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2. Quantitative in vitro to in vivo extrapolation of genotoxicity data provides protective estimates of in vivo dose

Author

Beal, Marc A., primary, Audebert, Marc, additional, Barton‐Maclaren, Tara, additional, Battaion, Hannah, additional, Bemis, Jeffrey C., additional, Cao, Xuefei, additional, Chen, Connie, additional, Dertinger, Stephen D., additional, Froetschl, Roland, additional, Guo, Xiaoqing, additional, Johnson, George, additional, Hendriks, Giel, additional, Khoury, Laure, additional, Long, Alexandra S., additional, Pfuhler, Stefan, additional, Settivari, Raja S., additional, Wickramasuriya, Shamika, additional, and White, Paul, additional

Published
2022
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3. Carboxymethyl chitosan prolongs adenovirus‐mediated expression of IL ‐10 and ameliorates hepatic fibrosis in a mouse model

Author

Gou, Yannian, primary, Weng, Yaguang, additional, Chen, Qian, additional, Wu, Jinghong, additional, Wang, Hao, additional, Zhong, Jiamin, additional, Bi, Yang, additional, Cao, Daigui, additional, Zhao, Piao, additional, Dong, Xiangyu, additional, Guo, Meichun, additional, Wagstaff, William, additional, Hendren‐Santiago, Bryce, additional, Chen, Connie, additional, Youssef, Andrew, additional, Haydon, Rex C., additional, Luu, Hue H., additional, Reid, Russell R., additional, Shen, Le, additional, He, Tong‐Chuan, additional, and Fan, Jiaming, additional

Published
2022
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5. Rethinking developmental toxicity testing: Evolution or revolution?

Author

Scialli, Anthony R, Daston, George, Chen, Connie, Coder, Prägati S, Euling, Susan Y, Foreman, Jennifer, Hoberman, Alan M, Hui, Julia, Knudsen, Thomas, Makris, Susan L, Morford, LaRonda, Piersma, Aldert H, Stanislaus, Dinesh, Thompson, Kary E, Sub RIVM, dIRAS RA-1, Sub RIVM, and dIRAS RA-1

Subjects
0301 basic medicine, Embryology, Reproductive toxicology, Health, Toxicology and Mutagenesis, hypothesis-based testing, Developmental toxicity, Embryonic Development, Toxicology, Risk Assessment, Article, Fetal Development, 03 medical and health sciences, Testing protocols, Pregnancy, Toxicity Tests, Adverse Outcome Pathway, Animals, Humans, virtual embryo, Technical committee, Segment II, adverse outcome pathways, Test (assessment), 030104 developmental biology, Risk analysis (engineering), Background current, embryo-fetal toxicity testing, Pediatrics, Perinatology and Child Health, Female, developmental toxicity testing, Developmental Biology, Dose selection
Abstract

Background Current developmental toxicity testing adheres largely to protocols suggested in 1966 involving the administration of test compound to pregnant laboratory animals. After more than 50 years of embryo-fetal development testing, are we ready to consider a different approach to human developmental toxicity testing? Methods A workshop was held under the auspices of the Developmental and Reproductive Toxicology Technical Committee of the ILSI Health and Environmental Sciences Institute to consider how we might design developmental toxicity testing if we started over with 21st century knowledge and techniques (revolution). We first consider what changes to the current protocols might be recommended to make them more predictive for human risk (evolution). Results The evolutionary approach includes modifications of existing protocols and can include humanized models, disease models, more accurate assessment and testing of metabolites, and informed approaches to dose selection. The revolution could start with hypothesis-driven testing where we take what we know about a compound or close analog and answer specific questions using targeted experimental techniques rather than a one-protocol-fits-all approach. Central to the idea of hypothesis-driven testing is the concept that testing can be done at the level of mode of action. It might be feasible to identify a small number of key events at a molecular or cellular level that predict an adverse outcome and for which testing could be performed in vitro or in silico or, rarely, using limited in vivo models. Techniques for evaluating these key events exist today or are in development. Discussion Opportunities exist for refining and then replacing current developmental toxicity testing protocols using techniques that have already been developed or are within reach.

