標(biāo)題: Titlebook: Real-World Evidence in Medical Product Development; Weili He,Yixin Fang,Hongwei Wang Book 2023 The Editor(s) (if applicable) and The Autho [打印本頁] 作者: ODDS 時間: 2025-3-21 18:21
書目名稱Real-World Evidence in Medical Product Development影響因子(影響力)
書目名稱Real-World Evidence in Medical Product Development影響因子(影響力)學(xué)科排名
書目名稱Real-World Evidence in Medical Product Development網(wǎng)絡(luò)公開度
書目名稱Real-World Evidence in Medical Product Development網(wǎng)絡(luò)公開度學(xué)科排名
書目名稱Real-World Evidence in Medical Product Development被引頻次
書目名稱Real-World Evidence in Medical Product Development被引頻次學(xué)科排名
書目名稱Real-World Evidence in Medical Product Development年度引用
書目名稱Real-World Evidence in Medical Product Development年度引用學(xué)科排名
書目名稱Real-World Evidence in Medical Product Development讀者反饋
書目名稱Real-World Evidence in Medical Product Development讀者反饋學(xué)科排名
作者: 粉筆 時間: 2025-3-21 23:37 作者: antidote 時間: 2025-3-22 04:15
https://doi.org/10.1007/978-3-031-26328-6real-world evidence; real-world data; design bias; confounding control; regulatory science; machine learn作者: Ruptured-Disk 時間: 2025-3-22 06:38
978-3-031-26330-9The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerl作者: Ganglion-Cyst 時間: 2025-3-22 10:48 作者: 和藹 時間: 2025-3-22 16:36 作者: debouch 時間: 2025-3-22 19:14
Overview of the Current Real-World Evidence Regulatory Landscaperld. We will first outline the key concepts underpinning evaluation of real-world evidence and discuss similarity and differences in those concepts in guidance documents from different countries. Then, we illustrate the regulatory practice of using real-world data throughout the product development 作者: 錯事 時間: 2025-3-22 23:28
Key Considerations in Forming Research Questions and Conducting Research in Real-World Settingred through real-world studies and the analysis of real-world data. The derived real-world evidence may be used to help support approval of a new indication for a medical product that has already been approved or to help support postapproval study requirements. We also discuss how to revise the rese作者: 直覺沒有 時間: 2025-3-23 02:13 作者: Tartar 時間: 2025-3-23 08:40
Key Variables Ascertainment and Validation in RW Settingam. ., 2018). Key variables are those that define a key patient characteristic necessary to identify the study population of interest, the treatment/exposure, the outcome, or a key confounder whose effect must be adjusted for. With Real-World Data (RWD), often (1) exposure, outcomes, and key confoun作者: FADE 時間: 2025-3-23 12:48 作者: 沙發(fā) 時間: 2025-3-23 17:36
Privacy-Preserving Record Linkage for Real-World Dataic health records (EHRs), claims activities, and patient registries. It is of great interest to aggregate and link data of the same patients from several data sources to provide a more comprehensive longitudinal evaluation of treatments from different aspects. Privacy-Preserving Record Linkage (PPRL作者: 雇傭兵 時間: 2025-3-23 21:00 作者: 小說 時間: 2025-3-24 01:08
Estimand in Real-World Evidence Study: From Frameworks to Applicationon five attributes—target population, treatment, endpoint, intercurrent events, and population-level summary. Although the addendum states that the principles are also applicable to single-arm trials and observational studies, constructing estimands for real-world evidence (RWE) studies might requir作者: 多產(chǎn)魚 時間: 2025-3-24 03:36 作者: 單獨 時間: 2025-3-24 07:43 作者: GEON 時間: 2025-3-24 14:27
Innovative Hybrid Designs and Analytical Approaches Leveraging Real-World Data and Clinical Trial Dareatment effectiveness and safety. RWD can serve to augment the trial data in a variety of ways including the analysis population, the treatments considered, the variables on each subject, or the follow-up time. These approaches include using RWD as external controls to complement single arms trials作者: 有常識 時間: 2025-3-24 15:14
Statistical Challenges for Causal Inference Using Time-to-Event Real-World Datal trials, or to augment a small internal control arm in a phase II trial. Using RWD for causal inference is a difficult task due to the lack of treatment randomization. RWD with time-to-event (henceforth referred to as TTE RWD) outcomes present extra challenges since causal effect estimands for TTE 作者: 品嘗你的人 時間: 2025-3-24 22:27
