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Practical Considerations and Approaches for Emerging Issues in Benefit-risk Assessment of Medical Products

STATISTICS IN BIOPHARMACEUTICAL RESEARCH 2016年第4期8卷 365-365页

作者： He, Weili Chan, Ivan Jiang, Qi Merck & Co Inc Clin Biostat Kenilworth NJ 07033 USA AbbVie Pipeline Stat & Programming Data & Stat Sci N Chicago IL USA Amgen Inc Global Biostat Sci Thousand Oaks CA 91320 USA

An introduction is presented in which the editor discusses various reports within the issue on topics including changes in benefit-risk (BR) assessment guidelines, patient-centric approach to BR evaluation, and the ro... 详细信息

关键词： MEDICAL equipment safety measures MEDICAL supplies STATISTICIANS SAFETY measures

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Thirty-Day Readmissions in Hospitalized Patients Who Received Bezlotoxumab With Antibacterial Drug Treatment for Clostridium difficile Infection

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CLINICAL INFECTIOUS DISEASES 2017年第7期65卷 1218-1221页

作者： Prabhu, Vimalanand S. Cornely, Oliver A. Golan, Yoav Dubberke, Erik R. Heimann, Sebastian M. Hanson, Mary E. Liao, Jane Pedley, Alison Dorr, Mary Beth Marcella, Stephen Merck & Co Inc Ctr Real World & Observat Studies Econ & Data Sci Kenilworth NJ USA Univ Cologne Clin Trials Ctr Cologne Dept Internal Med Cologne Excellence Cluster Cellular Stress Respon Cologne Germany Tufts Univ Sch Med Dept Med Geog Med & Infect Dis Boston MA 02111 USA Washington Univ Sch Med Div Infect Dis St Louis MO 63110 USA Univ Hosp Cologne Dept Internal Med Cologne Germany Merck & Co Inc Global Sci & Med Publicat Infect Dis & Vaccines Kenilworth NJ USA Merck & Co Inc Stat Programming Ctr Outcomes Res Excellence Kenilworth NJ USA Merck & Co Inc Late Dev Stat Biostat Kenilworth NJ USA Merck & Co Inc Infect Dis Clin Res Kenilworth NJ USA Merck & Co Inc Acute Hosp & Specialty Care Ctr Outcomes Res Excellence Outcomes Res Kenilworth NJ USA

We estimated 30-day all-cause and Clostridium difficile infection (CDI)-associated hospital readmissions in participants at high risk of recurrent CDI enrolled in MODIFY I/II. Bezlotoxumab-treated inpatients experienced fewer CDI-associated readmissions compared with placebo-treated inpatients, notably in participants aged >= 65 years and with severe CDI.

关键词： C. difficile infection recurrence hospital readmissions bezlotoxumab

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The Locommotion Study (MMY4001): A Prospective, Multinational Study of RealLife Current Standards of Care in Patients with Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including PI, IMiD, and CD38 Monoclonal Antibody Treatment and Documented Disease Progression

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BLOOD 2019年 134卷 5549-5549页

作者： Delforge, Michel Moreau, Philippe Mateos, Maria-Victoria De Stefano, Valerio Weisel, Katja San-Miguel, Jesus Einsele, Hermann Facon, Thierry Boccadoro, Mario Goldschmidt, Hartmut Cavo, Michele Rosinol, Laura Kaiser, Martin F. Gay, Francesca Scheid, Christof Broyl, Annemiek Van De Donk, Niels W. C. J. Rodriguez, Paula Potamianou, Anna Sakabedoyan, Caline Strulev, Vadim Nesheiwat, Tonia Bergmans, Paul Rizvi, Syed Pilatowicz, Arkadiusz Sonneveld, Pieter Univ Hosp UZ Leuven Dept Hematol Leuven Belgium Univ Hosp Hotel Dieu Clin Hematol Nantes France Univ Hosp Salamanca Inst Canc Mol & Cellular Biol Salamanca Spain Univ Cattolica Ist Ematol Rome Italy Univ Med Ctr Hamburg Eppendorf Dept Med 2 Hamburg Germany Clin Univ Navarra Dept Hematol CIMA IDISNA Pamplona Spain Univ Klinikum Wurzburg Med Klin & Poliklin 2 Wurzburg Germany Hop Claude Huriez Hosp Huriez Serv Malad Sang Lille France AOU Citta Salute & Sci Torino Div Hematol 1 Dept Oncol Turin Italy Heidelberg Univ Heidelberg Germany Bologna Univ Seragnoli Inst Hematol Sch Med Bologna Italy Hosp Clin Barcelona Inst Hematol & Oncol Dept Hematol IDIBAPS Barcelona Spain Inst Canc Res London England Univ Torino Div Hematol Turin Italy Univ Cologne Dept Internal Med 1 Cologne Germany Univ Cologne Ctr Integrated Oncol Cologne Bonn Cologne Germany Erasmus MC Canc Inst Dept Hematol Rotterdam Netherlands Vrije Univ Amsterdam Amsterdam UMC Dept Hematol Canc Ctr Amsterdam Amsterdam Netherlands Clin Univ Navarra Pamplona Spain Janssen Cilag EMEA Med Affairs Neuss Germany Janssen Cilag EMEA Med Affairs Beirut Lebanon Janssen Pharmaceut NV EMEA Med Affairs Beerse Belgium Legend Biotech USA Piscataway NJ USA Janssen Cilag Biostat & Programming Breda Netherlands Janssen Cilag EMEA Med Affairs Operat Warsaw Poland Erasmus MC Canc Inst Rotterdam Netherlands

