An Interview with Lisa McDonald, Metagenics Senior Director of Marketing and Medical Education.

No Abstract Available.

[Analysis of Key Points of Technical Review of Traditional Chinese Medicine Fumigation Treatment Device].

Traditional Chinese medicine fumigation device is the carrier of traditional Chinese medicine fumigation treatment. In recent years, with the rapid development of new technology and new materials, the development of fumigation device changes with each passing day, and a variety of new products continue to emerge. However, at present, the lack of corresponding evaluation norms, resulting in some difficulties in the registration, marketing, quality control, evaluation scale and other aspects of the product. Some products have many disadvantages in clinical use. From the perspective of technical review, this paper elaborates and analyzes the main concerns in technical review, such as product structure, main risks, performance requirements, clinical evaluation, etc., in order to provide a basis for the design, development, production, registration, use and post-marketing supervision of the devices.

The effects of colostrum consumption and feed restriction during marketing and transportation of male dairy beef calves: Impact on pre-transport nutritional status and on farm recovery.

The aim of this study was to evaluate the effects of colostrum consumption and feed restriction on biomarkers of stress, nutritional and health status, gut functionality, and behavior in male dairy beef calves being marketed and transported. A total of 82 male Holstein calves (42 ± 1.2 kg of body weight and 14 ± 0.9 d of age) were used to study the amount of colostrum given at birth at the dairy farm of origin, the degree of feed restriction suffered at an assembly center simulation (d -4 to d -1), and the effects of a 19 h transportation (d -1). Treatments were as follows: control calves (CTRL; n = 16) were fed 10 L of colostrum at the dairy farm of origin, milk replacer (MR) and concentrate at the assembly center, and were not transported; calves fed high colostrum and milk replacer (HCMR; n = 17) were given 10 L of colostrum at the dairy farm of origin, MR at the assembly center, and transported; calved fed high colostrum and rehydrating solution (HCRS; n = 16) were given 10 L of colostrum at the dairy farm of origin, a rehydrating solution (RS) at the assembly center, and transported; calves fed low colostrum and milk replacer (LCMR; n = 17) were given 2 L of colostrum at the dairy farm of origin, MR at the assembly center, and transported; and calves fed low colostrum and rehydrating solution (LCRS; n = 16) were given 2 L of colostrum at the dairy farm of origin, RS at the assembly center, and transported. Transported calves mimic a 19-h transportation. After transport, all calves were fed 2.5 L of MR twice daily and had ad libitum access to concentrate, straw, and water. Calves' recovery was followed for 7 d. Concentrate intake and health records were collected daily from d -4 until d 7 and body weight (BW) and blood samples were collected on d -4, -1, 0, 1, 2, and 7 of the study. Results showed that the feeding regimen provided at the assembly center reduced BW for the HCRS and LCRS calves compared with the CTRL, HCMR, and LCMR calves. Concentrate intake peaked on d 0 in the transported calves, followed by a reduction of intake on d 1 after transportation. Concentrate intake recovery was lower for the LCRS and LCMR calves. On d -1, nonesterified fatty acids and ß-hydroxybutyrate concentrations were greater for the HCRS and LCRS calves compared with the CTRL, HCMR, and HCRS calves. After transportation, serum Cr-EDTA concentration was greater for the HCRS and LCRS calves than the HCMR, LCMR, and CTRL calves. The LCRS calves had the lowest serum concentration of citrulline. Finally, health scores were greater for the LCRS calves from d 0 to 7. In summary, both the greatest degree of feed restriction during the assembly center and the low colostrum consumption at birth negatively affected the recovery of concentrate consumption and BW, gut functionality, health status, and behavior in calves after arrival at the rearing farm.

Nutrition-Related Information on Instagram: A Content Analysis of Posts by Popular Australian Accounts.