Published
2018

7. Efficacy and safety of tofacitinib for the treatment of rheumatoid arthritis in patients from the Asia‐Pacific region: Post‐hoc analyses of pooled clinical study data

Author

Lee, Eun Bong, primary, Yamanaka, Hisashi, additional, Liu, Yi, additional, Tsai, Wen‐Chan, additional, Chen, Connie, additional, Kwok, Kenneth, additional, Yoo, Hyun–Jeong, additional, Llamado, Lyndon J., additional, Wang, Lisy, additional, Luo, Yingchun, additional, Sugiyama, Naonobu, additional, and Tanaka, Yoshiya, additional

Published
2019
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9. Herpes Zoster and Tofacitinib: Clinical Outcomes and the Risk of Concomitant Therapy

Author

Winthrop, Kevin L., primary, Curtis, Jeffrey R., additional, Lindsey, Stephen, additional, Tanaka, Yoshiya, additional, Yamaoka, Kunihiro, additional, Valdez, Hernan, additional, Hirose, Tomohiro, additional, Nduaka, Chudy I., additional, Wang, Lisy, additional, Mendelsohn, Alan M., additional, Fan, Haiyun, additional, Chen, Connie, additional, and Bananis, Eustratios, additional

Published
2017
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12. Treatment of advanced thyroid cancer with axitinib: Phase 2 study with pharmacokinetic/pharmacodynamic and quality‐of‐life assessments

Author

Locati, Laura D., primary, Licitra, Lisa, additional, Agate, Laura, additional, Ou, Sai‐Hong I., additional, Boucher, Andree, additional, Jarzab, Barbara, additional, Qin, Shukui, additional, Kane, Madeleine A., additional, Wirth, Lori J., additional, Chen, Connie, additional, Kim, Sinil, additional, Ingrosso, Antonella, additional, Pithavala, Yazdi K., additional, Bycott, Paul, additional, and Cohen, Ezra E. W., additional

Published
2014
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13. Recommendations for including multiple symptoms as endpoints in cancer clinical trials

Author

Cleeland, Charles S., primary, Sloan, Jeff A., additional, Cella, David, additional, Chen, Connie, additional, Dueck, Amylou C., additional, Janjan, Nora A., additional, Liepa, Astra M., additional, Mallick, Rajiv, additional, O'Mara, Ann, additional, Pearson, Jay D., additional, Torigoe, Yasuhiro, additional, Wang, Xin Shelley, additional, Williams, Loretta A., additional, and Woodruff, Jeanie F., additional

Published
2012
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17. The crystal structure of a bacterial Sufu-like protein defines a novel group of bacterial proteins that are similar to the N-terminal domain of human Sufu

Author

Das, Debanu, primary, Finn, Robert D., additional, Abdubek, Polat, additional, Astakhova, Tamara, additional, Axelrod, Herbert L., additional, Bakolitsa, Constantina, additional, Cai, Xiaohui, additional, Carlton, Dennis, additional, Chen, Connie, additional, Chiu, Hsiu-Ju, additional, Chiu, Michelle, additional, Clayton, Thomas, additional, Deller, Marc C., additional, Duan, Lian, additional, Ellrott, Kyle, additional, Farr, Carol L., additional, Feuerhelm, Julie, additional, Grant, Joanna C., additional, Grzechnik, Anna, additional, Han, Gye Won, additional, Jaroszewski, Lukasz, additional, Jin, Kevin K., additional, Klock, Heath E., additional, Knuth, Mark W., additional, Kozbial, Piotr, additional, Sri Krishna, S., additional, Kumar, Abhinav, additional, Lam, Winnie W., additional, Marciano, David, additional, Miller, Mitchell D., additional, Morse, Andrew T., additional, Nigoghossian, Edward, additional, Nopakun, Amanda, additional, Okach, Linda, additional, Puckett, Christina, additional, Reyes, Ron, additional, Tien, Henry J., additional, Trame, Christine B., additional, Bedem, Henry van den, additional, Weekes, Dana, additional, Wooten, Tiffany, additional, Xu, Qingping, additional, Yeh, Andrew, additional, Zhou, Jiadong, additional, Hodgson, Keith O., additional, Wooley, John, additional, Elsliger, Marc-André, additional, Deacon, Ashley M., additional, Godzik, Adam, additional, Lesley, Scott A., additional, and Wilson, Ian A., additional

Published
2010
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21. Crystal structure of a novel Sm-like protein of putative cyanophage origin at 2.60 Å resolution