5549

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Sample Size Calculation for Count Data in Comparative Clinical Trials with Nonuniform Patient Accrual and Early Dropout

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JOURNAL OF BIOPHARMACEUTICAL STATISTICS 2015年第1期25卷 1-15页

作者： Li, Huiling Wang, Lin Wei, Lynn Quan, Hui Harborside Financial Ctr Forest Res Inst Dept Stat Sci Jersey City NJ 07311 USA Sanofi Dept Biostat & Programming Bridgewater NJ USA

In clinical trials with counts of recurrent event data, it is often of particular interest to test whether the experimental treatment reduces the event rate in comparison with a control. The sample size calculation for such a trial often assumes fixed follow-up time for each patient. In many trials, however, we follow all patients for a predetermined follow-up time after the end of the accrual period, in which case the follow-up time is variable. This article provides methods for sample size calculation for clinical trials with ordinary Poisson count data and variable follow-up time allowing for nonuniform accrual and early dropouts. We also generalize the sample size formula to count data with overdispersion.

关键词： Overdispersion Nonuniform accrual Event rate Count data Sample size

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A QUANTITATIVE METHOD FOR WEIGHT SELECTION IN SGDDP

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JOURNAL OF BIOPHARMACEUTICAL STATISTICS 2015年第6期25卷 1179-1189页

作者： Huang, Qin Chen, Gang Yuan, Zhilong Zhang, Ying Wenrich, Judy SFDA Off Biostat Ctr Drug Evaluat Beijing 100038 Peoples R China Johnson & Johnson Consumer Prod Inc Biostat & Programming Raritan NJ USA Penn State Univ Dept Stat State Coll PA USA

Ethnic factors pose major challenge to evaluating the treatment effect of a new drug in a targeted ethnic (TE) population in emerging regions based on the results from a multiregional clinical trial (MRCT). To address this issue with statistical rigor, Huang et al. (2012) proposed a new design of a simultaneous global drug development program (SGDDP) which used weighted Z tests to combine the information collected from the nontargeted ethnic (NTE) group in the MRCT with that from the TE group in both the MRCT and a simultaneously designed local clinical trial (LCT). An important and open question in the SGDDP design was how to downweight the information collected from the NTE population to reflect the potential impact of ethnic factors and ensure that the effect size for TE patients is clinically meaningful. In this paper, we will relate the weight selection for the SGDDP to Method 1 proposed in the Japanese regulatory guidance published by the Ministry of Health, Labour and Welfare (MHLW) in 2007. Method 1 is only applicable when true effect sizes are assumed to be equal for both TE and NTE groups. We modified the Method 1 formula for more general scenarios, and use it to develop a quantitative method of weight selection for the design of the SGDDP which, at the same time, also provides sufficient power to descriptively check the consistency of the effect size for TE patients to a clinically meaningful magnitude.

关键词： Bridging Ethnic factors Drug development MRCT Weighted Z test

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Maternal Diet, Gestational Weight Gain, and Inflammatory Markers During Pregnancy

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OBESITY 2016年第10期24卷 2133-2139页

作者： Hrolfsdottir, Laufey Schalkwijk, Casper G. Birgisdottir, Bryndis E. Gunnarsdottir, Ingibjorg Maslova, Ekaterina Granstrom, Charlotta Strom, Marin Olsen, Sjurdur F. Halldorsson, Thorhallur I. Univ Iceland Landspitali Univ Hosp Unit Nutr Res Reykjavik Iceland Univ Iceland Fac Food Sci & Nutr Reykjavik Iceland Statens Serum Inst Dept Epidemiol Res Ctr Fetal Programming Copenhagen Denmark Maastrich Univ Med Ctr Lab Metab & Vasc Med Dept Internal Med Maastricht Netherlands Imperial Coll Dept Epidemiol & Biostat London England Danish Diabet Acad Odense Denmark Univ Faroe Islands Fac Nat & Hlth Sci Torshavn Faroe Islands Denmark Harvard Sch Publ Hlth Dept Nutr Boston MA USA

