| CROs first emerged in the US in the 1970s and developed rapidly in the US,Europe,and Japan in the late 1980s.In the 1990s,a boom in CRO industry development entered China,which also drove the R&D enthusiasm of the Chinese pharmaceutical industry.During the golden decade of CRO development from 2004 to 2014,CROs participated in the R&D of chemical drugs and generic drug projects of most local pharmaceutical companies,and their market scale and growth rate grew significantly,making them a "dark horse" in the segment of financial investment in pharmaceuticals.During this period,several local CROs have also grown rapidly and become leading companies in pharmaceutical R&D outsourcing services by their excellent talents and project experience.The research and development of Chinese medicine and natural drugs have long been one of the important directions of new drug development in China.However,due to historical reasons,the development of Chinese medicine in China has not yet fully realized the model of equal emphasis on the development of Chinese and Western medicine,coupled with the special characteristics of Chinese medicine itself,which makes the development of new drugs in Chinese medicine even more difficult.Therefore,how to leverage the R&D power of CRO to help the TCM industry achieve rapid growth will be an important approach to the future development of TCM.Objective:Taking the CRO perspective as the entry point and the participants of the Chinese medicine R&D outsourcing service industry chain as the target,we conduct a survey and research on the R&D situation and needs of Chinese medicine in the pharmaceutical industry.On this basis,we analyze in-depth the current situation of the Chinese medicine R&D service outsourcing industry and the causes and problems of its lack of development and explore the differences in service needs between CROs conducting Chinese medicine R&D projects and general CRO R&D projects.It also proposes thoughts and countermeasures for CROs to improve the level of TCM R&D services and enhance the competitiveness of TCM R&D.Methods:(1)This study adopted the literature research method.The policies,laws,and regulations of the relevant state departments supporting the development of TCM R&D in recent years were collected and collated,and the hindering factors affecting the clinical development of TCM at the current stage were summarized and analyzed to provide a theoretical reference basis for the subsequent questionnaire research content design.(2)PEST and SWOT analysis.Through PEST and SWOT analysis of the collected literature,industry reports,statistical yearbooks,legal policies,etc.,not only can the reasons and problems that restrict CROs from operating clinical research projects in Chinese medicine at the present stage be obtained from macro and micro perspectives respectively,but also the corresponding four types of strategies can be used to provide suggestions for CROs to operate Chinese medicine R&D services.(3)Questionnaire survey method.Based on the results of literature research,PEST and SWOT analysis,pharmaceutical companies and CROs are used as research objects,and research is carried out around their company scale,business types and their share,the general situation of R&D drug registration classification,and its adaptability,R&D willingness,the prediction of future business share,the advantages and disadvantages factors of TCM R&D,etc.The questionnaires for pharmaceutical companies and CROs were mainly distributed,collected,and collated through the online questionnaire Star Research.(4)Data analysis method.The research data were collated and entered into SPSS 20.0 software to standardize the research data;subsequently,descriptive analysis and chi-square test were conducted on the data.(5)Case study analysis.In this study,Beijing Duhengzhidao Pharmaceutical Technology Co.,Ltd.and Beijing Qihuang Pharmaceutical Clinical Research Center,which are CRO companies mainly engaged in clinical research of Chinese medicine,are selected as the case study subjects.To a certain extent,the actual research objects can reflect the characteristics and development rules of the industry as a whole,which helps the researcher to summarize and conclude the problems and phenomena encountered in the development of CRO industry and understand the operation mode of CRO and its successful experience.Results:(1)PEST and SWOT analysis methods were used to analyze the collected literature,policies,laws and regulations,statistical yearbooks,and other information.In summary,it was concluded that,under a macro perspective,legal policies have the greatest impact on TCM R&D and determine the quality and direction of TCM R&D,which is mainly reflected in the changes to the requirements and systems for TCM evaluation.Therefore,the formulation of policies,laws and regulations,specific operational standards,etc.that meet the characteristics of TCM development and thus shape a general environment suitable for TCM R&D is the challenge at the national level at this stage.From a micro perspective,finding specific implementation methods for clinical research in line with TCM is the main issue that needs to be addressed by TCM companies,institutions,and CROs in the pharmaceutical industry at this stage.(2)A total of 112 responses were collected from pharmaceutical practitioners,of which 66 were from pharmaceutical companies,who are usually the initiators(sponsors)of R&D outsourcing projects,and 46 were from CRO companies,who are usually the implementers of R&D outsourcing projects.The analysis of the results from both sides shows that the proportion of TCM projects undertaken by CROs is relatively low,accounting for about 35%of the total number of projects undertaken by CROs,and the scale of enterprises/companies operating TCM projects is still mostly small and medium-sized,which makes the industry relatively less risk-resistant.For the whole pharmaceutical industry,the advantages of "good efficacy" and "wide audience" and the disadvantages of "difficult to define the toxic side effects" and "lack of gold standard" are the same.These factors do not vary significantly depending on the role of the company or company in the industry.Moreover,clinical research in TCM is not simple to conduct in practice,nor is it cheap to operate,and even the profit margin can be relatively low,which is part of the reason why clinical research projects in TCM have a lower market share in CROs compared to chemical and biological drugs.Besides,compared to pharmaceutical companies,which are more susceptible to the macro environment,CROs are more susceptible to the micro(their capabilities)environment,such as industry visibility.Therefore,CROs also need to strengthen their "corporate communications" and "corporate image".(3)Chinese medicine projects are different from the projects that CROs are generally responsible for and require a three-pronged evaluation system that combines Chinese medicine theory,human experience,and clinical trials.Among these three aspects,the practitioners in CROs are generally only relatively experienced in "clinical trials",but lack an in-depth understanding of "TCM theory" and "human use experience".They also lack a deep understanding of "TCM theory" and "human experience".The learning of "TCM theory" can be done through staff training and lectures by experts.The "human use experience" needs to be explored and familiarised with by practitioners in the course of their projects.Therefore,CROs need to pay special attention to the collection and collation of evidence and data related to the new concept of "human use experience",and gradually shift their focus to clinical practice before clinical trials are conducted,so that the development of Chinese medicine does not only stop at the validation stage of clinical trials but also the exploration of innovative points in clinical treatment.Also,CROs need to prepare a good reserve of personnel and technology from a TCM background to pave the way for subsequent TCM clinical trials.(4)As drug development projects become more complex,most CROs will no longer be able to make a profit by providing scientific research and technical services singly,and CROs will need to look at the whole industry chain of pharmaceutical R&D and provide new business models to increase their market value.For example,by becoming an investment CRO,focusing on drug development while investing in Chinese medicine projects with some potential clinical value to help them expand their sales market.Conclusion:Through the collation and analysis of the collected and collated four categories of macro influences on the policy and legal environment,economic environment,social environment,and technological environment related to Chinese medicine R&D,as well as the four micro influences of advantages,disadvantages,opportunities,and risks,combined with the results of the actual research on Chinese medicine projects in the CRO industry,the macro,and micro issues in the Chinese medicine industry,have been summarized and inducted,which provide reference suggestions and development advice for the Chinese medicine R&D services to be taken over by CRO companies that are about to take over R&D services in TCM are provided with reference suggestions and development directions. |
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