CDE Electronic Journal: complete clinical trial guidance document 2006-2016

Clinical trial refers to the biological scientific research conducted by human volunteers, also known as subjects Depending on the purpose of the trial, the subjects may be patients or healthy volunteers Drug clinical trials are used to study the effectiveness, safety and quality of drugs, in order to investigate whether they can be listed for clinical trials in specific populations On July 22 last year, CFDA released the announcement of "self inspection and verification of drug clinical trial data", which caused a huge wave in the industry 1622 varieties were verified, 1165 of which were voluntarily withdrawn by the enterprise, 40 of which were not approved or withdrawn, with a failure rate of 74.3% It's not hard to find that with the increase of national drug audit and supervision, the development of pharmaceutical enterprises is no longer so smooth The tightening of drug declaration and acceptance, the shortage of clinical resources, the high cost of clinical trials, and the unpredictable prospect Many pharmaceutical companies are struggling Under the influence of strict government, how to plan strategies and grasp the internal spirit of clinical trial research well needs pharmaceutical enterprises to deeply understand the relevant national laws and regulations, guidance documents and comprehensively and profoundly interpret them on the premise of deep internal skill The following is the clinical trial regulations and guidance documents of CDE electronic journal in the 10 years from 2006 to 2016, which are counted through the drug intelligence data policy and Regulations Database (http://db.yaozh.com/policies) The key words of "clinical trial" are input, all of which are clear at a glance, and are of great benefit to pharmaceutical enterprises in clinical trial operation The specific contents are as follows (click the title to view the full text): No regulation Title release date 1 Statistical consideration of missing data in clinical trials 2016.03.01 2 consideration of design and evaluation of clinical trials of 13 valent pneumococcal conjugate vaccine 2016.02.26 3 consideration of technical evaluation of clinical trials of seasonal influenza inactivated vaccine 2015.12.01 4 Some considerations for clinical trials of new Chinese medicine for treatment of liver fibrosis: 2015.07.01 5 expert consensus on the establishment of new antibacterial clinical trial break point; 2015.06.01 6 general considerations for clinical pharmacology research in clinical trials of innovative drugs: 2014.04.04 7 interpretation of technical guidelines for clinical trial data management (3): 2013.05.22 8 Some requirements on the clinical database and statistical results declaration data of EV71 vaccine after the completion of phase III clinical trial 2013.03.14 9 key points for the design of drug clinical trial for the treatment of bipolar disorder 2013.02.25 10 technical guidelines for the management of clinical trial data interpretation II 2013.02.21 11 general considerations in the design of drug clinical trial for the treatment of depression 2013.01.05 12 Consideration of clinical trial design and evaluation of drugs for chronic functional constipation interpretation of technical guidelines for clinical trial data management (1) key points of clinical trial design of ibuprofen injection on Dec 7, 2012 Interpretation of the key similarities and differences between China's current biostatistics guidelines for clinical trials and ICH e 9 on May 18, 2012 (3) review of phase III clinical trials of 19 nucleoside (acid) analogues in the treatment of chronic hepatitis B on August 29, 2011 General considerations for clinical trials of schizophrenic drugs 2011.07.01 21 key similarities and differences between China's current biostatistics guidelines for clinical trials and ICH e 9 (2) 2011.06.15 22 considerations for clinical trials of postmenopausal women's osteoporosis drugs 2011.06.08 23 China's current biostatistics guidelines for clinical trials and ICH Key similarities and differences of e 9 (1) issues to be concerned in the design of clinical trials of epoprolone on June 24, 2011 2011.04.12 28 Japan's basic regulatory concept for international multicenter clinical trials 2011.03.18 29 meeting minutes of special seminar on safety evaluation of clinical trials of new traditional Chinese medicine 2011.03.09 30 key issues to be focused on in clinical trials of new type 2 diabetes drugs cardiovascular risk evaluation 2010.11.23 31 consideration of key technical issues in clinical trials of new traditional Chinese medicine for cerebral infarction 2010.11.15 32 Relevant considerations for clinical trial requirements of skin topical drugs under the new regulations 2009.12.02 33 guidelines for virus safety evaluation of biotechnological drugs for clinical trial of