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Letter to the Editor: Revisit the Combination Validation Test of Tsong et al. for Thorough QT/QTc Clinical Trials

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JOURNAL OF BIOPHARMACEUTICAL STATISTICS 2010年第3期20卷 683-687页

作者： Sun, Guowen (Gordon) Quan, Hui Sanofi Aventis Biostat & Programming Bridgewater NJ 08807 USA

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关键词： Editors letter aluminium Clinical Trial Proof testing

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Benefit-Risk Assessments in Dose-Finding Trials

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STATISTICS IN BIOPHARMACEUTICAL RESEARCH 2010年第2期2卷 153-164页

作者： Quan, Hui Wu, Yujun Ren, Haobo Seko, Noriko Bizet, Florence Koch, Gary Sanofi Aventis Biostat & Programming Bridgewater NJ 08807 USA Regeneron Pharmaceut Inc Biostat & Data Management Bridgewater NJ 08807 USA Sanofi Aventis Biostat & Programming Shinjuku Ku Tokyo 1631488 Japan Sanofi Aventis Biostat & Programming F-92165 Antony France Univ N Carolina Chapel Hill NC 27599 USA

The objective of dose-finding trials is to identify the doses that are sufficiently effective and safe for either future late-phase trials or the ultimate patients. Most methodologies for analyzing data from Phase II dose-finding trials mainly focus on finding the effective doses or minimum effective dose through hypothesis testing, while Phase I studies focus on finding the maximum tolerated dose. In this article, we focus on benefit-risk assessment through both hypothesis testing and point estimation. For purposes of efficiency, monotone dose-response relationships will be assumed for the safety parameter. However, the monotone assumption cannot be made directly for the benefit-risk measure. This consideration can limit the use of downward or upward sequential procedures for multiplicity adjustment for benefit-risk assessment. Several different approaches will be discussed and evaluated. Numerical and data examples will be used to illustrate the properties of these approaches.

关键词： Confidence interval Monotone assumption Multiplicity Restricted estimate

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Effects of famine on placental size and efficiency

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PLACENTA 2011年第5期32卷 395-399页

作者： Roseboom, T. J. Painter, R. C. de Rooij, S. R. van Abeelen, A. F. M. Veenendaal, M. V. E. Osmond, C. Barker, D. J. P. Univ Amsterdam Acad Med Ctr Dept Clin Epidemiol Biostat & Bioinformat NL-1105 AZ Amsterdam Netherlands Univ Med Ctr Utrecht Julius Ctr Hlth Sci & Primary Care NL-3508 GA Utrecht Netherlands Univ Southampton Southampton Gen Hosp MRC Lifecourse Epidemiol Unit Southampton SO16 6YD Hants England King Saud Univ Coll Med Fetal Programming Dis Res Chair Riyadh 11411 Saudi Arabia Univ Amsterdam Acad Med Ctr Dept Obstet & Gynecol NL-1105 AZ Amsterdam Netherlands

Background: Placental growth responds to maternal influences including diet. We have examined placental size, shape and efficiency among babies born around the time of the 5-month wartime famine in Holland 1944-1945. Methods: We examined the birth records of 2414 term singleton babies born in Amsterdam during 1943 -1947. The records included the size of the baby and the thickness of the placental surface, together with its length and breadth which we used to calculate its area and volume. Results: Compared to babies born before the famine babies who were in utero during the famine had smaller placental areas. Babies whose mothers conceived after the famine ended also had smaller placental areas. Famine was associated with a 19 cm(2) decrease in area. Babies who were in mid-late gestation during the famine were 160 g lighter than would have been predicted from their placental area (p < 0.001). Babies who were in early gestation during the famine, or who were conceived after it had ended were 102 g heavier than would have been predicted from their placental area (p < 0.001). These latter babies were either longer or had larger head circumferences depending on when the mother experienced the famine. Among babies who were in early gestation during the famine the reduction in placental area was greater in boys than girls (p for interaction 0.03). Conclusion: Famine impaired the normal processes of placentation, even among babies who were conceived after it had ended. In babies who were in mid-late gestation during the famine, the placenta was less efficient. In babies who were in early gestation during the famine, or who were conceived after it had ended, the placenta was more efficient. The placentas of boys and girls responded differently to famine. (C) 2011 Elsevier Ltd. All rights reserved.