Social media is a popular source of nutrition information and can influence food choice. Instagram is widely used in Australia, and nutrition is frequently discussed on Instagram. However, little is known about the content of nutrition information published on Instagram. The aim of this study was to examine the content of nutrition-related posts from popular Australian Instagram accounts. Australian Instagram accounts with ≥100,000 followers, that primarily posted about nutrition, were identified. All posts from included accounts, from September 2020 to September 2021, were extracted and posts about nutrition were included. Post captions were analysed using Leximancer, a content analysis software, to identify concepts and themes. Text from each theme was read to develop a description and select illustrative quotes. The final sample included 10,964 posts from 61 accounts. Five themes were identified: (1) recipes; (2) food and nutrition practices; (3) body goals; (4) food literacy and (5) cooking at home. Recipes and practical information about nutrition and food preparation are popular on Instagram. Content about weight loss and physique-related goals is also popular and nutrition-related Instagram posts frequently include marketing of supplements, food and online programs. The popularity of nutrition-related content indicates that Instagram may be a useful health-promotion setting.

RATIONAL PHARMACOTHERAPY ON THE BASIS OF PHARMACOECONOMIC JUSTIFICATION AND MARKETING RESEARCH ON THE APPLICATION OF IMMUNOMODULATORY PHYTOPREPARATIONS.

OBJECTIVE: The aim: Pharmacoeconomic substantiation and marketing research of immunoprotective phytopreparations in Ukraine to substantiate rational pharmacotherapy of the effectiveness of immunomodulatory drugs of plant origin and pharmaceutical care of patients to strengthen individual immunity. PATIENTS AND METHODS: Materials and methods: Research materials - data from the State Register of Medicinal Products of Ukraine; information content of the Public Health Center of the Ministry of Health of Ukraine; data of the State Register of Wholesale Prices for medicines declared in Ukraine under the international non-proprietary or common name as of 01.01.2023. Research methods: theoretical analysis of scientific sources, systematic, retrospective, descriptive and frequency analysis of information resources of databases; pharmacoeconomic analysis, marketing analysis of positioning in the pharmaceutical market of Ukraine to substantiate rational pharmacotherapy and the effectiveness of immunomodulatory drugs of plant origin to strengthen individual immunity. RESULTS: Results: Theoretical analysis and pharmacoeconomic substantiation of rational pharmacotherapy of efficiency of application of drugs of immunomodulatory action of plant origin and pharmaceutical care for strengthening of individual immunity of patients is carried out. The algorithm of pharmacoeconomic analysis of the use of immunomodulatory phytopreparations to ensure rational pharmacotherapy and pharmaceutical care of outpatients is substantiated. To substantiate the availability of effective immunomodulatory phytopreparations for patients, marketing research on the use of immunomodulatory phytopreparations in Ukraine has been conducted. CONCLUSION: Conclusions: The theoretical analysis shows that the use of immunomodulatory drugs of plant origin is appropriate in rational pharmacotherapy to strengthen the individual immunity of patients, which is especially relevant in an exacerbation of the epidemic situation caused by the spread of infectious diseases of viral origin. An algorithm of pharmacoeconomic substantiation has been developed, which provides an opportunity to confirm the therapeutic efficacy and pharmacoeconomic feasibility of immunomodulatory phytopreparations for rational pharmacotherapy and pharmaceutical care of patients. The results of marketing research provide an opportunity to determine the availability (positioning and price range) for patients of effective immunomodulatory phytopreparations in Ukraine and outline the prospects for pharmaceutical development and registration on the pharmaceutical market of Ukraine of new effective immunomodulatory drugs of plant origin.

Reasons for supply side driven drug shortages - A mixed-methods study on first-level, higher-level, and root causes from the perspective of marketing authorization holders.