Sensitivity Analyses for Unmeasured Confounding: This Is the Waye assumption of ‘no unmeasured confounders’. While researchers have long been aware of the potential bias from unmeasured confounders, recently many new approaches have been proposed to quantitatively assess the robustness of research to the potential for unmeasured confounding. These include a grow作者: arsenal 時間: 2025-3-25 02:42
Sensitivity Analysis in the Analysis of Real-World Datan estimator to deviations from its underlying modeling assumptions and limitations in the data.” We start with an anatomy of potential assumptions behind an answerable research question. Then, we discuss how to conduct sensitivity analysis to explore the robustness of inferences to deviations from t作者: Heterodoxy 時間: 2025-3-25 06:13
Personalized Medicine with Advanced Analyticsally true as continued innovation in science and technology are delivering multiple interventions with different mechanism of actions for related comorbidity conditions. Real-world data (RWD) which typically includes a large, diverse, and heterogeneous patient population presents unique opportunity 作者: dermatomyositis 時間: 2025-3-25 09:10
The Need for Real-World Evidence in Medical Product Development and Future Directions drug development, given the increasing uptake of RWE across regulatory, industry, and academia globally. Great progresses have been made in the last few years in this field, which we will review and summarize. Further, we will provide our thoughts on the further opportunities to address continued challenges and future directions.作者: 憤世嫉俗者 時間: 2025-3-25 14:46 作者: 未開化 時間: 2025-3-25 18:37
ters on estimand, causal inference roadmap, fit-for-purpose .This book provides state-of-art statistical methodologies, practical considerations from regulators and sponsors, logistics, and real use cases for practitioners for the uptake of RWE/D. Randomized clinical trials have been the gold standa作者: HEAVY 時間: 2025-3-25 21:59 作者: 磨碎 時間: 2025-3-26 03:28
Estimand in Real-World Evidence Study: From Frameworks to Application serve as guiding principles for defining real-world estimands. This chapter also provides examples of constructing an appropriate estimand in RWE studies, with detailed description on each of the five estimand attributes outlined in ICH E9(R1).作者: aneurysm 時間: 2025-3-26 08:16
Book 2023ractitioners for the uptake of RWE/D. Randomized clinical trials have been the gold standard for the evaluation of efficacy and safety of medical products. However, the cost, duration, practicality, and limited generalizability have incentivized many to look for alternative ways to optimize drug dev作者: multiply 時間: 2025-3-26 09:27
Key Considerations in Forming Research Questions and Conducting Research in Real-World Setting generate real-world data for research purpose. In category two, based on one or several existing real-world data sources, we design a retrospective real-world study. In category three, we utilize real-world data in the design, conduct, and analysis of clinical trials.作者: 蛤肉 時間: 2025-3-26 15:14 作者: 費解 時間: 2025-3-26 19:48 作者: 記憶 時間: 2025-3-27 00:11
Sensitivity Analysis in the Analysis of Real-World Dataconclude the chapter by emphasizing the difference between sensitivity analysis and supplementary analysis, which is defined in ICH E9(R1) as “a general description for analyses that are conducted in addition to the main and sensitivity analysis with the intent to provide additional insights into the understanding of the treatment effect.”作者: Crepitus 時間: 2025-3-27 02:32 作者: 娘娘腔 時間: 2025-3-27 05:32 作者: 我們的面粉 時間: 2025-3-27 09:27
Weili He,Yixin Fang,Hongwei Wang,Charles Leeel elements and the radioactive products formed simultaneously. Research programs to develop a technique for the separation of the slow-neutron fissionable U. isotope from its much more abundant naturally occurring isotope, U., were carried out in two other installations in Oak Ridge. The first of t作者: 迎合 時間: 2025-3-27 14:12 作者: 啞劇 時間: 2025-3-27 21:27
Nigel Hughes,Dipak Kalraory-based quantitative methods reveal that levels of pleiotropy and epistasis are in-line with theoretical expectations. The results of the magnified “glaucoma” region of the network confirm the existence of well-documented interactions, supported by overlapping genes and biological pathways and mor作者: 開始從未 時間: 2025-3-27 23:45 作者: 聾子 時間: 2025-3-28 03:36