关键词： Fetal programming Placenta Dutch famine Sex differences

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The sex-specific effects of famine on the association between placental size and later hypertension

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PLACENTA 2011年第9期32卷 694-698页

作者： van Abeelen, A. F. M. de Rooij, S. R. Osmond, C. Painter, R. C. Veenendaal, M. V. E. Bossuyt, P. M. M. Elias, S. G. Grobbee, D. E. van der Schouw, Y. T. Barker, D. J. P. Roseboom, T. J. Univ Amsterdam Acad Med Ctr Dept Clin Epidemiol Biostat & Bioinformat NL-1105 AZ Amsterdam Netherlands Univ Med Ctr Utrecht Julius Ctr Hlth Sci & Primary Care NL-3508 GA Utrecht Netherlands Univ Southampton Southampton Gen Hosp MRC Lifecourse Epidemiol Unit Southampton SO16 6YD Hants England Univ Amsterdam Acad Med Ctr Dept Obstet & Gynecol NL-1105 AZ Amsterdam Netherlands King Saud Univ Coll Med Fetal Programming Dis Res Chair Riyadh 11411 Saudi Arabia

Background: People who had low birth weight are at increased risk of hypertension. This may reflect fetal programming by undernutrition. Placental size is also associated with hypertension. Maternal undernutrition during the Dutch famine reduced placental surface area. We examined whether maternal undernutrition altered the relationship between placental size and later hypertension. Methods: Retrospective cohort study among 860 subjects born in Amsterdam during 1943-47. 216 subjects were taking anti-hypertensive medication. Birth records included placental length and breadth from which we calculated its area. Results: Among men who were not in utero during the famine hypertension was associated with a small placental surface area due to a small placental breadth, and with an oval-shaped surface. The OR for hypertension was 0.83 (95% CI 0.70 to 1.00) for a 40 cm(2) increase in surface area. Among men who were in utero during the famine hypertension was associated with a large placental surface area due to a large placental breadth, and with a round-shaped surface. The OR for hypertension was 1.34 (95% CI 0.99 to 1.80) for a 40 cm(2) increase in surface area. The associations between placental size and hypertension in men who were and were not in utero during the famine were significantly different (p values for interaction = 0.008 for placental surface area, 0.001 for the breadth and 0.01 for the difference in the two diameters). Among women hypertension was not associated with placental size. Conclusions: Our study provides the first direct evidence that changes in maternal diet during pregnancy alter the relationship between placental size and later hypertension among men but not women. We suggest that among men who were not ill utero during the famine, hypertension was related to impaired implantation, whereas among men who were in utero during the famine it was related to compensatory expansion of the placental surface. (C) 2011 Elsevier Ltd. All rights reserved.

关键词： Fetal programming Placenta Hypertension Dutch famine Sex differences

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Concordance between clinician and patient ratings as predictors of response, remission, and recurrence in major depressive disorder

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JOURNAL OF PSYCHIATRIC RESEARCH 2011年第1期45卷 96-103页

作者： Dunlop, Boadie W. Li, Thomas Kornstein, Susan G. Friedman, Edward S. Rothschild, Anthony J. Pedersen, Ron Ninan, Philip Keller, Martin Trivedi, Madhukar H. Emory Univ Dept Psychiat Sch Med Atlanta GA 30306 USA Wyeth Res Global Biostat & Programming Collegeville PA USA Wyeth Res Global Med Affairs Collegeville PA USA Virginia Commonwealth Univ Dept Psychiat Richmond VA USA Univ Pittsburgh Sch Med Dept Psychiat Pittsburgh PA USA Univ Massachusetts Sch Med Dept Psychiat Worcester MA 01655 USA UMass Mem Hlth Care Worcester MA USA Brown Univ Dept Psychiat & Human Behav Providence RI 02912 USA Univ Texas SW Med Sch Dallas TX USA

