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real-world evidence in Localized Pancreatic: Coping with Uncertainty in Unselected Populations

Journal of Cancer Therapy 2024年第4期15卷 164-178页

作者： María I. Pamies Ramón Diana Ibarra Anguita Paula Rodríguez Payá Alvaro Muñoz Abad David Sánchez García María Valero Revert Beatriz Grau Mirete Mariano Martínez Marín Alicia Calero Amaro Lorena Rodríguez Cazalla Javier Gallego Plazas Medical Oncology Department Elche University Hospital Elche (Alicante) Spain General Surgery Department Elche University Hospital Elche (Alicante) Spain General Surgery Department Vega Baja Hospital Orihuela (Alicante) Spain

Background: Localized pancreatic cancer, including resectable (R), borderline resectable (BR) and locally advanced unresectable disease (LAU), is considered in clinical guidelines for diverse treatment options based on clinical trials in selected populations. Hence, exploring with real world evidence (RWE) clinicians’ preferences for treatment options and their results seems pertinent. Methods: In a set of consecutive patients with localized pancreatic cancer assisted in a third level hospital from January 2013 to December 2022, medical records, symptoms, diagnostic process, distribution between subtypes, and treatment plans, with safety and efficacy results, were assessed. Results: A total of 152 patients with localized disease were included (43.4% R, 21.0% BR, 33.6% LAU). The population characteristics exemplified differences between daily practice and clinical trials. Tumor location and symptoms were as expected. Treatment plan was conditioned by PS or comorbidities in 23.0% of patients. In patients with R disease, surgery followed by different adjuvant chemotherapy (CT) regimes was the antineoplastic treatment of choice (64.8%) with efficacy results (OS 37.5 months;95% CI 18.4 - 56.7), in the range of contemporary standards. The common use of neoadjuvant CT for BR disease (94.4%), with surgery in 50% of them, and its results (OS 30.8 months;95% CI 10.5 - 51.2) reflected current controversies of treatment recommendations and evolution in this scenario. Paliative CT with or without radiotherapy was the standard specific treatment in LAU disease (95.1%) with survival results (PFS: 10.8 months;95% CI 8.8 - 12.7. OS: 20.3 months;95% CI 13.5 - 27.2) that justify the distinct character and the specific study of this entity. Conclusion: RWE for localized pancreatic cancer aroused from the analysis of this population confirms the distinct nature of patients assisted in daily practice, as well as mirrors the complexity of decision making in clinical assumptions in which a

关键词： real-world evidence Localized Pancreatic Cancer

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real-world evidence on adjuvant chemotherapy in older adults with stage II/III colon cancer

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world Journal of Gastrointestinal Oncology 2020年第6期12卷 604-618页

作者： Atul Batra Rodrigo Rigo Dropen Sheka Winson Y Cheung Department of Medicine Tom Baker Cancer CentreCalgaryAlberta T2N 1N4Canada Department of Oncology University of CalgaryCalgaryAlberta T 2N 4N2Canada

Colon cancer represents one of the most common cancers diagnosed in older adults *** standard of care in resected stage II and stage III colon cancer continues to *** there is unequivocal evidence to suggest both disease free and overall survival benefits with the use of combination chemotherapy in patients with stage III colon cancer,data regarding its use in patients with stage II colon cancer are less ***,although colon cancer is a disease that affects older adults,there is considerable debate on the value of adjuvant chemotherapy in the aging *** particular,many older patients are undertreated when compared to their younger *** this review,we will describe the clinical trials that contributed to the current adjuvant chemotherapy approach in colon cancer,discuss representation of older adults in trials and the specific challenges associated with the management of this subpopulation,and highlight the role of comprehensive geriatric *** will also review how real-world evidence complements the data gaps from clinical trials of early stage colon cancer.

关键词： Colon cancer Older adults Adjuvant chemotherapy real-world evidence

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Adjuvant radiotherapy in central hepatocellular carcinoma after narrow-margin hepatectomy:A 10-year real-world evidence

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Chinese Journal of Cancer Research 2020年第5期32卷 645-653页

作者： Weiqi Rong Weibo Yu Liming Wang Fan Wu Kai Zhang Bo Chen Chengli Miao Liguo Liu Songlin An Changcheng Tao Weihu Wang Jianxiong Wu Department of Hepatobiliary Surgery National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Department of Pathology and Laboratory Medicine David Geffen School of MedicineUniversity of California Los AngelesLos AngelesCA 90095USA Department of Radiation Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Department of Retroperitoneal Tumor Surgery Peking University International HospitalBeijing 102206China Department of General Surgery China-Japan Friendship HospitalBeijing 100029China Department of Peritoneal Cancer Surgery Beijing Shijitan HospitalCapital Medical University BeijingBeijing 100038China Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing) Department of Radiation OncologyPeking University Cancer Hospital&InstituteBeijing 100142China

