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GCP has become the gold-standard for clinical research; initiated as a guideline pertaining to new drug development, it became a law in many countries, extending its scope to include all research. GCP is an excellent document that outlines the responsibilities of stakeholders involved in clinical research. Widely acclaimed, and deservedly so, it is considered as the “go-to” document whenever questions arise during the conduct of a clinical trial. This article presents another narrative, one that has not been articulated so far. Irrespective of whether we consider GCP as a law or a guideline, it is viewed as an “official” document, without the overt realisation that this was actually an initiative of the pharmaceutical industry, the “masters of mankind”. While the stress on documentation and monitoring in GCP was justified, its over-interpretation led to increased costs of clinical trials, with the result that smaller companies find it difficult to conduct the already expensive trials. GCP as an idea is now so entrenched within the scientific community that the real aims which led to its birth and that can be mined from the ICH website, like the need for market expansion, have remained largely unnoticed and undocumented, and are being expressed here.
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Pharmaceutical regulatory schemes concerned with real world data have been changing remarkably in terms of both drug development and post-marketing.As for drug development, ICH proposed “GCP Renovation” , which includes modernization of E8 Guideline (General Consideration for Clinical Trials) and subsequent renovation of E6 Guideline (Good Clinical Practice). It covers pragmatic clinical trials, randomized controlled trials using patient registry data, and even observational studies using real world data. In the US, “The 21st Century Cures Act” refers to the proposal concerning speeding up the approval review by making clinical trials more efficient. In fact, there are some cases where real world data was used in the approval review of expanding the application. Also, in Japan, Clinical Innovation Network (CIN) plan was announced, and utilizing the natural history data like patient registry as the control group of clinical trials for the approval review is now under consideration.As regards post-marketing surveillance, “Conditional & Accelerated Approval” (October 20, 2017, Yakuseiyakushinhatsu 1020 No. 1) stated that post-marketing confirmation of validity of efficacy and safety using real world data, such as Medical Information Database Network (MID-NET) project and patients registries in CIN plan, is required to get the early approval. Moreover, “The Ordinance on Good Post-Marketing Practice” (October 26, 2017, MHLW Ordinance No. 116) newly provided “Post-marketing Database Study” , which is conducted by use of medical information database like MID-NET, and utilizing real world data for post-marketing safety monitoring began.
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Objective:To summarize the opportunities,challenges and countermeasures that China Food and Drug Administration (CFDA) joining ICH-GCP will bring to the construction of ethics committee,so as to provide reference for the standardization construction and review ability of ethical committee in China.Methods:We reviewed and comprehensively analyzed the domestic literatures about the requirement for ethics committee after CF-DA join ICH-GCP.Results:CFDA joining ICH-GCP was conducive to speeding up the construction of Chinese ethics committee.Aiming at the challenge of the standardization construction of ethics committee,it could use the revised policy regulations and guidelines to integrate with ICH-GCP,establish ethics certification system in line with the national condition,clear the composition of members,standardize operational procedures,and establish regional ethics committee and leader the review of the unit system;to improve the review ability,it could strengthen reviewing requirement from the aspects of sponsor responsibilities,researchers qualification,research protocols,informed consent,researcher brochures and documents management.Conclusion:CFDA joining ICH-GCP brings a rapid development opportunity for the ethics committee as well as challenges.We can solve problems from standardization construction and the improvement of review ability,to speed up the construction of ethics committee that meets the requirements of ICH-GCP.
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The roles of pharmacists in clinical trials including GCP training , drug administration , evaluation of drug safety issues in clinical trials and regimen design etc were discussed and prospected in the paper .The roles of pharmacists are decisive , and they will play more important roles in clinical trials .
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Objective To investigate the mastery degree of GCP (Good Clinical Practice) in Guang’anmen Hospital of China Academy of Chinese Medical Sciences (hereinafter referred to as“Guang’anmen Hospital”). Methods Totally 338 clinical researchers, covering 18 clinical professional sections and medical clinical trial institutions, in Guang’anmen Hospital with both qualification of clinical trials and GCP certificate were investigated in 23th-27th June 2014. The investigation was in the written answer sheet form, including four noun explanations and 36 multiple choice questions, which were related to GCP. Results 338 researchers could accurately explain the concepts of 4 nouns, and 57 (16.86%) researchers could do all multiple choice questions correctly. 141 (41.72%) researchers chose 1 wrong answer and 89 (26.33%) researchers chose 2 wrong answers. 39 (11.54%) researchers failed to answer 3-4 questions. Only 12 (3.55%) researchers failed to answer 5 or more questions. Conclusion The mastery degree of clinical researchers with qualification of clinical trials and GCP certificate in Guang’anmen Hospital is satisfied. In the future, pertinence and diverse training should be strengthened, in order to improve the overall level of the mastery degree of GCP.