Objective: To examine the associations of gestational weight gain (GWG) and diet with low-grade inflammation in pregnancy. Methods: A cross-sectional analysis of 671 pregnant women was performed, and diet was assessed in gestational week 30. GWG was recorded in weeks 30 and similar to 37 (difference between the weight recorded at these time points and pre-pregnancy weight). Markers of inflammation, high-sensitivity C-reactive protein (hsCRP), serum amyloid A (SAA), interleukin (IL)-6, IL-8, IL-1 beta, and tumor necrosis factor-alpha were quantified in serum from week 30. Results: After adjusting for age, pre-pregnancy BMI, parity, smoking status, and education, each 1 kg increase in GWG was associated with 3% (95% CI: 1-5) higher hsCRP and 3% (95% CI: 1-4) higher SAA concentrations, which corresponded to similar to 18% to 25% increase in these biomarkers among those with excessive weight gain. GWG was inversely associated with IL-8 while no associations were found for the other inflammatory markers. With respect to diet, women in the highest compared with lowest quintile of protein intake had 26% (95% CI: 3-54) higher hsCRP concentrations. This increase appeared to be driven by intake of animal protein. A similar pattern was observed for SAA. Conclusions: Excessive GWG, as well as high intake of animal protein, was associated with higher concentrations of inflammatory factors.

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Cabazitaxel plus prednisolone with primary prophylaxis with pegfilgrastim (PEG) in Japanese patients with metastatic castration-resistant prostate cancer: An open label prospective phase 2 study

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ANNALS OF ONCOLOGY 2017年 28卷 x160-x161页

作者： Uemura, H. Kosaka, T. Sumitomo, M. Harada, K. Sugimoto, M. Hayashi, N. Yoshimura, K. Fukasawa, S. Ecstein-Fraisse, E. B. Sunaga, Y. Oya, M. Yokohama City Univ Med Ctr Dept Urol Renal Transplantat Yokohama Kanagawa Japan Keio Univ Hosp Dept Urol Tokyo Japan Aichi Med Univ Hosp Dept Urol Nagakute Aichi Japan Kobe Univ Hosp Dept Urol Kobe Hyogo Japan Kagawa Univ Hosp Dept Urol Miki Kagawa Japan Yokohama City Univ Med Dept Urol Yokohama Kanagawa Japan Kindai Univ Hosp Dept Urol Osaka Japan Chiba Canc Ctr Dept Urol Prostate Canc Chiba Japan Sanofi France Med Paris France Sanofi Japan Biostat & Programming Tokyo Japan

519P

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Adaptive estimation for varying coefficient models

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JOURNAL OF MULTIVARIATE ANALYSIS 2015年 137卷 17-31页

作者： Chen, Yixin Wang, Qin Yao, Weixin Genzyme Corp Dept Biostat & Programming Cambridge MA 02142 USA Univ Calif Riverside Dept Stat Riverside CA 92521 USA Virginia Commonwealth Univ Dept Stat Sci & Operat Res Richmond VA 23284 USA

In this article, a novel adaptive estimation is proposed for varying coefficient models. Unlike the traditional least squares based methods, the proposed approach can adapt to different error distributions. An efficient EM algorithm is provided to implement the proposed estimation. The asymptotic properties of the resulting estimator are established. Both simulation studies and real data examples are used to illustrate the finite sample performance of the new estimation procedure. The numerical results show that the gain of the new procedure over the least squares estimation can be quite substantial for non-Gaussian errors. (C) 2015 Elsevier Inc. All rights reserved.

关键词： Adaptive estimation EM algorithm Kernel smoothing Local maximum likelihood Varying coefficient models

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Plasma Concentrations of Ferritin in Early Pregnancy Are Associated with Risk of Gestational Diabetes Mellitus in Women in the Danish National Birth Cohort

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JOURNAL OF NUTRITION 2016年第9期146卷 1756-1761页