ation and relevant variable selection methods in marginal and joint paradigms, respectively, under a variety of conceptual models. Discussions on strengths and limitations, as well as computational aspects of the variable selection methods tailored for G?×?E studies, have also been provided.作者: 搜集 時間: 2025-3-28 08:17 作者: Legend 時間: 2025-3-28 13:12
Ying Wu,Hongwei Wang,Jie Chen,Hana Leeersuaded, in the course of lecturing on epistemology to under- graduates, that not everything was as clear as it should be, that there were gaps in my presentation that were seriously in need of filling.978-90-481-8396-8978-94-015-7697-0Series ISSN 0166-6991 Series E-ISSN 2542-8292 作者: Perceive 時間: 2025-3-28 18:40 作者: LASH 時間: 2025-3-28 19:35
Lisa V. Hampson,Rima Izem forms, in particular, that permit a specific coherent unfolding of the deep information content of the Source. Therefore, the simulation models, if valid, materialise as "creative" channels, i.e., as autonomous functional systems, as the very roots of a new possible development of the entire system作者: Cloudburst 時間: 2025-3-29 02:51
Yixin Fang,Weili He forms, in particular, that permit a specific coherent unfolding of the deep information content of the Source. Therefore, the simulation models, if valid, materialise as "creative" channels, i.e., as autonomous functional systems, as the very roots of a new possible development of the entire system作者: PANG 時間: 2025-3-29 04:16
Hongwei Wang,Dai Feng,Yingyi Liu forms, in particular, that permit a specific coherent unfolding of the deep information content of the Source. Therefore, the simulation models, if valid, materialise as "creative" channels, i.e., as autonomous functional systems, as the very roots of a new possible development of the entire system作者: 浪費物質(zhì) 時間: 2025-3-29 09:45 作者: Firefly 時間: 2025-3-29 13:14 作者: 松果 時間: 2025-3-29 15:50
Douglas Fariesontent of the Source. Therefore, the simulation models, if valid, materialise as "creative" channels, i.e., as autonomous functional systems, as the very roots of a new possible development of the entire system978-94-007-9724-6978-94-007-6013-4Series ISSN 0921-3384 Series E-ISSN 2352-2119 作者: ODIUM 時間: 2025-3-29 19:46
Rima Izem,Ruthanna Davi,Jingyu Julia Luan,Margaret Gamalo作者: interference 時間: 2025-3-30 03:46
Real-World Evidence in Medical Product Development作者: arterioles 時間: 2025-3-30 07:46 作者: 不愛防注射 時間: 2025-3-30 10:25 作者: 有抱負(fù)者 時間: 2025-3-30 15:59
Key Variables Ascertainment and Validation in RW Setting field, requiring natural language processing techniques such as information extraction be applied; (4) misclassification is a concern, requiring validation studies. This chapter will cover the above topics and walk through an example study for which the ascertainment of key variables was found to b作者: strain 時間: 2025-3-30 20:31 作者: 掙扎 時間: 2025-3-30 21:42
Causal Inference with Targeted Learning for Producing and Evaluating Real-World Evidence data acquisition, estimation and inference using targeted minimum loss-based likelihood estimation and super learning; and (5) sensitivity analysis to quantify the robustness of study findings and level of support in the data for the substantive conclusion, including violations of the identificatio作者: TAP 時間: 2025-3-31 00:58 作者: Infect 時間: 2025-3-31 07:53 作者: lattice 時間: 2025-3-31 09:58
Sensitivity Analyses for Unmeasured Confounding: This Is the Wayps in any quantitative assessment of robustness to unmeasured confounding. We also argue that given these broadly applicable methods and published R-packages to remove implementation complexity, consistent application of quantitative sensitivity analyses is now practical.作者: 有惡意 時間: 2025-3-31 14:46
Personalized Medicine with Advanced Analyticsnfounding and quantify potential complex relationship between intervention and outcome. Therefore, advanced analytics are usually more suitable when addressing personalized medicine research questions. A few active areas include predictive modeling, natural language processing for free text to augme作者: 東西 時間: 2025-3-31 20:03
s with the uptake of RWE/D, including, but not limited to, applications in regulatory and non-regulatory settings, causal inference methodologies, organization and infrastructure considerations, logistic challenges, and practical use cases..978-3-031-26330-9978-3-031-26328-6作者: dagger 時間: 2025-3-31 21:49
