| 1BackgroundBy reviewing relevant laws, regulations and guidelines issued by WHO, the United States and the European Union on safety monitoring of postmarketing drugs, and comparing those to domestic monitoring regulation status concerning postmarketing Traditional Chinese Medicine, we found that internationally, laws and regulations, technical specifications and guide system on postmarketing drug’s safety monitoring is relatively consummate and has been providing technical support to assist the carrying out of related work. However, due to the late start, an appropriate system of safety monitoring for postmarketing Chinese medicine, especially on Traditional Chinese medicine, hasn’t yet been developed. Traditional Chinese medicine is remarkably different from western drugs in its diversified component composite, complex clinical practice in TCM therapeutic regimen, uncertainty of effecting factors in clinical trial, and dynamic disease syndromes, which has all poetically hindered the setting up of its guidelines, and throws hospitals, enterprises and research institutions into a chaos while they have no basis to develop relative works. Therefore, the establishment of the guideline of Chinese traditional medicine safety monitoring is extremely urgent.At present, in the research of safety monitoring of postmarketing traditional Chinese medicine, a number of scientific research achievements has been formed. Scientific achievement is the crystallization of great efforts from scientific workers, and it’s also the valuable treasure of human civilization. Standardization is an important way to promote the international communication of Chinese medicine, and it’s significant in boosting China’s scientific and technological progress, improving market competitiveness and promoting international trade. Transformation of scientific research to the guideline is not only beneficial to improving the technology content of the standard, but also to the conversion from scientific research achievements into productivity. Therefore, only by absorbing the advanced scientific and technological achievements, reproducing the theory of traditional Chinese medicine and medical technology in standard form, can TCM keep pace with the times.This study, based on the guidance of technical documents such as National Standards Formulated Procedures and Standard of Traditional Chinese Medicine Management Approach (Trial), complies with the instruction of strengthening conversion from scientific research achievements into standards from standardization of traditional Chinese medicine and long-term development plan (2011-2020), systemically analyzed the scientific research achievements on intensive hospital safety monitoring of postmarketing TCM. By using transforming intensive hospital safety monitoring of postmarketing TCM scientific research achievements into guideline as an example, this study preliminarily explores for the method to transform scientific research achievements into guideline, in order to provide reference for the future technical specifications, thus to further the development of TCM.2ObjectivesUsing transformation from key technologies of intensive hospital safety monitoring on postmarketing Chinese Medicine into guideline as an example, preliminarily establish the path of transforming Traditional Chinese Medicine scientific research achievements into guideline.3The research contents and methods3.1The selection of scientific research achievements3.1.1To determine whether existing scientific research achievements has the potential to be transformed into guidelineCarrying out relevant scientific research is the prerequisite for the establishment of guideline. By searching related literature, regulations and policies, drawing lessons from " potential analysis method in the transformation of scientific and technological achievements into technology standard" issued in the "11th five year plan" key technical project "national plan for science and technology achievements into technical standards and development", undertook by Chinese Institute of Standardization, and combining with the characteristics of traditional Chinese medicine, preliminarily specified principles and items that can be used to determine whether the TCM research result can be transformed into technical standard.3.1.2Using the expert consensus method, determine the planAccording to the principle, this study finalizes transforming intensive hospital safety monitoring of postmarketing Chinese Medicine key technologies into guideline. According to the expert consensus conference results, determine the plan.3.1.3Put forward the guideline project proposalBased on the plan and according to the World Federation of Chinese Medicine Societies’ standard formulation and promulgation of standard, comes up with the guideline project proposals as following:â‘ â'–uideline name in Chinese and English;â‘¡The scope;â‘¢The proposal type;â‘£The existing related standard;⑤Necessity and Feasibility;â‘¥Outline of the project;⑦Basic information of sponsors;⑧Basic information of project Leader.Put forward the guideline project proposal into World Federation of Chinese Medicine Societies Technology and Standards Division. They fulfill the approval procedures, the Secretary General will discuss the guideline project proposal, approved the project after receiving formal approval.3.2To identify guideline making unitTo identify guideline making unit is important