Trends of clinical trials from 2014 to 2016 in South Korea
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MethodsClinical trials listed in the MFDS clinical trial registry from January 1 st , 2014 to December 31 st , 2016 were included in the analysis.Therapeutic areas were classified based on investigational product (IP) described in the study title by World Health Organization Anatomical Therapeutic Chemical (WHO-ATC) Classification System.If the IP code was not specified in the database, IP code was referred to ClinicalTrials.govregistry to classify therapeutic area.When reference was not found, the trial was counted as 'Other' .When IPs of different therapeutic area co-existed in a clinical trial, therapeutic area was selected in terms of relative importance considering the number of drugs and study purpose.Study phase of '0' , '1/2a' , '1/2' , '1' , '1/3' was coded as phase 1;'2/3' , '2a' , '2b' , '2' , '2b/3' was coded as phase 2; '3a' , '3b' , '3' , '3/4' was coded as phase 3; trials other than phase 1 to 4 and investigator-Keywords:
Clinical Research
The term"clinical trials"as used in the Clinical Trials Act refers to research aimed at determining the efficacy or safety of pharmaceuticals by administering them to humans. The term"specified clinical trials"as defined in this Act encompasses clinical trials that meet either of the following criteria:(i)Clinical trials funded or supported by a manufacturer with marketing approval for the pharmaceuticals or(ii)Clinical trials involving unapproved or off-label pharmaceuticals. Such research must comply with the standards established by the Clinical Research Act. The Clinical Research Subcommittee is deliberating strategies to bolster the conduct of clinical research in alignment with international standards. Discussions encompass establishing sponsors for multi-institutional collaborative research, utilizing collected data for drug application submissions, re- evaluating the legal parameters of observational studies, defining the extent of off-label use research, assessing the applicability of laws to medical devices, digitizing and simplifying notification and amendment processes, and introducing various modifications and strategies to uphold research quality. The objective is to refine the clinical research framework and enhance access to pertinent information.
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Recent controversies over the protection of human subjects, payment of physicians for recruiting patients to clinical trials, Food and Drug Administration (FDA) removal of approved drugs from the market, and reporting of results of clinical trials have highlighted important facets of clinical research. Less visible has been the industrialization of clinical research, and especially of clinical trials, that is, its emergence as a "line of business" of substantial magnitude and rapid growth. The growth of drug-industry outsourcing of clinical trials and the concomitant rise of a contract research industry are described in this paper, which argues for greater transparency in the conduct of both publicly and privately sponsored clinical trials.
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The new Clinical Trials Act that recently came into effect in Japan emphasizes the reliability of investigator-initiated clinical trials. Although Japanese clinical research coordinators have been mainly engaged in operational roles in industry-initiated clinical trials for drug approval (registration trials), broadening their contribution to cover more types of clinical research may lead to quality improvement of clinical research. To ultimately establish a clinical research infrastructure that meets the needs of the new era of Clinical Trials Act, here we gathered basic information on how clinical research coordinators might make such contributions.We conducted a survey using self-reporting questionnaires in clinical research-related personnel to examine present status and the perspectives toward broader contribution of clinical research coordinators. The study participants were attendee of group discussion of a clinical research-related meeting in Shikoku area of Japan held in August 2017.Among 88 participants, 69 responded (response rate: 78.4%) and 68 respondents (98.6%) were engaged in support and management of clinical research. The main area of involvement was industry-initiated registration trials (48, 69.7%), and main roles of involvement were cooperators who plays roles under the guidance of investigators (41, 59.5%). When divided by occupation into clinical research coordinators (n = 41) and other clinical research-related personnel (n = 28), approximately half of the respondents in each group replied positively to wanting broader involvement of clinical research coordinators as a clinical research professional.The present study revealed that about half of the clinical research coordinators and other clinical research-related personnel view a broadening of involvement of clinical research coordinators in research activities positively. Accordingly, a structured practical program aimed at encouraging such involvement may help to expand and strengthen their contribution into the future. Whether greater involvement of clinical research coordinators in clinical research will help to ensure the reliability of investigator-initiated clinical research warrants further study.