Author

Das, Debanu, primary, Kozbial, Piotr, additional, Axelrod, Herbert L., additional, Miller, Mitchell D., additional, McMullan, Daniel, additional, Krishna, S. Sri, additional, Abdubek, Polat, additional, Acosta, Claire, additional, Astakhova, Tamara, additional, Burra, Prasad, additional, Carlton, Dennis, additional, Chen, Connie, additional, Chiu, Hsiu-Ju, additional, Clayton, Thomas, additional, Deller, Marc C., additional, Duan, Lian, additional, Elias, Ylva, additional, Elsliger, Marc-André, additional, Ernst, Dustin, additional, Farr, Carol, additional, Feuerhelm, Julie, additional, Grzechnik, Anna, additional, Grzechnik, Slawomir K., additional, Hale, Joanna, additional, Han, Gye Won, additional, Jaroszewski, Lukasz, additional, Jin, Kevin K., additional, Johnson, Hope A., additional, Klock, Heath E., additional, Knuth, Mark W., additional, Kumar, Abhinav, additional, Marciano, David, additional, Morse, Andrew T., additional, Murphy, Kevin D., additional, Nigoghossian, Edward, additional, Nopakun, Amanda, additional, Okach, Linda, additional, Oommachen, Silvya, additional, Paulsen, Jessica, additional, Puckett, Christina, additional, Reyes, Ron, additional, Rife, Christopher L., additional, Sefcovic, Natasha, additional, Sudek, Sebastian, additional, Tien, Henry, additional, Trame, Christine, additional, Trout, Christina V., additional, van den Bedem, Henry, additional, Weekes, Dana, additional, White, Aprilfawn, additional, Xu, Qingping, additional, Hodgson, Keith O., additional, Wooley, John, additional, Deacon, Ashley M., additional, Godzik, Adam, additional, Lesley, Scott A., additional, and Wilson, Ian A., additional

Published
2008
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24. Impact of the Nationwide Intravenous Selenium Product Shortage on the Development of Selenium Deficiency in Infants Dependent on Long-Term Parenteral Nutrition.

Author

Chen CH, Harris MB, Partipilo ML, Welch KB, Teitelbaum DH, and Blackmer AB

Subjects
Female, Humans, Infant, Infant Nutritional Physiological Phenomena, Infant, Newborn, Male, Parenteral Nutrition Solutions economics, Retrospective Studies, Selenium administration & dosage, Selenium blood, Parenteral Nutrition Solutions chemistry, Parenteral Nutrition Solutions supply & distribution, Selenium deficiency
Abstract

Background: For patients dependent on parenteral nutrition (PN), selenium must be supplemented intravenously. A nationwide intravenous selenium shortage began in April 2011. The impact of this shortage on PN-dependent infants was evaluated by examining the provision of selenium, development of biochemical deficiency, and costs associated with the shortage., Materials and Methods: This single-center, retrospective study included PN-dependent infants aged ≤1 year who weighed ≤30 kg, received PN for ≥1 month, and had ≥1 serum selenium measurement. The primary outcome was the incidence of biochemical selenium deficiency. Secondary outcomes included severity of biochemical deficiency, clinical manifestations, costs, and relationship between serum selenium levels and selenium dose., Results: The average selenium dose decreased 2-fold during the shortage (2.1 ± 1.2 µg/kg/d; range, 0.2-4.6 µg/kg/d) versus the nonshortage period (3.8 ± 1 µg/kg/d; range, 2.4-6 µg/kg/d; P < .001). A linear relationship between serum selenium concentration and selenium dose was observed (r(2) = 0.42), with a dose of 6 µg/kg/d expected to result in normal serum levels in most cases. Similar proportions of patients developed biochemical deficiency in both groups: shortage period, 59.1%; nonshortage, 66.7%; P = .13. The severity of biochemical deficiency was similar between groups. A significant increase in incremental cost during the shortage was observed., Conclusion: This is the first study examining the impact of the intravenous selenium shortage on PN-dependent infants. Both groups exhibited similarly high incidences of biochemical selenium deficiency, suggesting higher empiric doses may benefit this population. However, ongoing shortages limit the ability to provide supplementation., (© 2015 American Society for Parenteral and Enteral Nutrition.)

Published
2016
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25. Recommendations for including multiple symptoms as endpoints in cancer clinical trials: a report from the ASCPRO (Assessing the Symptoms of Cancer Using Patient-Reported Outcomes) Multisymptom Task Force.