BACKGROUND: Drug shortages impact multiple stakeholders and are detrimental to patient safety. Additionally, drug shortages are an extensive financial burden. In Germany, drug shortages, according to data from the federal ministry for drug and medical products (BfArM), have been increasing by 18% between 2018 and 2021. Studies show that shortages are most frequently supply side driven and that often reasons remain unknown. OBJECTIVE: The aim is to develop a holistic understanding of supply side causes for drug shortages in Germany from marketing authorization holders' perspectives and to derive implications for shortage mitigation. METHODS: A mixed-methods research design, with a grounded theory approach based on a structured literature review, BfArM data analysis, and semi-structured interviews, was used. RESULTS: Input factor supply issues, manufacturing issues, logistics issues, product recalls, and product discontinuations were identified as first-level causes. Furthermore, a theory on their connection to higher-level causes related to business decision-making, as well as root causes linked to regulations, company values, internal processes, market dynamics, external shocks, and macroeconomic factors, was developed. CONCLUSION: Actions to mitigate drug shortages in Germany (e.g., improving business processes, diversifying tender criteria) were derived. These may thus increase patient safety and decrease the financial burden on the healthcare system.

Marketing Archive Management of Drama Intangible Cultural Heritage Based on Particle Swarm Algorithm.

Each Chinese region has its own ancient opera, which is a treasure of folk culture and a living fossil for studying the historical origins of a local culture. It has significant academic value and historical significance at the national and local levels, whether from the perspective of promoting and disseminating national culture or from the perspective of protecting the world's intangible cultural heritage. Based on this practical significance, this paper conducts a study using the particle swarm algorithm to manage the marketing archives of drama intangible cultural heritage. The article employs the PSO algorithm to test the particle swarm optimization algorithm's convergence and conditions. The effectiveness of the algorithm is analysed in the Sphere function, Rosenbrock function, Griewanks function, and Rastrigin noncont function, and then the algorithm is compared, including the calculation speed comparison between the algorithm in this paper and the three optimal fitness functions. The experimental results show that the PSO algorithm has the highest four items in the statistics of the Schwefel function experimental results. About 45.0379 is the best value and 70.5878 is the maximum precision. The optimal average value is 6.1524, while the average value is 56.15245. In comparison to the QPSO and PSO algorithms, the algorithm in this paper has a faster convergence speed and better search accuracy. The topic of the intersection of the disciplines of drama, intangible cultural heritage marketing, and archive management using the particle swarm algorithm is well-developed.

Quality by design (QbD) approach in marketing authorization procedures of Non-Biological Complex Drugs: A critical evaluation.

The emergence of innovator-driven complex drug products, such as Non-Biological Complex Drugs (NBCDs), has provided disruptive advances in the Nanotechnology and Biotechnology fields. However, the design and development of NBCDs can be particularly challenging due to some unresolved scientific and regulatory challenges associated with the pharmaceutical quality assessment. The application of a more holistic, systematic, integrated science and risk-based approach, such as Quality by Design (QbD), is essential to address key scientific, technological, and regulatory constraints in the research and development of the NBCDs. The deeper product and process understanding derived from the implementation of the QbD approach ensures consistent, reliable, and high-quality pharmaceutical products. Furthermore, this approach promotes innovation and continuous improvement in the entire product lifecycle. Regulatory authorities highly recommend QbD-based submissions to successfully translate NBCDs from laboratory-scale research to the pharmaceutical market with the required quality, safety, and efficacy standards. The main aim of this article is to obtain a comprehensive and in-depth investigation into the state of implementation of the QbD approach in the pharmaceutical development and marketing authorization of NBCDs in Europe and the United States, through the analysis of the available data from their regulatory dossiers. In addition, it aims to understand and discuss how the QbD approach is used and implemented for complex drug products in the pharmaceutical industry, highlighting the gaps and challenges involved with its implementation. An analysis is held regarding QbD's advantages in terms of knowledge growth, regulatory flexibility, and the speed of development based on big data science, along with the reduction of regulatory failures and market withdrawals.

Determining the COVID-19 effects on spillover between oil market and stock exchange: a global perspective analysis.

