GCP Conference - Highlights

Source: China pharmaceutical innovation promotion association June 22, 2017 June 10 and 11, 2017, the second China clinical research quality management (GCP) and innovative drug research and Development Conference "was held in Yantai, Shandong Province A number of domestic clinical experts were invited to attend the meeting and made wonderful and vivid academic reports At the meeting, experts at the meeting shared their clinical management experience and unique insights in their respective research fields, which not only provided academic exchange opportunities for participants, but also provided them with a rich and unforgettable feast The China Pharmaceutical Innovation Promotion Association (hereinafter referred to as "the pharmaceutical promotion association") has sorted out and selected the unique opinions of some clinical research experts for you Wang Yongjun: in the report, Wang Yongjun, executive vice president of Beijing Tiantan Hospital Affiliated to Capital Medical University, introduced in detail his experience in initiating, designing, organizing, managing and implementing the trial of "Socrates" international multi center clinical research, which he participated in and completed Antiplatelet therapy has always been the basic drug for acute stage and secondary prevention of cerebrovascular disease However, due to the evidence, only aspirin has been recommended in the guidelines for acute cerebrovascular disease for many years Whether newer and more effective antiplatelet drugs can be used has always been the field that cerebrovascular experts are committed to exploring In order to compare the effect of tegrilol, a fast acting antiplatelet drug P2Y12, and aspirin on the prevention of ischemic recurrence, the international expert group of Socratic research conducted a clinical exploratory study design for this trial In this study, acute ischemic stroke or high-risk TIA population were selected as subjects, and the main outcome was first stroke, myocardial infarction or death Socrates study is a registered study in 21 countries and regions around the world There are 13199 patients in the world, and more than 1100 patients come from mainland China As a clinical study of optimal design, although the primary and secondary endpoints of tegrilol group and aspirin group did not reach the significant statistical difference, and the Socrates study did not reach the design endpoint, the analysis of tegrilol in Asian subgroup still has a trend of reducing the primary endpoint events, which suggests that we may need to find a more appropriate one The dosage and the population can bring more benefits to the patients in addition The rigorous clinical trial organization and management structure established by Socratic research, which is composed of Academic Committee, executive committee, data management committee, clinical event arbitration committee and national research director, and the clear provisions for researchers to perform their duties in international multicenter clinical trials, provide important information for Chinese clinical institutions to independently lead international multicenter clinical studies Experience At the same time, vice president Wang Yongjun also summed up the main problems faced by China's current clinical trials: first, international drugs are all global registration trials synchronized, and almost no Chinese applicants start multi-national synchronous clinical trials, nor have international medical departments been established Second, the level of domestic clinical trial institutions (GCP bases) is uneven, the clinical trial design is still the biggest short board, and the project management process needs to be improved He called on the government to consider the international orientation of the policy when formulating the clinical trial management policy, and to formulate the international standards and review process with an international perspective, so as to promote the internationalization process of clinical trials in China Wang Yongjun, executive vice president of Beijing Tiantan Hospital Affiliated to Capital Medical University, Shi Yuankai: the development trend of clinical research on antitumor drugs According to vice president Shi Yuankai, the efficacy, quality, dosage and safety of drugs are the main concerns of clinical research In the past, the clinical research of anti-tumor drugs mainly focused on molecular targeted drugs, but at present, the research and development of anti-tumor drugs is on the rise As of January 2017, 15 recombinant anti-CD20 mouse chimeric monoclonal antibodies had applied for clinical trials and 12 were approved for clinical trials; 18 EGFR monoclonal antibodies (including all human, humanization and chimerism) had applied for clinical trials and 14 were approved for clinical trials; 27 VEGF monoclonal antibodies had applied for clinical trials and 16 were approved for clinical trials Vice president Shi Yuankai believes that it is urgent to improve the capabilities of enterprises, researchers, ethics committees, supervisors, reviewers, verifiers and other parties, and cultivate and establish a good ecological environment for clinical drug research and evaluation Researchers should strengthen communication with drug regulatory authorities and pay attention to the dynamic supervision of the whole process of drug clinical research and development, which is an effective means to ensure the safety of subjects, scientific research and development of drugs, and promote the listing of new drugs with clinical needs Shi Yuankai, vice president of cancer hospital, Chinese Academy of Medical Sciences, huoyong: Vice President of China Cardiovascular Health Alliance and director of