Therapeutic innovation & regulatory science最新文献

{"title":"Turning the Page on Hardcopy Risk Management Plan Educational Materials: Digitalization Made Possible.","authors":"Anabel Ng, Ayn Nova Celo, Beliz Fernandes","doi":"10.1007/s43441-024-00717-3","DOIUrl":"https://doi.org/10.1007/s43441-024-00717-3","url":null,"abstract":"<p><p>'Risk Management Plan Educational Materials' (RMP EMs) are additional risk minimization measures (aRMMs) intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient. While the healthcare sector is embracing various digital tools and platforms for educational and/or awareness building purposes, paper-based materials have remained the mainstay approach for implementation of aRMMs by pharmaceutical companies. Novartis in Singapore conducted a pilot on the feasibility of distributing electronic copies of RMP EMs (e-RMP). Post-pilot, e-RMP was officially implemented in Novartis Singapore. A year following the launch of e-RMP, a survey was performed with healthcare professionals (HCPs) to understand end-users' experience. The survey responses revealed a general preference by both HCPs and patients towards e-RMP. Digital methods of delivering educational aRMMs offer great benefits over traditional paper-based programs. e-RMP significantly reduces the time needed for updated RMP EMs to reach HCPs and their patients/caregivers. This is important to ensure that HCPs and patients/caregivers are made aware of any updates in key safety messages of the products in a timely manner to ultimately ensure patient safety. The successful transition to digital solutions requires purposeful collaborations between key stakeholders of the healthcare ecosystem including regulatory authorities, pharmaceutical companies, HCPs, patients and caregivers. This article aims to provide insights on the digitalization journey of e-RMP, a case study in Singapore, outlining the value but also some of the challenges faced during this transformation.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142717154","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of Borrowing Methods for Incorporating Historical Data in Single-Arm Phase II Clinical Trials.","authors":"Sara Urru, Michela Verbeni, Danila Azzolina, Ileana Baldi, Paola Berchialla","doi":"10.1007/s43441-024-00723-5","DOIUrl":"https://doi.org/10.1007/s43441-024-00723-5","url":null,"abstract":"<p><strong>Background: </strong>Over the last few years, many efforts have been made to leverage historical information in clinical trials. Incorporating historical data into current trials allows for a more efficient design, smaller studies, or shorter duration and may potentially increase the relative amount of information on efficacy and safety. Despite these advantages, it is crucial to select external data sources appropriately to avoid introducing potential bias into the new study. This is where borrowing methods become useful. We illustrate and compare the latest methods of borrowing historical data in a single-arm phase II clinical trial setting, examining their impact on statistical power and type I error.</p><p><strong>Methods: </strong>We implemented static and dynamic versions of the power prior method, incorporating overlapping coefficient and loss functions and meta-analytic predictive priors. These methods were compared with standard and pooling approaches, in which none or all historical data are used.</p><p><strong>Results: </strong>Dynamic borrowing methods achieve lower type I error inflation than pooling. The power prior approach, integrated with overlapping coefficient, allowed for measuring the similarity of the subjects considering their baseline characteristics, thus the likelihood of the data contains information about both confounders and outcome. Using a discounting function to estimate the power parameter guarantees the similarity of historical information and current trial data.</p><p><strong>Conclusion: </strong>We provided a comprehensive overview of borrowing methods, encompassing frequentist and Bayesian approaches as well as static and dynamic technique, to guide researchers in selecting the most appropriate strategy.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142688883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Testing the Feasibility of a Digital Point of Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information.","authors":"Greg Powell, Vijay Kara, Daniel Naranjo, Mangesh Kulkarni, Kerri Best-Sule, Trinka Coster, Machaon Bonafede, Shruti Gangadhar, Lee Kallenbach, Andrew Bate","doi":"10.1007/s43441-024-00711-9","DOIUrl":"https://doi.org/10.1007/s43441-024-00711-9","url":null,"abstract":"<p><p>A digital point-of-care solution was implemented to test the feasibility of near-real-time bi-directional communication between pharmacovigilance experts (PVEs) and healthcare professionals (HCPs) for exchanging unique and informative adverse event (AE) information. The solution was implemented in a commercially available electronic health record (EHR) system/platform, no direct contact between PVEs and the HCPs was possible. The Clinical Affairs team of the EHR vendor was used as an intermediary to ensure appropriate information was exchanged while protecting HCP and patient privacy. The study yielded 9 drug-event pairs of interest (AEI), 2 of which were confirmed as AEs by the HCP. On average it took 20.6 h to receive initial AEI information and 58.8 h to receive follow-up information, which represents a 96% reduction in time compared to current methods. Both interactions provided unique data that would not have been collected otherwise leading to the PVE being able to appropriately determine a potential causal association. This study successfully demonstrated the feasibility of using a compliant, bi-directional, digitally enabled clinical communication channel at the point of care to complement existing pharmacovigilance activities.