This paper investigates volatility spillovers between the global crude oil market and the stock markets of the global oil stock markets (Russian, Canada, China, Kuwait, and the USA) pre and after the COVID-19 pandemic. We use wavelet Granger causality methods to study the volatility spillovers between global oil stock markets, mainly from January 1, 2019, to March 31, 2021. Our Results (1) shows that WTI and Brent oil prices had a negative mean return before COVID-19 but a positive mean return during the pandemic spread. Other Results (2) find the positive, significantly lowest, and highest frequency during the COVID-19 outbreak for all selected countries. The results also show that the link between oil WTI & Brent prices and stock markets return in the lowest (33-66 days) and highest frequency range (4-16) before the Covid-19 epidemic, especially in the first quarter of 2020. Before the COVID-19 period, the Russian oil stock market is seriously prejudiced with oil prices on a modest scale, but not after the pandemic's start. This study also perceives direction opposite between the COVID-19 period. The Canadian and United States America oil and stock markets influence the lowest scale in the previous COVID-19 sample for the U.S. market. Moreover, this paper exposed that oil marketing highest oil futures in their portfolios than stock shares for all times. We found that oil price shocks had a more significant impact on the stock markets of the United States and Canada than on the stock markets of other countries.

Which Features of Dietary Supplement Industry, Product Trends, and Regulation Deserve Physicians' Attention?

Patients expect that dietary supplements they purchase-and physicians expect that dietary supplements they recommend-are safe, accurately labeled, quality products. Since many dietary supplements, especially vitamins and minerals, are key parts of evidence-based interventions for patients with many conditions, illegal, fraudulent, adulterated, or improperly labeled products should be regarded as sources of clinical and ethical concern. Adverse events (AEs) can occur and, when they do, relevant data should be carefully collected and analyzed. This article considers how many physicians' and patients' confusion about dietary supplement regulation can undermine quality caregiving and responses to AEs. This article also summarizes a recent American Medical Association Council on Science and Public Health report on dietary supplement supply and marketing practices and on physicians' roles in guiding patients when dietary supplement use is clinically indicated.

Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval.

BACKGROUND: Research and development of pediatric drug faces many difficulties and pediatric clinical trials remain a challenge. Since 2011, a series of measures have been taken to encourage research, development of drugs for pediatric patients in China. In this study, we analyzed pediatric clinical trials conducted in China to provide reference for research and development of pediatric drugs and formulation of relevant policies. METHODS: We conducted a cross-sectional observational study of pediatric trials registered in the Drug Trial Registration and Information Publication Platform before Oct. 31, 2021. All trials that recruited children (under 18 years old as defined in China) were retrieved and general characteristics of the trials and the research drugs were extracted and analyzed. The data were extracted and statistically analyzed by excel 2010 and SPSS 22.0, respectively. RESULTS: There were 588 registered pediatric clinical trials, which accounted for 3.94% of the total registered trials. The overall average annual growth rate of the number of trials from 2013 to 2020 was 14.47% (P < 0.01). Of the 588 trials included, there were 312 trials (53.06%) with only children as subjects, 127 trials (21.60%) with research drugs only for children use, and the median of target subject number was 320 with the range of 8 to 600,000. The sponsors and the principal investigators were mainly located in the eastern and northern China. 325 trials were vaccine trials, and the dosage form was mainly injection. There were 98 non-vaccine biological product trials (mainly injections), 135 chemical compound drug trials (mainly tablets), 30 traditional Chinese medicine/natural drugs (mainly granules). Indications of the non-vaccine drugs were mainly diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism. CONCLUSION: The number of pediatric clinical trials in China has increased these years. To further promote pediatric clinical trials and motivate pediatric appropriate drug marketing application and administrative approval, conducting large pediatric clinical trials, further development of dosage forms suitable for children with special attention to neonates and prematurity, and improving uneven geographical distribution of sponsors and researchers are the current challenges.

Choice, Motives, and Mixed Messages: A Qualitative Photo-Based Inquiry of Parents' Perceptions of Food and Beverage Marketing to Children in Sport and Recreation Facilities.