We conducted a secondary analysis of data from the Prevention of Recurrent Episodes of Depression With Venlafaxine Extended Release (ER) for Two Years (PREVENT) trial to evaluate whether discrepancies between clinician and patient ratings of depression severity were predictive of response, remission, and recurrence during treatment for a depressive episode. Patients who self-rated depression severity in concordance with the clinician ("concordant patients") were defined as having a standardized patient-rated Inventory of Depressive Symptoms-Self Report (IDS-SR30) score minus standardized clinician-rated Hamilton Rating Scale for Depression (HAM-D-17) score <1 SD from mean. Non-concordant patients ("underrating patients" [-1 SD], "overrating patients" [+1 SD]) were identified. Cohorts were compared for remission and response on the HAM-D-17, Clinician Global Impression-Severity (CGI-S), and IDS-SR30 during acute and continuation therapy and time to recurrence during maintenance therapy. During acute treatment female patients were more likely to overrate their depression severity compared to the clinician;older age predicted overrating during continuation treatment. Overrating patients had a slower onset of response on the HAM-D-17 during acute treatment (P = 0.004). There were no differences between cohorts for remission or response on the HAM-D-17 or CGI-S. Overrating patients at week 10 had lower remission and response rates on the IDS-SR30 during continuation therapy (32% and 50%, respectively;P <= 0.001) compared with underrating patients (76%, 77%) or concordant patients (64%, 78%). Patient concordance at the end of continuation therapy did not predict recurrence during maintenance therapy, indicating that patient rating scales may be useful in tracking recurrence during maintenance therapy. Poor agreement between patient- and clinician-ratings of depression severity is primarily a state phenomenon, although it is trait-like for some patients. (C) 2010 Elsevier

关键词： Depression Psychiatric status rating scales Reliability and validity Outcome assessment Treatment outcome Anxiety

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Pharmacokinetic Variability of Long-Acting Stimulants in the Treatment of Children and Adults with Attention-Deficit Hyperactivity Disorder

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CNS DRUGS 2010年第12期24卷 1009-1025页

作者： Ermer, James C. Adeyi, Ben A. Pucci, Michael L. Shire Dev Inc Pharmaceut Sci Clin Pharmacol & Pharmacokinet Wayne PA USA Shire Dev Inc Biostat & Stat Programming Wayne PA USA Ogilvy CommonHlth Sci Commun Med Affairs Parsippany NJ USA

Methylphenidate- and amfetamine-based stimulants are first-line pharmacotherapies for attention-deficit hyperactivity disorder, a common neurobehavioural disorder in children and adults. A number of long-acting stimulant formulations have been developed with the aim of providing once-daily dosing, employing various means to extend duration of action, including a transdermal delivery system, an osmotic-release oral system, capsules with a mixture of immediate-and delayed-release beads, and prodrug technology. Coefficients of variance of pharmacokinetic measures can estimate the levels of pharmacokinetic variability based on the measurable variance between different individuals receiving the same dose of stimulant (interindividual variability) and within the same individual over multiple administrations (intraindividual variability). Differences in formulation clearly impact pharmacokinetic profiles. Many medications exhibit wide interindividual variability in clinical response. Stimulants with low levels of inter- and intraindividual variability may be better suited to provide consistent levels of medication to patients. The pharmacokinetic profile of stimulants using pH-dependent bead technology can vary depending on food consumption or concomitant administration of medications that alter gastric pH. While delivery of methylphenidate with the transdermal delivery system would be unaffected by gastrointestinal factors, intersubject variability is nonetheless substantial. Unlike the beaded formulations and, to some extent (when considering total exposure) the osmotic-release formulation, systemic exposure to amfetamine with the prodrug stimulant lisdexamfetamine dimesylate appears largely unaffected by such factors, likely owing to its dependence on systemic enzymatic cleavage of the precursor molecule, which occurs primarily in the blood involving red blood cells. The high capacity but as yet unidentified enzymatic system for conversion of lisdexamfetamine dimesylate