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142648745","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Better Medicines for Children: Lessons Learnt and Share Learnings at the EFGCP Annual Paediatric Conferences.","authors":"Solange Corriol-Rohou, Sabine Ingeborg Fürst-Recktenwald, Elin-Haf Davies, Martine Dehlinger-Kremer, Mark A Turner","doi":"10.1007/s43441-024-00710-w","DOIUrl":"https://doi.org/10.1007/s43441-024-00710-w","url":null,"abstract":"<p><p>For many years, the European Forum for Good Clinical Practice (EFGCP) Children Medicines Working Party has organised a Paediatric conference annually. In the past, this event was organised jointly with the European Medicines Agency who was used to host it, along with the Drug Information Association (DIA). This conference is the opportunity for all involved in paediatric drug development, i.e., regulators, HTA bodies, patients' representatives, academia and industry, to share learnings and raise awareness about new regulatory requirements of interest to optimise paediatric drug development. The theme of the 2021 conference was \"Challenges and Solutions - the path forward\" while in 2022 it focused on \"Progress made and Continuing Challenges\". Because of the COVID-19 pandemic these two conferences were organised virtually. However, this has not impacted the attendance and value of the conference, since because of a broad and attractive agenda there was a wide stakeholder participation, which provided a compendious overview of the leading issues to improve children's access to innovative medicines.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628584","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for MAGnetic Expansion Control Spinal Rods.","authors":"Jack Filan, Andrew Bowey, Thomas Joyce","doi":"10.1007/s43441-024-00724-4","DOIUrl":"https://doi.org/10.1007/s43441-024-00724-4","url":null,"abstract":"<p><strong>Background: </strong>MAGnetic Expansion Control (MAGEC) rods can prevent repeated lengthening operations for scoliosis patients. However, there have been several Field Safety Notices issued, including a worldwide product recall due to actuator endcap separation. We aimed to review adverse events reported to the Food and Drug Administration (FDA) regarding MAGEC rods, focusing on MAGEC X.</p><p><strong>Methods: </strong>Reports submitted to the Manufacturer and User Facility Device Experience database in relation to MAGEC devices were accessed and analysed using R Statistical Software. Exclusion criteria included duplicate and literature review reports (n = 54). Free-text data were analysed using inductive content analysis.</p><p><strong>Results: </strong>1016 adverse events were reported to 11/30/2023. 99.0% (1006) were submitted by the manufacturer. Reports primarily arose from the UK (465, 45.8%) or US (421, 41.4%). From free-text data the most frequent adverse events were distraction mechanism failure (573), device wear (272), and actuator seal damage (180). Rod fracture (n = 48) was not significantly associated with rod diameter (≤ 5.0 mm or > 5.0 mm), p = 0.736. 234 reports referenced MAGEC X devices; actuator endcap separation was identified in 41.9% (99). Other events include failure of distraction (63), surface damage (31), and rod fracture (15). On 06/30/2020 MAGEC X2 received FDA approval. Twenty reports reference devices manufactured after this date, seven describe distraction mechanism failure; notably there are no reports of endcap separation.</p><p><strong>Conclusion: </strong>These data represent the largest series of adverse events reported for MAGEC rods, including significant new data regarding MAGEC X. As well as endcap separation, failure of distraction, surface damage, and rod fracture were reported.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628617","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Principles for Evaluating the Efficacy and Safety of Ceramic Dental Implants in Japan.","authors":"Tomoya Hara, Yuchi Sato, Hiroyuki Tanishiro, Yukimichi Tamaki, Shunsuke Baba, Eiichi Hirose, Bunsaku Yoshida, Kiyoshi Watanabe, Genki Nishikawa, Daiju Okuda, Madoka Murakami, Yuki Niwa, Masuo Kondoh","doi":"10.1007/s43441-024-00713-7","DOIUrl":"https://doi.org/10.1007/s43441-024-00713-7","url":null,"abstract":"<p><p>Recent progress in materials chemistry has resulted in the development of several ceramic materials that are now being used in dental implants. The advantages of ceramic materials over conventional metallic materials are that they do not induce allergic reactions in individuals with metal allergies, they do not interfere with magnetic resonance imaging, and they provide improved esthetics. In addition, some ceramic materials are tougher