Unhealthy food and beverage availability and sponsorship undermine healthy food practices in sport and recreation. We conducted a focused ethnography with reflexive photo-interviewing to examine parents' awareness, reactions, and experiences of food and beverage marketing in and around their children's physical activity in public sport and recreation facilities. Eleven parents took photos of what they thought their facility was 'saying about food and eating'. Photos guided semi-structured interviews on the '4Ps' of marketing (product, pricing, placement, promotion). Thematic analysis was conducted by holistic coding followed by in vivo, versus, and value coding. Photo-taking increased parents' awareness of food marketing in facilities. Reactions to food and beverage marketing were positive or negative depending on parents' perspectives of healthy food availability (choice), marketers' motives, and mixed messages within the facility. Parents experienced their children requesting 'junk' food at the facility leading to parents actively attempting to reduce the frequency of these requests. Healthy eating promotion in sport and recreation facilities was misaligned with the foods and beverages available which contributed to parents' distrust of social marketing initiatives. Critically evaluating the alignment of commercial and social marketing in recreation and sport may help inform effective healthy eating interventions that are accepted and supported by parents.

Moving from silos to synergies: strengthening governance of food marketing policy in Thailand.

BACKGROUND: Governance processes play an important role in shaping the formulation and implementation of policy measures such as restrictions on marketing of ultra-processed foods. However, there is limited analysis of the factors that affect governance for nutrition, especially in low- and middle-income countries such as Thailand and the Southeast Asia region. This study aimed to examine governance factors that create opportunities and challenges for the introduction of policy to restrict food marketing in Thailand, in line with the WHO recommendations to restrict food marketing to children. METHODS: A qualitative study design was used. Interviews were conducted with 20 actors with experience and in depth knowledge of food marketing in Thailand, including government, civil society, industry and international organisations. Open questions were asked about experiences and perceptions of the governance processes related to policies for restricting food marketing in Thailand. Themes were derived from the 3-i Framework which relates to interests, ideas and institutions influencing the introduction of food marketing policy were identified and analysed using abductive methods. RESULTS: Actors viewed institutional challenges as a significant barrier to advancing effective regulation of food marketing. Three major clusters emerged from the data: interests (priorities, relationships), institutions (formal structures, informal structures, broader institutional strategies), and ideas (norms). The study has three major findings in relation to these factors, highlighting the influence of formal structures, institutional interests in food marketing issues, and ideas in promoting multisectoralism. The siloed nature of policymaking was reflected in the government failing to stimulate engagement among key actors, posing challenges for implementation of effective policy change. Contested interests led to disagreements between actors over food marketing agenda and thus competing policy priorities. Consistent with these findings, the lack of effective mechanisms to promote multisectoral coordination across diverse actors reinforced barriers to policy change. CONCLUSION: The findings highlight ongoing challenges to the government's aim to strengthen policy to restrict food marketing which, without greater coordination in governance mechanisms, will hinder effective regulation and the achievement of public health goals. This analysis suggests that the Government should prioritise the development of a holistic, multisectoral approach to improve governance for better nutrition outcomes by overcoming policy silos.

Around the same table: Uniting stakeholders of food-related communication.

There is an abundance of messages on food and health communicated nowadays by diverse stakeholders, including nutrition and health experts, food industries, celebrity chefs, and food influencers, among others. If each of these stakeholders has different interests and uses other communication strategies, confusion and polarization about food and nutrition is likely to arise. Especially when these messages not only represent facts, but many are emotionally loaded, focusing on "beliefs". Yet even when stakeholders contradict each other in their communication about food related to health, they influence each other. This conceptual paper aims to identify and position the different stakeholders participating in discourse about food and health. Taking a stakeholder marketing perspective in which understanding the whole requires a holistic view, we position the stakeholders as interrelated networks and discuss how their communication strategies influence each other. Stakeholder multiplicity in food communication is often looked at from a negative perspective in terms of conflicting and polarizing voices, however we suggest that this may also take the form of positive, complimentary, and cooperative partnerships. We argue for stakeholders to build complementarities and embrace each one's unique expertise in order to foster objective messages about food and health. Communication about food and health would be ideally shaped by using the guidelines of nutrition experts, the preparation techniques of (celebrity) chefs, and the successful communication strategies of knowledgeable food influencers. Where many individual players nowadays aim to fulfill all of these expert roles, we urge for more cooperation among different stakeholders' unique expertise, without entirely having to forego each individual interest. Strengthening cooperation and improving communication requires an approach that brings the diverse stakeholders in a meaningful way together around the same table.