关键词： TREATMENT of attention-deficit hyperactivity disorder NEUROBEHAVIORAL disorders DISEASE risk factors PATIENT monitoring PHARMACOKINETICS MEDICAL research TREATMENT

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Genetic Associations for Activated Partial Thromboplastin Time and Prothrombin Time, their Gene Expression Profiles, and Risk of Coronary Artery Disease

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AMERICAN JOURNAL OF HUMAN GENETICS 2012年第1期91卷 152-162页

作者： Tang, Weihong Schwienbacher, Christine Lopez, Lorna M. Ben-Shlomo, Yoav Oudot-Mellakh, Tiphaine Johnson, Andrew D. Samani, Nilesh J. Basu, Saonli Goegele, Martin Davies, Gail Lowe, Gordon D. O. Tregouet, David-Alexandre Tan, Adrian Pankow, James S. Tenesa, Albert Levy, Daniel Volpato, Claudia B. Rumley, Ann Gow, Alan J. Minelli, Cosetta Yarnell, John W. G. Porteous, David J. Starr, John M. Gallacher, John Boerwinkle, Eric Visscher, Peter M. Pramstaller, Peter P. Cushman, Mary Emilsson, Valur Plump, Andrew S. Matijevic, Nena Morange, Pierre-Emmanuel Deary, Ian J. Hicks, Andrew A. Folsom, Aaron R. Univ Minnesota Div Epidemiol & Community Hlth Minneapolis MN 55454 USA European Acad Bozen Bolzano EURAC Ctr Biomed I-39100 Bolzano Italy Univ Ferrara Dept Expt & Diagnost Med I-44121 Ferrara Italy Univ Edinburgh Ctr Cognit Ageing & Cognit Epidemiol Edinburgh EH8 9JZ Midlothian Scotland Univ Edinburgh Dept Psychol Edinburgh EH8 9JZ Midlothian Scotland Univ Bristol Sch Social & Community Med Bristol BS8 2PS Avon England Univ Paris 06 INSERM UMR S 937 Inst Cardiometab & Nutr ICAN F-75013 Paris France NHLBI Framingham Heart Study Framingham MA 01702 USA NHLBI Ctr Populat Studies Bethesda MD 20824 USA NHLBI Div Intramural Res Bethesda MD 20824 USA Univ Leicester Glenfield Hosp Dept Cardiovasc Sci Leicester LE3 9QP Leics England Leicester Cardiovasc Biomed Res Unit Glenfield Hosp Natl Inst Hlth Res Leicester LE3 9QP Leics England Univ Minnesota Div Biostat Minneapolis MN 55455 USA Univ Glasgow Inst Cardiovasc & Med Sci Glasgow G12 8TA Lanark Scotland Inst Genet & Mol Med Med Res Council MRC Human Genet Unit Edinburgh EH4 2XU Midlothian Scotland Univ Edinburgh Royal Dick Sch Vet Studies Roslin Inst Roslin EH25 9RG Midlothian Scotland Queens Univ Belfast Epidemiol Res Grp Belfast BT12 6BJ Antrim North Ireland Univ Edinburgh Med Genet Sect Edinburgh EH4 2XU Midlothian Scotland Univ Edinburgh Alzheimer Scotland Dementia Res Ctr Edinburgh EH8 9JZ Midlothian Scotland Cardiff Univ Sch Med Dept Primary Care & Publ Hlth Cardiff CF14 4XN S Glam Wales Univ Texas Hlth Sci Ctr Houston Ctr Human Genet Houston TX 77030 USA Univ Texas Hlth Sci Ctr Houston Human Genome Sequencing Ctr Houston TX 77030 USA Queensland Inst Med Res Brisbane Qld 4029 Australia Gen Cent Hosp Dept Neurol I-39100 Bolzano Italy Univ Lubeck Dept Neurol D-23538 Lubeck Germany Univ Vermont Dept Med Burlington VT 05405 USA Univ Vermont Dept Pathol Burlington VT 05405 USA Merck & Co Inc Mol Programming & Res Informat Rahway NJ 07065 USA Merck Res Lab Dept Cardiova

