects problems occurring in R&D and registration administration of new traditional Chinese medicines in China to some extent.

Animals ; China ; Clinical Trials as Topic ; Drug Approval ; legislation & jurisprudence ; organization & administration ; Drug Therapy ; Drugs, Chinese Herbal ; adverse effects ; pharmacology ; standards ; Humans ; Medicine, Chinese Traditional ; adverse effects ; standards ; Phytotherapy

Traditional Chinese medicine (TCM) injection's safety problems has been paid attention for the country and people, TCM injection's labels described the adverse reactions always shows "unclear" or blank, especially the adverse drug reactions(ADR) rates hardly reported. To save the problem, large-scale safety surveillance of TCM injection research is very important. The article introduces the research aim, research type, simple size, outcomes and ethic problem during make the plan. It is a multi-center, large sample size, registry research program about TCM injections safety monitoring. The aim is to get the ADR's rate of TCM injections. According to the "three rules" , each of the TCM injection will be observed for 30 000 cases which are inpatients. The research adopt to using the barcode system and hospital information system(HIS) & laboratory information management system(LIS) to make sure enroll all patients. Case report file (CRF) is used for record patient's information which contained 3 types(A, B, C) tables. Most of people just need to fill table A, and the patient need to fill table B when they have ADR. The outcome of the research is severe ADR. Abide by the international ethical principle to keep the patient's right.
Biomedical Research ; standards ; China ; Clinical Protocols ; standards ; Clinical Trials as Topic ; Drug Therapy ; standards ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Humans ; Medicine, Chinese Traditional ; standards ; Outcome Assessment (Health Care) ; legislation & jurisprudence ; standards

The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.
Clinical Trials as Topic ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; adverse effects ; chemistry ; economics ; therapeutic use ; Herbal Medicine ; economics ; legislation & jurisprudence ; Humans ; Patents as Topic ; Product Surveillance, Postmarketing ; Quality Control

For over 100 years, controlled human infection (CHI) studies have been performed to advance the understanding of the pathogenesis, treatment and prevention of infectious diseases. This methodology has seen a resurgence, as it offers an efficient model for selecting the most promising agents for further development from available candidates. CHI studies are utilised to bridge safety and immunogenicity testing and phase II/III efficacy studies. However, as this platform is not currently utilised in Asia, opportunities to study therapeutics and vaccines for infections that are important in Asia are missed. This review examines the regulatory differences for CHI studies between countries and summarises other regulatory differences in clinical trials as a whole. We found that the regulations that would apply to CHI studies in Singapore closely mirror those in the United Kingdom, and conclude that the regulatory and ethical guidelines in Singapore are compatible with the conduct of CHI studies.
Asia ; Clinical Trials as Topic ; economics ; standards ; Communicable Disease Control ; Communicable Diseases ; epidemiology ; Cost-Benefit Analysis ; Ethics, Medical ; Health Policy ; Humans ; Infectious Disease Medicine ; legislation & jurisprudence ; standards ; Quarantine ; Research Design ; standards ; Singapore ; United Kingdom