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The number of clinical trials in Japan is decreasing following the new GCP enforcement. For the promotion of clinical trials, establishment of a clinical trial enforcement system which meets the investigators and the sponsors' expectations, is necessary. We questioned the investigators and sponsors about problems in the clinical trial enforcement system and the function of the clinical research coordinator (CRC) in Nagasaki University Hospital. The results suggested that investigators and sponsors need assistance from CRC for a large portion of their clinical trial practices. It was noteworthy that when a sponsor applies for clinical trials to hospitals or clinics, the most important problem is the complexity of the document related to the clinical trial. The investigators and the sponsors need to be aware that a low number of participants prevents the progress of clinical trials. In addition, it was suggested that an economic incentive given to the investigators for clinical trial promotion is desirable
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The National Institute on Deafness and Other Communication Disorders (NIDCD) embarked on the establishment of two clinical trials cooperative groups in October 1996 in response to a scientific research need. It intended that the clinical trials cooperative groups (CTCGs) design and implement clinical trial protocols capable of addressing the efficacy of therapeutic interventions for diseases and disorders of human communication. Most commonly, owing to the substantial number of patients required, the trials are expected to involve multiple study sites, with each study site adhering to a uniform study protocol, standardized treatment regimens, and prescribed data collection procedures. A complex administrative structure is required to coordinate the activities of the CTCGs and to assure compliance with a myriad of government regulations. Similarly, participating study sites must meet stringent requirements including leadership by an individual experienced in clinical trials. There is a relative dearth of experienced clinical trialists dedicated to research in human communication. This article details the complexities involved in the conduct of multicenter clinical trials and the NIDCD's efforts to promote clinical trials activities and to develop clinical trials training opportunities.
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Research Design
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Clinical trials are of paramount importance for the development and evaluation of new therapies for patients with human immunodeficiency virus (HIV) disease. The objective of an HIV clinical research unit is to conduct high quality clinical research with patients who have HIV disease. The conduct of these research studies requires accurate and complete data collection. Coordination of the patients' primary care must be complemented by a working knowledge of the relevant ethical issues. In addition, technical, managerial, and clinical expertise is needed for conducting the trials and collecting data. To accurately plan the research, personnel and resource allocation should be periodically assessed. Clinicians, particularly those who have not previously conducted clinical trials or who are considering the incorporation of a research program into a primary care setting, must be familiar with these issues in order to create and supervise this type of clinical research unit. A smoothly running clinic observing a defined cohort of patients is attractive to government agencies and pharmaceutical sponsors for funding of clinical trials and research projects.
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In order to carry out unitary management for the clinical trials of investigational drugs under Good Clinical Practice, the Center for Clinical Trial and Clinical Research was established at the Nagoya University Hospital in November 1998. Further, the clinical research coordinators (CRC) were organized in April 1999, and the general support of the clinical trial operation was started. Although it is well known that the involvement of CRC in clinical trials is necessary and important, the effect remains unclear. Thus, we evaluated the roles of CRC in the clinical trials of investigational drugs for rheumatic outpatients.The role of CRC includes assistance to obtain the informed consent, and to fill out the case report form, as well as management of the schedule. It was found that the rate of the consent acquisition from patients was significantly increased from 60.0% to 95.2% when CRC was involved. Further, the time to obtain agreement to enter into the clinical trials was significantly shortened and the rate (100.0%) of entry into the clinical trials supported by CRC was also higher than that (66.7%) in trials not supported by CRC.These results suggest that the informed consent from the patients can be obtained more easily when CRC is involved in clinical trials, and that such involvement of CRC contributes to an increase in the rate of entry of patients into the clinical trials and the speeding-up of the clinical trial enforcement.
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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.
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The Clinical Research Networks of the National Institute of Health Research have transformed clinical research in the UK, leading to a doubling in the number of patients involved in clinical research studies over the past 3 years. This has been achieved by streamlining the trials approvals process, by providing local infrastructure such as research nurse support for clinical trials recruitment and through recognition of the time and funding necessary for clinicians to contribute to clinical research. Here, we describe the structure and roles of the Comprehensive Clinical Research Networks in gastrointestinal disease and hepatology, particularly in England. We will explain how the networks have already accelerated clinical research in gastrointestinal and liver disease, as well as provide a simple guide about how individual clinicians can contribute to ongoing studies via the networks.
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