Activated partial thromboplastin time (aPTT) and prothrombin time (PT) are clinical tests commonly used to screen for coagulation-factor deficiencies. One genome-wide association study (GWAS) has been reported previously for aPTT, but no GWAS has been reported for PT. We conducted a GWAS and meta-analysis to identify genetic loci for aPTT and PT. The GWAS for aPTT was conducted in 9,240 individuals of European ancestry from the Atherosclerosis Risk in Communities (ARIC) study, and the GWAS for PT was conducted in 2,583 participants from the Genetic Study of Three Population Microisolates in South Tyrol (MICROS) and the Lothian Birth Cohorts (LBC) of 1921 and 1936. Replication was assessed in 1,041 to 3,467 individuals. For aPTT, previously reported associations with KNG1, HRG, F11, F12, and ABO were confirmed. A second independent association in ABO was identified and replicated (rs8176704, p = 4.26 x 10(-24)). Pooling the ARIC and replication data yielded two additional loci in F5 (rs6028, p = 3.22 x 10(-9)) and AGBL1 (rs2469184, p = 3.61 x 10(-8)). For PT, significant associations were identified and confirmed in F7 (rs561241, p = 3.71 x 10(-56)) and PROCR/EDEM2 (rs2295888, p = 5.25 x 10(-13)). Assessment of existing gene expression and coronary artery disease (CAD) databases identified associations of five of the GWAS loci with altered gene expression and two with CAD. In summary, eight genetic loci that account for similar to 29% of the variance in aPTT and two loci that account for similar to 14% of the variance in PT were detected and supported by functional data.

关键词： PARTIAL thromboplastin time PROTHROMBIN time GENE expression CORONARY heart disease -- Risk factors BLOOD coagulation HUMAN genome DNA replication

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Assessing consistent treatment effect in a multi-regional clinical trial: a systematic review

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PHARMACEUTICAL STATISTICS 2010年第3期9卷 242-253页

作者： Chen, Joshua Quan, Hui Binkowitz, Bruce Ouyang, S. Peter Tanaka, Yoko Li, Gang Menjoge, Shailendra Ibia, Ekopimo Merck Res Labs N Wales PA USA Sanofi Aventis Biostat & Programming Bridgewater NJ USA Celgene Summit NJ USA Eli Lilly Indiapolis IN USA Johnson & Johnson Raritan NJ USA Boehringer Ingelheim GmbH & Co KG Ridgefield CT USA

A key issue in multi-regional clinical trials (MRCTs) is how to assess the consistency of treatment effect across regions, although there is no a priori reason to believe that the treatment effect should vary across the regions. In this article, we define the research question as an assessment of overall consistency across all regions for which all regions are considered equally important. This is different from the region/country-specific analyses (e. g. US vs Non-US), which are frequently requested by local regulatory agencies and usually performed for multiple agencies. We provide a systematic review of methods that may potentially be used for assessing consistency across regions, including commonly used quantitative/qualitative interaction tests, Japanese Pharmaceutical Medical Device Agency (PMDA) Methods 1 & 2, and those proposed for different purposes (e. g. bridging studies, meta-analysis, and vaccine lot consistency, among others). These methods are classified into three groups: global methods, multivariate quantitative methods, and multivariate qualitative methods. A case study is used to illustrate these methods. We also provide recommendations on how to choose appropriate methods and incorporate them in the study design. Copy right (C) 2010 John Wiley & Sons, Ltd.