Herbal smoking products: a systematic content analysis and mapping of the e-retail market.

OBJECTIVE: To assess the online availability and e-marketing strategies of herbal smoking products (HSPs). METHODOLOGY: Google, Yahoo and Bing were searched using relevant keywords related to HSPs. The first 50 records were retrieved and duplicates were removed. Two trained and calibrated authors screened the records according to the eligibility criteria and extracted data from each selected retail-webpage as per the pre-tested data extraction form. RESULTS: Out of the initial 1044 records obtained, 73 retail webpages were finally included. Most of the webpages about HSPs hailed from India followed by the USA. The results showed 24 brands with about 189 flavour variants that are readily available online to all age groups including minors, with price per pack (20 sticks) of herbal cigarettes ranging from INR (₹) 51 to 1830 (median 588). There are no regulations regarding the sale and marketing of HSPs concerning age restrictions and display of health warnings. CONCLUSION: HSPs are readily available online at affordable prices and attractive variants for customers of all ages. The flavour appeal and the health benefit appeal is being used to target minors and young women. There is an urgent need for some regulations on the sale and e-marketing of such products that have an enormous potential to be used as a gateway to tobacco smoking.

Market segmentation of South African adolescent girls and young women to inform HIV prevention product marketing strategy: A mixed methods study.

The uptake of and adherence to HIV prevention products in South Africa has not achieved widespread success. This study aimed to develop a holistic understanding of the psychographics of adolescent girls and young women in South Africa, a primary audience for HIV prevention products, in order to inform market segmentation and marketing strategies. Extensive ethnographic analyses were complemented with a survey (n = 1,500) centered on personal care product journeys. Clustering and qualitative methods yielded six segments with measurable differences, and revealed common themes surrounding empowerment and self-determination, patriarchy, and misinformation risk. The findings enable targeted approaches for HIV prevention product campaigns.

Regulatory Framework of Fortified Foods and Dietary Supplements for Athletes: An Interpretive Approach.

A varied and well-planned diet can meet the nutritional needs of an athlete; however, in certain cases, it could be advisable to increase the intake of some vitamins, minerals or other components through the controlled intake of fortified foods or dietary supplements. In the European Union, a high number of sport foods and supplements are marketed; athletes could at times consume them indiscriminately or even choose products that have not been evaluated and approved by scientific evidence. In this sense, it is necessary to know and interpret the specific regulations for these products in order to make adequate use of them. The aim of this manuscript is to describe the current status of the European regulatory framework, focusing on: (1) regulation of the marketing and labelling of both fortified foods and supplements; (2) regulation of the use of substances used as ingredients in fortified foods; and (3) regulation of nutritional claims and/or health properties associated with nutrients, ingredients and other related substances. This review can facilitate knowledgeable decision making by sports nutrition professionals in order to counsel or manage adequate food choices as well as help consumers make better-informed food decisions. Other experts, such as producers who ensure food safety, might also be interested in this review.

Examining the Prevalence, Nutritional Quality and Marketing of Foods with Voluntary Nutrient Additions in the Canadian Food Supply.