Objective:A prospective randomized control study investigated the feasibility and efficacy of adjuvant radiotherapy on patients with central hepatocellular carcinoma(HCC)after narrow-margin hepatectomy(real-world evidence to further characterize the role of adjuvant ***:Patients with central HCC after narrow-margin hepatectomy(<1 cm)were prospectively assigned to adjuvant radiotherapy group and control ***'outcome,adverse events,long-term recurrence and survival rates were ***:The 1-,5-,and 10-year recurrence-free survival(RFS)rates were 81.0%,43.9%,and 38.7%,respectively in adjuvant radiotherapy group and 71.7%,35.8%,and 24.2%,respectively in control group(log-rank test,P=0.09).The 1-,5-,and 10-year overall survival(OS)rates were 96.6%,54.7%,and 42.8%,respectively in adjuvant radiotherapy group and 90.2%,55.1%,and 30.0%,respectively in control group(log-rank test,P=0.20).The 1-,5-,and 10-year RFS rates for patients with small HCC(≤5 cm)were 91.1%,51.6%,and 48.4%,respectively in adjuvant radiotherapy group and 80.0%,36.6%,and 26.6%,respectively in control group(log-rank test,P=0.03).Landmark analysis demonstrated that patients with small HCC in adjuvant radiotherapy group had a significantly improved OS in second five years after treatment in comparison to patients in control group(log-rank test,P=0.05).Conclusions:Our updated results showed a sustained clinical benefit on reducing recurrence,improving longterm survival for small central HCC by adjuvant radiotherapy after narrow-margin ***-term survival data also indicated that hepatectomy is an optimal treatment for selected patients with central HCC.

关键词： Three-dimensional conformal radiotherapy recurrence long-term survival narrow-margin hepatectomy real-world evidence

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Application of real-world evidence in Regulatory Decision-Making for Medical Devices

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Asian Journal of Social Pharmacy 2021年第3期16卷 230-237页

作者： Huang Xianqin Chen Chuhan Dong Li School of Business Administration Shenyang Pharmaceutical UniversityShenyang 110016China

Objective To understand the real-world study(RWS)and its application in domestic and foreign pharmaceutical device regulatory decision-making,so as to promote its further application in the decision-making of medical devices supervision in *** Literature analysis and comparative analysis were used to compare the real-world evidence(RWE)and randomized controlled trials to obtain the development status of medical devices in China and the United *** and Conclusion It is found that the application of RWS in the field of medical devices has many advantages,which can make up for the deficiencies of traditional clinical *** addition,the RWE has a wide range of applications in the field of medical devices in *** recent years,the RWE has received extensive attention in the medical field in the United *** FDA has issued related guidelines,and its applications have gradually formed a complete *** on RWE will become the development trend of clinical evaluation of medical devices in the *** attaching importance to the development of the RWE,China should learn from the specifications of relevant foreign organizations to improve its development in the field of health.

关键词： real-world evidence randomized controlled trial medical device supervision

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EU real-world evidence Supports New Drug Research and Development Decisions and Its Implications for China

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Asian Journal of Social Pharmacy 2021年第3期16卷 197-202页

作者： Yang Lingling Xu Fengxiang School of Business Administration Shenyang Pharmaceutical UniversityShenyang110016China Research Institute of Drug Regulatory Science Shenyang Pharmaceutical UniversityShenyang110016China

Objective To analyze the application of EU real-world evidence in the decision-making of new drug research and development(R&D),and to provide policy recommendations for China’s government to make new drug R&D *** The relevant policy documents of the EU on the development of new drugs and other domestic and foreign literature on the real-world evidence were analyzed to obtain the role and application of the current EU real-world evidence in the implementation of new drug development *** and Conclusion At present,the EU is carrying out the national synchronous scientific advisory policy,urging the formation of a European innovation framework,and providing decision-making for new drug R&D selection and program design based on real-world *** is recommended that China build a real-world medical database and design a new drug screening platform to help companies,scientific research institutions assess target *** addition,a national scientific advisory platform should be set up to integrate scientific research strength and provide technical support for new drug R&D institutions.

关键词： EU real-world evidence R&D decision-making R&D policy

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The Enlightenment of EU real-world evidence Supporting the Inclusion of Rare Disease Drugs in Medical Insurance Decisions to China

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Asian Journal of Social Pharmacy 2021年第3期16卷 209-213页

作者： Yu Zhongyi Xu Fengxiang School of Business Administration Shenyang Pharmaceutical UniversityShenyang110016China Research Institute of Drug Regulatory Science Shenyang Pharmaceutical UniversityShenyang110016China

Objective To study the use of real-world evidence by EU and its member states for establishing a strategy for rare diseases and provide references for the inclusion of orphan drugs in China’s medical *** A case analysis method was used to introduce the EU’s decision to include rare disease drugs in medical insurance by using real-world evidence because clinical data of rare diseases were difficult to *** and Conclusion China can use real-world evidence to make medical insurance decisions based on the experience of the EU and continue to invest more in rare diseases,which can solve the problem of few drugs for patients with rare disease.