关键词： multi-regional clinical trial consistency heterogeneity quantitative qualitative

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Assessment of Consistency of Treatment Effects in Multiregional Clinical Trials

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DRUG INFORMATION JOURNAL 2010年第5期44卷 617-632页

作者： Quan, Hui Li, Mingyu Chen, Joshua Gallo, Paul Binkowitz, Bruce Ibia, Ekopimo Tanaka, Yoko Ouyang, Soo Peter Luo, Xiaolong Li, Gang Menjoge, Shailendra Talerico, Steven Ikeda, Kimitoshi Sanofi Aventis Biostat & Programming Bridgewater NJ 08807 USA Boehringer Ingelheim GmbH & Co KG Ingelheim Germany

Multiregional clinical trials (MRCTs) present great opportunities but also challenges to the trial community. To address the challenges and fully realize the opportunities, a PhRMA MRCT Cross-Functional Key Issue Team (KIT) was formed in 2008. One of the work streams within the KIT particularly focuses on the assessment of consistency of treatment effects across regions. As the main objective of this work stream, this research explores a number of definitions for consistency assessments. We address the issues primarily for superiority trials with continuous endpoints, then extend briefly to noninferiority trials, random effect models, binary endpoints, and survival endpoints. Computations and simulations are used to study the properties of the proposed definitions, particularly the power for showing consistency. To illustrate applications of the methods, we use a trial example with a continuous endpoint. We discuss considerations for trial design as well as for data analysis. The consistency assessment relies heavily on the definition of regions and the number of regions. We recommend working with health authorities to define region in a manner that is sensible from a practical interpretation standpoint and also makes region consistency assessment a feasible undertaking.

关键词： Ethnic effect Sample size Power Noninferiority Interaction Random effect model

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Clinical Response and Symptomatic Remission in Children Treated With Lisdexamfetamine Dimesylate for Attention-Deficit/Hyperactivity Disorder

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CNS SPECTRUMS 2010年第9期15卷 559-568页

作者： Findling, Robert L. Adeyi, Ben Chen, Gary Dirks, Bryan Babcock, Thomas Scheckner, Brian Lasser, Robert Pucci, Michael L. Abdullah, Huda I. McGough, James J. Univ Hosp Case Med Ctr Div Child & Adolescent Psychiat Cleveland OH 44106 USA Shire Dev Inc Biostat & Stat Programming Dept Wayne PA USA Shire Dev Inc Stat Programming Wayne PA USA Shire Dev Inc Clin Dev & Med Affairs Wayne PA USA Shire Dev Inc Sci Publicat Wayne PA USA Shire Dev Inc Clin Dev & Med Affairs Wayne PA USA Hlth Learning Syst Parsippany NJ USA Univ Calif Los Angeles Semel Inst Neurosci & Human Behav Los Angeles CA USA Univ Calif Los Angeles David Geffen Sch Med Los Angeles CA 90095 USA

Objective: To examine clinical response and symptomatic remission in two studies of lisdex-amfetamine dimesylate (LDX) in children with attention-deficit/hyperactivity disorder (ADHD). Methods: In a 4-week, placebo-controlled, double-blind trial, children 6-12 years of age with ADHD received LDX (30-70 mg/ day) or placebo. In an open-label trial, children from previous studies were titrated to optimal dose over 4 weeks and maintained up to 1 year. Primary and secondary efficacy assessments were the ADHD Rating Scale IV (ADHD-RS-IV) and Clinical Global Impressions-Improvement (CGI-I) scale, respectively. Clinical response was defined as >= 30% reduction in ADHD-RS-IV total score with a CGI-I rating of 1 or 2;symptomatic remission was defined by ADHD-RS-IV total score <= 18. Results: In the 4-week study (N=285), at any postdose assessment, 79.3% achieved response (median 13 days) and 67.1% achieved remission (median 22 days) with LDX versus 29.2% and 23.6% with placebo. In the long-term study (N=251), at any postdose assessment, 96.0% responded and 62.7% maintained response;88.8% achieved remission and 46.4% maintained remission. Conclusion: Most children treated with LDX achieved clinical response and symptomatic remission at one time point;once achieved, almost half maintained remission.

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