than metallic materials and less brittle. However, despite these advantages, few ceramic dental implant materials are currently approved for use in Japan. In FY2022, the Ministry of Health, Labour and Welfare of Japan commissioned a project called the \"Project for the Development of a Guideline for the Evaluation of Ceramic Dental Implants,\" the goal of which was to consider how best to facilitate swift clinical development and approval of emerging ceramic dental implant materials. At a meeting of experts from professional societies, related industry organizations, and government agencies, the issues related to evaluation of the efficacy and safety of ceramic implant were discussed. Here, we summarize the outcomes of that meeting as a set of principles for the premarketing evaluation of ceramic dental implant materials in Japan.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Leveraging Real-World Data in Safety Signal Assessment.","authors":"Vaishali Patadia, Katrin Manlik, Geoffrey Gipson, Jenna C Willis, Ruth Namuyinga, Rachel McDermott, Anita Shaw, Mary K Miller, Julius Asubonteng, Negar Golchin, Stephanie von Klot","doi":"10.1007/s43441-024-00682-x","DOIUrl":"10.1007/s43441-024-00682-x","url":null,"abstract":"<p><strong>Purpose: </strong>TransCelerate BioPharma surveyed its member biopharmaceutical companies to understand current practices and identify opportunities to complement safety signal assessment with rapid real-world data (RWD) analysis.</p><p><strong>Methods: </strong>A voluntary 30-question questionnaire regarding the use of RWD in safety signal assessment was disseminated to subject matter experts at all TransCelerate member companies in July 2022. Responses were blinded, aggregated, summarized, and presented.</p><p><strong>Results: </strong>Eighteen of 20 member companies provided responses to the questionnaire. Sixteen (89%) companies reported actively leveraging RWD in their signal assessment processes. Of 18 respondent companies, 8 (44%) routinely use rapid approaches to RWD analysis, 7 (39%) utilize rapid RWD analysis non-routinely or in a pilot setting, 2 (11%) are considering using rapid RWD analysis, and 1 (6%) has no plans to use rapid RWD analysis for their signal assessment. Most companies reported that RWD adds context to and improves quality of signal assessments. To conduct RWD analysis for signal assessment, 16 of 17 (94%) respondent companies utilize or plan to utilize internally available data, 8 (47%) utilize both internal and external data, and 3 (18%) utilize data networks. Respondents identified key challenges to rapidly performing RWD analyses, including data access/availability, time for analysis execution, and uncertainties regarding acceptance of minimal or non-protocolized approaches by health authorities.</p><p><strong>Conclusion: </strong>Biopharmaceutical companies reported that they see value in the use of rapid RWD analyses for complementing signal assessments. Future work is recommended to offer a framework and process for use of rapid use of RWD analyses in signal assessment.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"1062-1070"},"PeriodicalIF":2.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11530550/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141894374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Using a Quality Management System and Risk-based Approach in Observational Studies to Obtain Robust Real-World Evidence.","authors":"Reo Tanoshima, Naoko Inagaki, Manabu Nitta, Soichiro Sue, Sayuri Shimizu, Tatsuya Haze, Kotaro Senuki, Chihiro Sano, Hajime Takase, Makoto Kaneko, Akito Nozaki, Kozo Okada, Kohei Ohyama, Atsushi Kawaguchi, Yusuke Kobayashi, Hideki Oi, Shin Maeda, Yuichiro Yano, Yuji Kumagai, Etsuko Miyagi","doi":"10.1007/s43441-024-00695-6","DOIUrl":"10.1007/s43441-024-00695-6","url":null,"abstract":"<p><p>The results of observational studies using real-world data, known as real-world evidence, have gradually started to be used in drug development and decision-making by policymakers. A good quality management system-a comprehensive system of process, data, and documentation to ensure quality-is important in obtaining real-world evidence. A risk-based approach is a common quality management system used in interventional studies. We used a quality management system and risk-based approach in an observational study on a designated intractable disease. Our multidisciplinary team assessed the risks of the real-world data study comprehensively and systematically. When using real-world data and evidence to support regulatory decisions, both the quality of the database and the validity of the outcome are important. We followed the seven steps of the risk-based approach for both database selection and research planning. We scored the risk of two candidate databases and chose the Japanese National Database of designated intractable diseases for this study. We also conducted a quantitative assessment of risks associated with research planning. After prioritizing the risks, we revised the research plan and outcomes to reflect the risk-based approach. We concluded that implementing a risk-based approach is feasible for an observational study using real-world data. Evaluating both database selection and research planning is important. A risk-based approach can be essential to obtain robust real-world evidence.