EMEA 2009.10.22 34 consideration and understanding of clinical trial design of acute bacterial conjunctivitis 2009.03.30 35 m3 (R2) guidelines for clinical trial and non clinical safety research of supporting drugs on the market (III) 2008.10.21 36 m3 (R2) guiding principles for non clinical safety research of supporting drugs in clinical trials and on the market (II) 2008.10.21 37 m3 (R2) guiding principles for non clinical safety research of supporting drugs in clinical trials and on the market (I) 2008.10.21 38 discussion on the design of adaptive clinical trials 2008.07.11 40 current situation and Prospect of clinical trials of innovative antibiotics in China 2008.04.16 41 current situation and existing problems of research and development of new traditional Chinese medicine drugs in clinical trials of application for coronary heart disease and angina pectoris 2007.11.30 42 clinical safety evaluation and risk assessment of drugs before going on the market (IV) - management and evaluation of safety data in clinical trials 2007.11.30 43 Special consideration of clinical trial design of antimicrobial agents for skin and soft tissue infection on November 30, 200744 clinical safety evaluation and risk assessment of pre marketing drugs (V) -- Summary and evaluation of clinical trial safety data on November 30, 200745 clinical trial of traditional Chinese medicine eye drops 2007.11.26 47 consideration of the requirements for clinical application materials of international multicenter clinical trials 2007.11.23 48 consideration points of domestic clinical trials of pain drugs 2007.11.21 49 investigation and analysis of "bacterial culture positive rate" of clinical trials of antimicrobial drugs 2007.11.19 50 consideration of phase I clinical trials of domestic innovative drug healthy volunteers 2007.11.19 51 Thoughts on clinical trials of innovative antibiotics in China Phase II clinical trials of antineoplastic drugs -- introduction of conventional design and new strategies in the era of targeted therapy 58 introduction of basic specifications for clinical trials of cancer therapeutic vaccines and related biological products (2) general considerations for the formulation and clinical trials of fixed dose compound preparations of antituberculosis drugs (2007.04.09 59) introduction of 2007.03.20 60 EMEA guidelines for clinical trials in small population (Draft) introduction 2007.03.08 61 Introduction of FDA clinical research guideline collection of racial and ethnic data in clinical trials Trial design and observation index of clinical trials of drugs for the treatment of acute ischemic stroke 2007.02.11 64 introduction of the guiding principles of clinical trials of drugs for the treatment of HIV infection 2007.02.06 65 "basic norms for clinical trials of cancer therapeutic vaccines and related biological products" - Drafting background and main content 2007.02.05 66 Common scale in clinical trials of drugs for acute ischemic stroke 2007.02.01 67 Industry Guide - Estimation of the maximum safe initial dose of drugs in the first clinical trial of healthy adult volunteers Consideration of control selection in clinical trials 2006.12.13.71 attach importance to the basis of neutral issues in the process of new drug research and development, the relationship between test purpose and clinical trial design 2006.11.30 72 special considerations in the clinical trial design of photosensitive drugs 2006.11.30 73 some understandings of clinical trials of chemical oral sustained release preparations 2006.11.27.74 General considerations for clinical trial evaluation of prophylactic vaccine (1) general considerations for clinical scheme design and methodology 2006.11.2775 general considerations for clinical trial evaluation of prophylactic vaccine (3) - Safety Evaluation 2006.11.2776 general considerations for clinical trial evaluation of prophylactic vaccine (2) - effectiveness evaluation 2006.11.2777 general considerations for clinical trial of prevention of acute deep vein thrombosis 2006.11.2478 research progress of evaluation indexes of dementia clinical trial 2006.11.2479 use of placebo in Alzheimer's clinical trial Key points for diagnosis of acute ischemic stroke and criteria for selection of subjects in clinical trials Discussion on the design and progress of clinical trials of innovative drugs Some reviews in clinical trials of anti infective drugs some experiences in the clinical trials of 2006.05.3091 in vivo auxiliary diagnostic reagent for tuberculosis General consideration of "confirmatory clinical trial" of innovative compound antihypertensive drugs 2006.03.3195 EMEA's consideration of bacterial resistance in clinical trials of antibacterial drugs 2006.02.23 96 General requirements for clinical trials of sedative hypnotics 2006.02.15 97 requirements for clinical trials of sedative hypnotics sleep laboratory 2006.02.14