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Objective To study the scientificity and rationality in data management of the project of Chinese Chronic Disease Clinical Research System and its Achievements Application Mode;To provide evidence and reference for the improvement of follow-up work. Methods According to the relevant management regulations, guidelines, and other relevant documents of national and international clinical research data,“Questionnaire for Research Data Management Assessment of Chinese Chronic Disease Prevention” was designed. The questionnaires were used in 10 clinical topics during the on-site inspection survey, and 20 valid questionnaires were retrieved and analyzed statistically. Results 50-60 percentage of subjects in data management and statistics were performed by the third party;70 percentage of subjects were performed by their own central monitoring;50 percentage of the subjects adopted a cooperative manner with others to develop appropriate data management systems;7 centers had system and plan for data management;Data management was carried out;implementation degree of training, database, CRF tracing, and others 7 aspects was low. Conclusion Improving the quality of data management of TCM clinical research still needs to be perfected from many aspects, and quality mode of large-scale clinical trials should be improved.
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Introducción: El entorno regulatorio mundial es cada vez más exigente para establecer, implementar y mantener el cumplimiento de las buenas prácticas clínicas (BPC). En Cuba, una respuesta necesaria derivada del desarrollo creciente de la industria farmacéutica y biotecnológica nacional fue la creación del Centro Nacional Coordinador de Ensayos Clínicos (CENCEC). Una de las misiones del CENCEC es preparar a las unidades-sitios clínicos seleccionados que realizan investigaciones clínicas, para su posterior certificación en BPC por la autoridad reguladora nacional, con la finalidad de avalar la calidad que corresponde al proceso de investigación clínica que redunda en una esmerada atención y protección al paciente objeto de estudio. Objetivo: Describir la estrategia del CENCEC para la preparación en BPC de los sitios clínicos seleccionados del Sistema Nacional de Salud (SNS) que participan en ensayos clínicos. Métodos: Se revisan más de 250 documentos normativos emitidos por Europa, Estados Unidos, Japón y los países nórdicos relacionados con aspectos prácticos y éticos para la implementación de las BPC...
Background: The global regulatory environment is increasingly demanding to establish, implement, and maintain the compliance with Good Clinical Practices (GCP). In Cuba, The National Coordinating Center for Clinical Trials (CENCEC) was created as a necessary response derived from the increasing development of the national pharmaceutical and biotechnological industry. One of the missions of the CENCEC is to prepare selected clinical units/sites that conduct clinical research for a further certification in GCP by the national regulatory authority in order to guarantee the quality that corresponds to the process of clinical research, resulting in a careful attention and protection of the patient under study. Objective: To describe the strategy of the CENCEC for the preparation of good clinical practices in the selected clinical sites of the National Health System (SNS) that participate in clinical trials. Methods: More than 250 regulatory documents issued by Europe, the United States, Japan and the Nordic countries, related to ethical and practical aspects for the implementation of good clinical practices, were reviewed...
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Clinical Trials as Topic/methods , Practice Guidelines as Topic/standards , Health Facilities/standards , Evidence-Based Practice/methods , Enacted StatutesABSTRACT
This study was aimed to construct a clinical trial technological platform of traditional Chinese medicine (TCM) live disease in accordance with the international good clinical practice (GCP) standard. Through the con-struction of technological platforms such as clinical new medicine ethics committee of liver disease of TCM, ex-perimental methods, curative effect evaluation, data management, and etc., the clinical evaluation method and in-dex system of new drugs with the curative effect characteristics of liver disease of TCM were established. It was concluded that under the construction of relevant technological platform, an effect evaluation method and index system with TCM diagnosis and treatment characteristics were built . And a key clinical trial technological platform of new drugs of TCM liver disease was established to meet requirements of the international GCP standard.