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"1006-1013"},"PeriodicalIF":2.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142126740","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of the State of Pharmacovigilance in Secondary Hospitals in the Federal Capital Territory of Nigeria, Using WHO Pharmacovigilance Indicators.","authors":"Augustus Chukwuebuka Ezeodimegwu, Francis Chibuike Iloabuchi, Ifunanya Mary-Ann Onyia, Cynthia Chidubem Eze, Gabriel Ezenri, Princess Chidimma Onyekwuo, Chukwuebuka Vincent Ihemegbulam, Abdulmuminu Isah","doi":"10.1007/s43441-024-00703-9","DOIUrl":"10.1007/s43441-024-00703-9","url":null,"abstract":"<p><strong>Background: </strong>The importance of pharmacovigilance (PV) in ensuring drug safety, especially in the detection and prevention of adverse drug reactions (ADRs) is critical. However, PV activities in Nigeria still face many challenges, such as very low spontaneous reporting rates, and inadequate training and funding. This study assessed the state of pharmacovigilance in the federal capital territory of Nigeria (FCT), using WHO pharmacovigilance indicators.</p><p><strong>Methods: </strong>A cross-sectional questionnaire-based survey was carried out among secondary healthcare facilities in the FCT. The WHO Pharmacovigilance Indicators Questionnaire, which consists of the structural, process and outcome measures, was used to collect data from the focal person for pharmacovigilance at all the consenting facilities. Descriptive statistics were used to summarize all variables. Ethical approval was obtained from the Ethics Review Committee of the FCT development authority.</p><p><strong>Results: </strong>Of the 14 secondary healthcare facilities in the FCT, 11 agreed to the study (response rate = 84.6%). Among the respondents, 4 (36.4%) were females, and 2 (18.2%) had 9 years of experience in pharmacovigilance. For the core structural indicators, 7 (63.6%) of the facilities had a pharmacovigilance center while only 4 (36.4%) had a copy of the Nigerian pharmacovigilance policy. Regarding financial provisions, 10 (90.9%) hospitals reported that there was no regular financial provision for the center while 10 (90.9%) centers had a standard adverse drug reaction reporting form. For the core process indicators, the mean ± SD of the nine core process indicators ranged from 0.9 ± 3.0 to 75.6 ± 38.6 and the total number of reports in the local database, therapeutic ineffectiveness, and medication error were limited.</p><p><strong>Conclusion: </strong>The assessment of pharmacovigilance activities in the Federal Capital Territory of Nigeria revealed significant gaps in infrastructure, financial support, and process implementation. Despite the presence of pharmacovigilance centers in the majority of facilities, the lack of consistent financial support and limited adherence to core process indicators highlight the need for enhanced training, resources, and policy enforcement to improve ADR reporting and overall drug safety monitoring. Strengthening these areas is crucial for advancing pharmacovigilance practices and ensuring patient safety in Nigeria.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"1148-1158"},"PeriodicalIF":2.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142354376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tips for Accelerating BOIN Design.","authors":"Masahiro Kojima, Wu Wende, Henry Zhao","doi":"10.1007/s43441-024-00692-9","DOIUrl":"10.1007/s43441-024-00692-9","url":null,"abstract":"<p><p>During discussions at the Data Science Roundtable meeting in Japan, there were instances where the adoption of the BOIN design was declined, attributed to the extension of study duration and increased sample size in comparison to the 3 + 3 design. We introduce an accelerated BOIN design aimed at completing a clinical phase I trial at a pace comparable to the 3 + 3 design. Additionally, we introduce how we could have applied the BOIN design within our company, which predominantly utilized the 3 + 3 design for most of its clinical oncology dose escalation trials. The accelerated BOIN design is adaptable by using efficiently designated stopping criterion for the existing BOIN framework. Our approach is to terminate the dose escalation study if the number of evaluable patients treated at the current dose reaches 6 and the decision is to stay at the current dose for the next cohort of patients. In addition, for lower dosage levels, considering a cohort size smaller than 3 may be feasible when there are no safety concerns from non-clinical studies. We demonstrate the accelerated BOIN design using a case study and subsequently evaluate the performance of our proposed design through a simulation study. In the simulation study, the average difference in the percentage of correct MTD selection between the accelerated BOIN design and the standard BOIN design was - 2.43%, the average study duration and the average sample size of the accelerated BOIN design was reduced by 14.8 months and 9.22, respectively, compared with the standard BOIN design.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":"1129-1137"},"PeriodicalIF":2.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142112324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}