作者： Bowers, Katherine A. Olsen, Sjurdur F. Bao, Wei Halldorsson, Thorhallur I. Strom, Marin Zhang, Cuilin Cincinnati Childrens Hosp Med Ctr Dept Pediat Div Biostat & Epidemiol Cincinnati OH 45229 USA Statens Serum Inst Dept Epidemiol Res Ctr Fetal Programming Copenhagen Denmark Harvard TH Chan Sch Publ Hlth Dept Nutr Boston MA USA Eunice Kennedy Shriver Natl Inst Child Hlth & Hum Epidemiol Branch Div Intramural Populat Hlth Res Rockville MD USA Univ Iowa Coll Publ Hlth Dept Epidemiol Iowa City IA USA Univ Iceland Fac Food Sci & Nutr Raykjavik Iceland Univ Faroe Islands Fac Nat & Hlth Sci Torshavn Faroe Islands Denmark

Background: Evidence from experimental studies has demonstrated that higher than normal iron concentrations can lead to pancreatic beta cell dysfunction and impaired glucose metabolism. Studies on body iron stores in early pregnancy and subsequent gestational diabetes mellitus (GDM) risk are sparse. Objective: Our objective was to determine whether biomarkers of body iron stores measured in early pregnancy are associated with GDM risk. Methods: A case-control study of 350 GDM cases and 349 non-GDM controls was conducted in participants from the Danish National Birth Cohort. Blood was collected at a mean +/- SD gestational age of 9.4 +/- 3.2 wk. Plasma biomarkers of iron stores, including ferritin and soluble transferrin receptor (sTfR), were measured. Logistic regression was used to estimate the OR of GDM associated with quintiles of plasma biomarkers of body iron stores, controlling for maternal age, family history of diabetes, exercise in pregnancy, parity, and prepregnancy body mass index (BM). Results: Cases were older (mean +/- SD age: 32.2 +/- 4.3 compared with 29.9 +/- 4.2 y) and had a higher BMI (in kg/m(2);mean SD: 28.7 +/- 6.0 compared with 24.1 +/- 4.6) than controls. Plasma concentrations of both ferritin and sTfR in early pregnancy were significantly higher in GDM cases than in controls [means +/- SDs: 80.6 +/- 56.0 compared with 71.8 +/- 50.1 mu g/L (P = 0.03) and 1.5 +/- 0.7 compared with 1.4 +/- 0.6 mg/L (P = 0.002) for ferritin and sTfR, respectively]. Ferritin was positively and significantly associated with GDM risk even after adjustment for major risk factors of GDM, including prepregnancy BMI. ORs across increasing quintiles of ferritin were 1.00 (reference), 1.25 (95% CI: 0.70, 2.22), 1.89 (95% CI: 1.06, 3.37), 0.82 (95% CI: 0.46, 1.48), and 2.34 (95% CI: 1.30, 4.21) (P-linear trend = 0.02). Conclusion: These findings suggest that plasma ferritin measured in early pregnancy is significantly and positively associated with GDM risk.

关键词： iron biomarkers pregnancy gestational diabetes mellitus plasma ferritin

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Analytical and statistical comparability of generic enoxaparins from the US market with the originator product

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JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS 2015年 115卷 431-442页

作者： Mourier, Pierre A. J. Agut, Christophe Souaifi-Amara, Hajer Herman, Frederic Viskov, Christian Sanofi F-94403 Vitry Sur Seine France Sanofi R&D F-34184 Montpellier France Experis IT Life Sci F-92723 Nanterre France Sanofi CMC Biostat & Programming Ctr Rech Vitry Sur Seine F-94403 Vitry Sur Seine France

Low-molecular-weight heparins (LMWHs) are complex anticoagulant drugs, made from heparin porcine mucosa starting material. Enoxaparin sodium manufactured by Sanofi is one of the most widely prescribed LMWHs and has been used since 1993 in the USA. In 2010, US Food and Drug Administration approval for supplying generic enoxaparin was granted to Sandoz and subsequently to Amphastar. Little is known, however, of the differences in composition of these preparations. In this study, samples from several batches of generic enoxaparins were purchased on the US market and analyzed with state of the art methodologies, including disaccharide building blocks quantification, nuclear magnetic resonance (NMR), and a combination of orthogonal separation techniques. Direct high-performance liquid chromatography analysis of the different enoxaparin batches revealed distinct process fingerprints associated with each manufacturer. Disaccharide building block analysis showed differences in the degree of sulfation, the presence of glycoserine derivatives, as well as in proportions of disaccharides. Results were compared by statistical approaches using multivariate analysis with a partial least squares discriminant analysis methodology. The variations were statistically significant and allowed a clear distinction to be made between the enoxaparin batches according to their manufacturer. These results were further confirmed by orthogonal analytical techniques, including NMR, which revealed compositional differences of oligosaccharides both in low- and high-affinity antithrombin fractions of enoxaparin. (C) 2015 The Authors. Published by Elsevier B.V.

关键词： Analytical comparability Disaccharide quantification Enoxaparin Generic Chemometrics Nuclear magnetic resonance

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