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Medical workers are the main designers and participants of clinical trials.In this consideration,popularization of good clinical practice (GCP)knowledge among them can improve their execution of trials,standardize basic clinical trial requirements,protect legitimate rights and health/safety of the subjects,and make the trial results more reliable.These objectives,if accomplished,will upgrade the clinical trials competency of medical institutions in China,and encourage healthy growth of the medical and pharmaceutical industry.The paper probed into the occupation qualification system of clinical trial workers and their supervision mechanism,inclusion of GCP into the continuing education system.
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In this report, we introduce the importance of a system for sharing information about cancer molecular-targeted medicines from trial to the clinic by the department of knowledge education research, department of breast surgical oncology, department of cardiovascular internal medicine and department of dermatology at St. Luke’s International Hospital in Japan. At present, information regarding the side effect(s) of a study drug does not reach doctors who are not members of the department in charge of the clinical trial. The reason for this is because clinical trials are conducted under the legal constraints of GCP (Good clinical practice), and while safety information about any adverse events (side effects) is reported, it is limited to the level of an Institutional Review Board. When there was an enquiry about a known side effect that had occurred to patients taking molecular-target medicine from a doctor who was not a member of the department in charge of the clinical trial, it became clear that information regarding the clinical trial medicine and non-approved medicine was not reaching the clinic. We developed an original reporting system for such information that would offer the information using the same format as the clinical trial itself, as well as the department in which the side effect was treated, to resolve the problem of access to side effect information outside of the clinical trial itself. We show that the reporting of such information leads to resolution of this problem. We believe that this will relieve the patient and contribute to the clinical trial as well as to the department that deals with such side effects.
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Clinical research is a necessity, not an option, for developing better and new medicines and therapeutic modalities. But in the course of clinical research, there are rules and guidelines that should be followed to ensure the due respect for persons, beneficence, and justice for persons who voluntarily participate in the research as described in the Belmont Report. Good Clinical Practice (GCP) is an "international scientific and ethical quality standard for designing, conducting, recording, and reporting" clinical trials. The main purposes of GCP would be to protect rights, safety, and well-being of trial subjects, in compliance with the principles of Declaration of Helsinki, and to assure that the data obtained from clinical trials are credible. In order to achieve these, investigators must be fully aware of the meanings as well as actual procedures involved in the research and should make the best effort to comply with GCP. For those individuals who belong to vulnerable populations, such as neonates, in addition to the general principles of GCP, further measures to ensure added protection should be implemented. It is our duty to develop and provide better care through clinical research even for neonates. But in doing so, we have to make sure that the importance of protecting the rights, safety, and well-being of the subjects supersede the interests of science and society.
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Humans , Infant, Newborn , Beneficence , Compliance , Dietary Sucrose , Helsinki Declaration , Human Rights , Research Personnel , Social Justice , Vulnerable PopulationsABSTRACT
OBJECTIVE:To provide references for improving the quality of clinical trial of new drug (phase I-IV),guaranteeing participants' interests and enhancing the core competitive power of drug clinical trial institutions. METHODS: The advantages of both the guiding principle of Good Clinical Practice(GCP) and the quality standards of ISO/IEC17025:2005 were applied throughout the quality control process of clinical drug trial. RESULTS & CONCLUSIONS: To establish quality management and supervision system in China that is in line with the international norm and national condition by combining GCP principle with the quality standards of ISO/IEC17025 is conducive to the improvement of the quality of clinical drug trial and enhancement of the core competitive power of drug clinical trial institutions in China.
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OBJECTIVE:To discuss the role of hospital pharmacists in the clinical drug trial.METHODS:The role of hospital pharmacists in publicizing and training of Good Clinical Practice(GCP),in the formulation of each standard operating instruction and in each stage of clinical drug trial was analyzed.RESULTS&CONCLUSION:Hospital pharmacists played a key role in clinical drug trial.They can get to know the basic research methodology from participating in the clinical drug trial,meanwhile their consciousness on scientific research can be strengthened.
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As of April 2005, “Shihango-rinsyoushiken” defined in the GPMSP was renamed “Seizouhanbaigo-rinsyoushiken” in the revised regulations (GPSP). The relevant part of the GCP was also modified at the same time. Strictly speaking, therefore, post-approval clinical trials are not the same as postmarketing clinical trials. This report provides an explanation of post-approval clinical trials and the related regulations. It is generally considered that post-approval clinical trials, which help gather more clinical information, should be actively pursued for the further development of approved drugs in the post-marketing setting. However, the results of the questionnaire show that pharmaceutical companies are not willing to conduct them, mainly due to the high cost. To improve the economic efficiency of post-approval clinical trials, it is necessary to streamline monitoring activities that account for 40% of the cost.