to transforming key technologies into guideline. The guideline making unit needs to have certain qualifications. It should be in the lead in the Traditional Chinese medicine filed, and shall have strong influence, so as to improve the promotion and application after research achievements have been transformed into regulation standards.Since the Specialty Committee of Evaluation of Postmarketing Chinese Medicines of World Federation of Chinese Medicine Societies has already became an industry leader, and this study applies to400medical institutions nationwide with a strong influence. Therefore, application and development of guideline will be responsible by the Specialty Committee of Evaluation of Postmarketing Chinese Medicines of World Federation of Chinese Medicine Societies.3.3The formation of guideline working group3.3.1Selection principle Select technical specification’s possible users in the widest range. Guideline working group composes of multidisciplinary personnel, senior experts, experts, first-line clinical physicians, pharmacists, scientific research personnel, methods-study researchers and so on, personnel distribute into old, middle age and young, three levels. The working group is responsible for drafting the active collection, analysis of relevant information, and absorbing the latest research results and previous standardization construction experience.3.3.2The composition of the working groupWorking group is suggested to be divided into the guidance committee and written work group, the guidance committee composed of senior industry experts, is responsible to put forward decision-making suggestions and general supervision guideline; written work group can be divided into literature retrieval group and the drafting group. Technical specification can be drafted by personnel with clinical, pharmaceutical, clinical epidemiological background; search and literature retrieval can be carried out by personnel with traditional Chinese medicine, clinical epidemiology knowledge background, and personnel with relatively good English proficiency.3.4Collecting writing materialsSupply relevant material on the basis of previous research, which includes: relevant laws and regulations concerning technical specification; laws and regulations concerning standardization; authoring tool, working guidelines for standardization, relevant rules and guidelines for standard drafting; extensively collect relevant literature and related standards of professional scientific research and technology, thus to save time for the preparation of guideline.3.5Draft guideline3.5.1Writing guideline in discussion versionOn the basis of the preliminary studies and plans discussed and finalized by experts, discussion version shall be drafted. In the process of drafting, shall extensively collect different views from the application parties, such as hospitals, enterprises and research units. 3.5.2Writing guideline in draft versionAccording to standardized management requirements, in order to make the guideline more recognized, guidance committee experts will be organized to check the guideline in discussion version, to further improve the draft. Written work group shall carefully consider and repeatedly discuss the views put forward by the guidance committee.After repeated discussions,"standard writing template TCS2009" in appendix6and using guides in the book of China academy of standardized Professor Bai Diyi’s book the writing of the standard published by the Chinese standard press will be adopted. Writing of technical specifications conform to the requirements of the standard of GB/T1.1regulation, draft of "Guideline for intensive hospital safety monitoring of postmarketing Chinese Medicine " will also be formed.3.5.3Guideline for commentsExternal views, which are from solicit units, educational and research institutions, enterprises, industry organizations and expert and other aspects, can be gathered via different forms such as English journals, web site for public comments. Meanwhile, there is also the need for internal validation. According to the technical specification, a questionnaire has been designed. In a questionnaire survey, issued a total of200questionnaires, and received181valid questionnaires. Mainly to evaluate scientifically the technology specification, summarizes the research and analysis of the feedback information, in order to supplement and perfect the guideline draft.3.5.4Draft guideline for examinationAfter a careful analysis of the comments one by one, summarize and settle advices, and then form manuscript of the guideline.3.6Investigation, approval, publishing, reviewSince investigation, approval, publishing and review of guideline are all responsible by the World Federation of Chinese Medicine Society, so only needs to proceed as its specific operation required.4ResultsThis study formed the Guideline for intensive hospital safety monitoring of postmarketing Chinese Medicine, and confirmed the path of transforming Traditional Chinese Medicine scientific research achievements into guideline.5ConclusionsThis study using the path of transforming intensive hospital safety monitoring of postmarketing Chinese Medicine key technologies into guideline as an example, preliminary explored the path of transforming Traditional Chinese Medicine scientific research achievements into guideline and provided reference for future studies. |
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