关键词： EU real-world evidence rare disease medical insurance

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Current Situation and Prospect of the Application of real-world evidence in Health Care

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Asian Journal of Social Pharmacy 2023年第4期18卷 374-386页

作者： Xiao Feiyi Zhang Fang Li Xue Dong Li School of Business Administration Shenyang Pharmaceutical UniversityShenyang 110016China ZTE Foundation Shenzhen 518055China Health Development Research Center of the National Health Commission Beijing 100044China

Objective To summarize the application of real-world evidence(RWE)in the medical and healthcare field of various countries,including relevant policies,application scenarios and application *** Relevant policies and application scenarios were obtained by consulting the official websites and public documents of various countries’healthcare *** literature retrieval was adopted to search PubMed,EMBASE,Cochrane Library,CNKI,CBM and Wanfang databases,and all papers related to real-world study and application were ***,these papers were classified and analyzed by country and application *** and Conclusion The RWE was mainly applied to supporting the preliminary approval of a new drug,expanding drug indications,accelerating approval or supporting conditional marketing authorizations and drug safety evaluation,*** United Kingdom,the United States,Germany,the Netherlands,Italy,Sweden,and France admitted RWE,but they treated the data obtained from RWE with *** systematic literature retrieval,a total of 701 articles were obtained,including relevant studies from 36 countries,among which the United States published 264 in *** most common study was about using real-world data(RWD)to calculate treatment-related costs,which had a total of 259 ***,158 articles were used for epidemiological ***,138 articles were about establishing risk models to analyze disease risk factors.A total of 70 articles were real-world efficacy evaluation of the drug treatment schemes,54 articles were about pharmacoeconomic evaluation with RWD as parameters.A total of 29 articles used RWD to build predictive models,and 15 articles used RWD to evaluate the health-related quality of life in *** application of RWE has been used widely in the medical and healthcare field of various *** application scenarios are gradually diversified,the application methods of RWD become mature,and the evidence qualit

关键词： real-world data real-world evidence real-world study medical and health care

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real-world evidence Supporting New Drug Review and Approval in European Union and Its Enlightenment to China

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Asian Journal of Social Pharmacy 2021年第3期16卷 203-208页

作者： Lan Yipeng Huang Zhe School of Business Administration Shenyang Pharmaceutical UniversityShenyang110016China Research Institute of Drug Regulatory Science Shenyang Pharmaceutical UniversityShenyang110016China

Objective To analyze the application of real-world evidence(RWE)in the field of medicine in European Union,and provide suggestions for RWE supporting the review and approval of new drugs in *** The European Medicines Agency(EMA)and other databases were used to search relevant documents for analyzing the European Union’s new drug review and approval process with the support of *** and Conclusion The European Union carrying out new drug review and approval with the support of RWE has just *** decision-making process includes three stages such as new drug research and development,review,and ***,there are some challenges in data quality,research methods,evidence sufficiency,and research process of RWE supporting the European Union in reviewing and approving new *** present,RWE can accurately grasp the clinical effects of drugs and improve the safety and effectiveness in the process of assisting the review and approval of new *** the same time,RWE also can promote the development and application of Traditional Chinese Medicine(TCM)and help find out the potential value of TCM such as new indications.

关键词： real-world evidence new drug review and approval European Union enlightenment

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How real-world evidence Supports Healthcare Decisions in EU and Its Enlightment to China

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Asian Journal of Social Pharmacy 2021年第3期16卷 238-241页

作者： Li Longxiao Lian Guiyu School of Business Administration Shenyang Pharmaceutical UniversityShenyang 110016China

Objective To summarize the concept,background,application value of real-world evidence(RWE)and its enlightenment to China based on the analysis of the information about the RWE supporting health decision in the European Union,and to provide a reference for Chinese health *** Through literature research and data collection,the requirements of EU countries,especially some typical countries,for clinical evidence in health decision were obtained,and the application of RWE in supporting health decision in EU was analyzed with specific *** and Conclusion RWE plays an increasingly important role in supplementing the evidence base of clinical trials,verifying the safety and effectiveness of medical devices,and accelerating the market access of new *** the improvement of RWE quality,RWE will not only be used in the evaluation of biological agents and chemical drugs,but also play an important role in the evaluation of traditional Chinese medicine and the post-marketing evaluation of medical devices.

关键词： real-world evidence EU health decision enlightment

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Research on real-world evidence and Application in EU and Its Enlightment to China

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Asian Journal of Social Pharmacy 2021年第3期16卷 219-224页

作者： Wang Chao Lian Guiyu School of Business Administration Shenyang Pharmaceutical UniversityShenyang 110016China

Objective To analyze the research and application status of real-world evidence(RWE)in the European Union(EU)and provide a reference for China’s *** By consulting the policy guidelines issued by EU EMA and the documents of European countries at home and abroad,the basic principles and case notes of EU RWE implementation were comprehensively *** and Conclusion Research on RWE in EU is mainly carried out from four aspects:R&D decision,application of expanded trial certificate,medical insurance decision,and supervision decision,which plays an important role in the progress of European clinical ***,researchers in China should draw lessons from these four perspectives and design reasonable research directions and programs.

关键词： EU real-world evidence R&D decision health care decision regulatory decision

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