Foods with voluntary nutritional additions are a fast-growing sector of the global food industry. In Canada, while the addition of nutrients to foods has been regulated through fortification regulations, parallel policies which aim to encourage product innovation have also allowed for the voluntary addition of nutrients and other novel ingredients to 'supplemented' and 'functional' foods. Concerns have been raised that the consumption of these products may have negative repercussions on population health, such as high nutrient intakes inappropriate for certain population subgroups (e.g., children) and the shifting of dietary patterns to include more unhealthy foods. The aim of this study was to evaluate the prevalence, nutritional quality, and marketing characteristics of foods with added nutrients in the Canadian market. We found many nutritionally-enhanced foods contained high levels of nutrients beyond recommended intakes, despite these nutrients having no evidence of inadequacy in the Canadian population. Additionally, a large proportion of foods with added nutrients had poor nutrient profiles (were deemed 'less healthy' than their non-enhanced counterparts) and carried heavy marketing on their labels, regardless of their nutritional quality. Taken together these findings raise concerns about foods with voluntary nutrient additions and suggest the need to further investigate consumer attitudes and decision-making towards these foods.

[Conception and practice of "three dimensions and four stages" clinical orientation method for post-marketing evaluation of traditional Chinese medicine].

The article summarized the relevant researches on the clinical orientation of Chinese patent medicines, and put forward the post-marking principle and strategies of the clinical orientation. The principle could be illustrated by four criteria: overall design, step-by-step implementation, from easiness to hardness, gradual concentration. The strategies were as follows: first carrying out the projects with little cost of money and time, and then the projects requiring much cost of money and time, so that the possibility of fai-lure would be put forward at an early stage to reduce the loss caused by research failure as much as possible by consolidating the research projects with less investment at the early stage and gradually increasing the research projects with more investment at the later stage. On this basis, the "three dimensions and four stages" key technology was proposed for the post-marketing clinical orientation of traditional Chinese medicine. Medicines, diseases and patients were the "three dimensions", so we should understand the features and interaction of the target indications, symptoms and population to establish a three-dimensional clinical positioning coordinate system. "Four stages" were the four steps of clues analyzing, hypothesis orientation, preliminary verification and clinical validation. Each latter stage should be started after full completion of the former one, and the latter stage results shall be used to validate and revise the former clinical orientational hypothesis, continuously forming a feedback circle. Based on the sufficient verification of previous study, prospective clinical trials were implemented at last to get the best evidence-based evidence of clinical orientational hypothesis.

[Exploration and practice of post-marketing survival benefit evaluation of Chinese patent medicine for cancer].

Traditional Chinese medicine(TCM) is an important feature of cancer treatment in China. The methods to tap the advantages of TCM, reasonably evaluate and accurately apply Chinese patent medicines have become current research hotspots and difficulties. TCM takes syndrome differentiation and treatment as the core, with the characteristics of overall regulation and multi-targets efficacy. Therefore, the post-marketing survival benefit evaluation of Chinese patent medicines for cancer is different from that in modern medicine. The primary treatment goals in cancer patients include to improve the disease control rate and prolong their survival time. At present, Chinese patent medicines for cancer patients are lacking indepth studies on survival benefit at the post-marketing stage. In addition, the characteristics of individualized treatment with TCM have also increased the complexity of clinical research on TCM. Therefore, it is of certain practical significance and necessity to evaluate the survival benefit of Chinese patent medicines for cancer after marketing. Based on this, in this paper, we first summarized the technical methodological means of survival benefit evaluation at this stage, and then explored the post-marketing survival benefit evaluation of Chinese patent medicines for cancer from three aspects: the evaluation of cancer treatment effect based on survival time and quality of life, treatment-related toxicity and the auxiliary effect of TCM, and the improvement effect for tumor-related symptoms. Based on the practices of early clinical researches, and according to the insufficient efficacy evaluation of current clinical research on Chinese patent medicines, this paper proposed to improve the evaluation system for clinical researches on Chinese patent medicines, establish the evaluation method with TCM characteristics, clarify the dominant population, lay a theoretical foundation for the evaluation of post-marketing survival benefits of Chinese patent medicines for cancer in the future, and promote the modernization process of TCM.