Department of Cardiology and heart center of Peking University First Hospital, huoyong, shared in his report how to design the clinical research scheme Director Huo Yong pointed out that the basic design of intervention research includes ① hypothesis: research purpose; ② intervention means: drugs; ③ intervention population and sample size: the difference between experiment and control; ④ main end point and observation time: number of end point events Taking enalapril Folic Acid Tablets, atorvastatin, bivalirudin and rosuvastatin as examples, this paper introduces how to design clinical trials for different experimental purposes Director Huo Yong led the team to carry out the China stroke primary prevention study (csppt), which is the largest sample size primary prevention study carried out by Chinese researchers in accordance with the international randomized, double-blind control standards, aiming to explore the impact of enalapril folate tablets (referred to as yiblade) on the initial stroke in the population with high blood pressure In this study, 20702 adult hypertension patients without history of stroke and myocardial infarction were intervened and followed up for 4 and a half years, which provided solid evidence for the prevention and control of stroke with Chinese characteristics, and also provided a design blueprint for large sample size evidence-based medicine research in China Director Huo Yong believes that we should face up to the fact that the mortality rate of coronary heart disease and stroke in China is higher than that in European and American countries Clinical research as the most important stage of drug research and development, research short board greatly restricts the process of drug research and development in China From prevention to treatment, large-scale clinical research is also needed, so clinical research faces great challenges As a clinician, we should forge ahead, so as to help enterprises and institutions develop better drugs Huo Yong and Cui Yimin, director of Cardiology and Cardiology Center, Peking University First Hospital: major changes in the era of "backup case" and Countermeasures for clinical institutions and enterprises Cui Yimin, President of China antithrombotic drug treatment alliance and director of clinical trial center of Peking University First Hospital, put forward his own ideas on how to implement the filing system of clinical trial institutions and how to adapt to the reform of clinical institutions and enterprises In his opinion, when clinical trial institutions are transitioning to clinical trial centers, they should pay equal attention to service and management, instead of focusing on management instead of service In terms of service, we should build a high-quality clinical trial support platform to provide comprehensive services for clinical researchers In management, we should promote the standardization of clinical trials Only in this way can we cultivate an international, professional and professional clinical evaluation team for the research and development of innovative drugs in China At the same time, director Cui Yimin also provides several suggestions for the enterprise First of all, the enterprise should really take the responsibility for the drugs developed, have the ability to select high-quality clinical trial centers, and improve the ability of trial scheme design or scheme evaluation In addition, the enterprise shall participate in the preparation of the first draft of the clinical trial scheme, actively communicate with the review agency, and modify and determine the clinical trial scheme according to the drug characteristics and review requirements before carrying out the clinical trial Finally, in the process of clinical trials, enterprises should strengthen supervision and inspection, find out problems in time, and improve the authenticity of clinical trials and the integrity of data Cui Yimin, director of clinical trial center of Peking University First Hospital, explores the application and importance of information technology in future clinical trials Liu Zeyuan, deputy director of GCP organization and director of General Office of Affiliated Hospital of Academy of Military Medical Sciences, proposed that phase I clinical trial management should attach great importance to the following four aspects: ① the whole process management of volunteers can be reviewed; ② the whole process management of experimental drugs; ③ sample collection, separation, use of barcode, strict control of time points; ④ the quality control status of documents / data, always in review and Audit status Director Liu introduced the database of clinical research volunteers that they created to the participants The database has the advantages of improving test efficiency and saving test screening costs, and has been promoted and used in many hospitals It is reported that the database is the only database supported by major new drug creation at present, to ensure the authenticity of clinical trial data According to Director Liu, the future clinical trial information system should have the basic characteristics of individuation, integration, process, scalability (cloud service), ECRF automatic generation and complete validation scheme The clinical trial party, the sponsor and the researcher shall establish a mutual evaluation system: the main person in charge of the clinical trial shall be responsible for the project approval and start-up; the sponsor is the first person responsible for the clinical quality; the researcher shall focus on the quality of the trial and make the clinical trial well Liu Zeyuan, deputy director of GCP organization and office director of Affiliated Hospital of Academy of Military Medical Sciences