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Gastritis cystica profunda (GCP) is a rare disease in which cystically dilated gastric foveolae or glands extend into the muscularis mucosae or below. The pathogenesis of GCP has been described as an interruption of the muscularis mucosae and migration of epithelial elements to submucosa caused by presence of suture materials after surgery or erosion of the gastric mucosa in chronic gastritis and ischemia. Macroscopically, GCP may present not only as a giant gastric mucosal folds but also as a submucosal tumor or as solitary or diffuse polyps. An endoscopic ultrasonographic (EUS) findings clearly differ from findings in the other disordes. The combination of EUS and mucosectomy appears to be very useful for the diagnosis of GCP. Therefore, all unnecessary surgical procedures should be avoided in cases of GCP. We report a case of GCP associated with gastric perforation which presented as diffuse giant gastric folds and clinically advanced gastric cancer was suspected.
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Diagnosis , Endosonography , Gastric Mucosa , Gastritis , Ischemia , Mucous Membrane , Polyps , Rare Diseases , Stomach Neoplasms , SuturesABSTRACT
OBJECTIVE: This investigation was performed to uncover the nature of the clinical drug trials in the past in Korean psychiatry and to prepare some guidelines for the good clinical practice in the future. METHOD: We reviewed total 212 papers of the clinical drug trials in the major Korean psychiatric journals from April 1962 to December 1998. RESULTS: From the year 1985, when the pharmacological and biological organizations in psychiatry were found in our country, the clinical drug trials are rapidly expanding. Although open clinical trials in small sample size less than 30 subjects were the most frequent in the past, some well-designed clinical trials such as multicenter double-blind cross-over study were performed recently. Majority of these 212 clinical trials was done in patients with schizophrenia and mood disorders. Haloperidol was just the drug most frequently evaluated in the clinical trials in our country. As expected, among several clinical rating scales, Brief Psychiatric Rating Scale was the most frequently used. Prolactin and homovanillic acid were the materials frequently measured in the patients with schizophrenia. A few of these clinical trials were performed under the financial supports from the industry, and only one biological research had gained a fund from a national academic institute. To evaluate the researchers' concepts for the medical ethics in the clinical drug trials, we reviewed the description about the informed consent and the approval of institutional review board in all papers. Surprisingly, we found no descriptions about the informed consent in 113 papers(65.8%). Only one clinical trial was performed after the approval of the institutional review board. CONCLUSIONS: We confirmed that the majority of the clinical psychiatric drug trials in the past were performed in lacks of the concept of Good Clinical Practice(GCP). The KGCP guideline did not influenced on the researchers' concepts and performance for the medical ethics at all. Although all of the clinical trials may not need to be done under the guidelines of GCP, clinical researchers' efforts for the medical ethics should be continued for both, the patient and the researcher.
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Humans , Brief Psychiatric Rating Scale , Cross-Over Studies , Ethics Committees, Research , Ethics, Medical , Financial Management , Financial Support , Haloperidol , Homovanillic Acid , Informed Consent , Korea , Mood Disorders , Prolactin , Sample Size , Schizophrenia , Weights and MeasuresABSTRACT
Many computer systems can be used in the diagnosis and care of subjects in a clinical study,in dispensing drug supplies,and in performing laboratory tests required by the study protocol.It is important that these systems are closely controlled and perform reliably every time they are used.International regulations require that such systems be well documented.Audits and inspections at clinical study sites under Good Clinical Practice(GCP)will check such systems to be sure that they are reliable in performance and that their data is trustworthy.The Principal Investigator in a study is responsible for the quality of all computer systems used to meet the study protocol and for the quality and trustworthiness of all trial data collected either by paper or computer.
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The authors discuss the technical problems in clinical evaluation of newly-developed Chinese medicines.For improvement of evaluation quality,this paper puts forward some suggestions for solving the common problems such as unitary intervention pattern,lack of corresponding treatment for the changed syndrome,subjectivity in standards of syndrome-differentiated diagnosis,ill-chosen medicine in control group,and mismanagement of medicine combination.