Author

Cleeland CS, Sloan JA, Cella D, Chen C, Dueck AC, Janjan NA, Liepa AM, Mallick R, O'Mara A, Pearson JD, Torigoe Y, Wang XS, Williams LA, and Woodruff JF

Subjects
Humans, Neoplasms diagnosis, Severity of Illness Index, Treatment Outcome, Clinical Trials as Topic methods, Neoplasms drug therapy, Outcome Assessment, Health Care methods
Abstract

The multiple symptoms arising from cancer and its treatment impose significant distress for patients. However, in clinical research, there is no agreed-upon way of assessing and presenting the effects of treatment on multiple symptoms, as either individual scores or a composite score. The ASCPRO (Assessing the Symptoms of Cancer Using Patient-Reported Outcomes) Multisymptom Task Force was established to make recommendations about measuring multiple symptoms as outcomes in cancer clinical trials. The Multisymptom Task Force addressed how to choose the symptoms to be assessed and how multiple individual symptom scores or composite scores of several symptoms might be used as clinical trial outcomes. Consensus was reached on a definition of a multisymptom outcome, the problem of source attribution, and the need for a hypothesis-driven conceptual framework to measure multisymptom outcomes. Validated single-item and multi-item measures currently available or that can be easily generated for oncology use were deemed sufficient for measuring multiple symptoms. The relative value of a composite score versus a set of individual symptom scores was discussed, along with issues in developing and deploying such a composite measure. The results indicated that more research on combining scores of different symptoms is needed. Symptom data should be a required component of cancer clinical trials. Patient-reported symptoms provide a unique patient perspective on treatment benefit and risk that goes beyond clinician-reported adverse events. A representation of changes in multiple symptoms would clarify the impact of treatment and enhance the interpretation of cancer clinical trials for clinicians, patients, and those who make health care policy., (Copyright © 2012 American Cancer Society.)

Published
2013
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26. General population norms for the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI).

Author

Butt Z, Peipert J, Webster K, Chen C, and Cella D

Subjects
Adolescent, Adult, Aged, Carcinoma, Renal Cell pathology, Carcinoma, Renal Cell therapy, Comparative Effectiveness Research, Female, Humans, Kidney Neoplasms pathology, Kidney Neoplasms therapy, Male, Middle Aged, Quality of Life, Reference Values, Young Adult, Severity of Illness Index, Surveys and Questionnaires
Abstract

Background: Metastatic renal cell cancer is associated with poor long-term survival and has no cure. Traditional clinical endpoints are best supplemented by patient-reported outcomes designed to assess symptoms and function. Normative data was obtained on the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Kidney Symptom Index (NFKSI) to aid in score interpretation and planning of future trials., Methods: General population data were obtained from 2000 respondents, who completed the 19-item NFKSI-19, as well the SF-36 (Short Form 36-item instrument) and the PROMIS-29 (29-item Patient Reported Outcomes Measurement Information System), both general health status measures. Basic demographic and self-reported comorbidity data were also collected., Results: The sample was 50% female, 85.7% caucasian, with an equal distribution across age bands from 18 years to 75 years and older. Most respondents (62.8%) had more than a high school education and reported an Eastern Cooperative Oncology Group performance status of normal activity without symptoms (63.4%). Score distributions on the NFKSI-19, its subscales, and individual items are summarized., Conclusions: The NFKSI-19 and its subscales now have scores for the general US population, allowing comparability to generic questionnaires such as the SF-36 and PROMIS-29. These data can be used to guide treatment expectations and plan future comparative effectiveness research using the scales., (Copyright © 2012 American Cancer Society.)

Published
2013
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27. Large-scale stopping and switching treatment with COX-2 inhibitors after the rofecoxib withdrawal.

Author

Sukel MP, van der Linden MW, Chen C, Erkens JA, and Herings RM

Subjects
Anti-Inflammatory Agents, Non-Steroidal adverse effects, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Arthritis, Rheumatoid drug therapy, Cardiovascular Diseases prevention & control, Cohort Studies, Cyclooxygenase 2 Inhibitors adverse effects, Databases, Factual, Drug Prescriptions statistics & numerical data, Drug Therapy, Combination, Drug and Narcotic Control, Female, Gastrointestinal Diseases chemically induced, Gastrointestinal Diseases prevention & control, Humans, Lactones adverse effects, Male, Middle Aged, Proton Pump Inhibitors, Sulfones adverse effects, Cyclooxygenase 2 Inhibitors administration & dosage, Drug Utilization Review, Lactones administration & dosage, Practice Patterns, Physicians' statistics & numerical data, Sulfones administration & dosage
Abstract

Purpose: To compare treatment changes after the rofecoxib withdrawal with changes occurring normally and to re-assess 12 months afterwards., Methods: The PHARMO database comprised medication and hospital discharge records of over 3 million inhabitants in the Netherlands. The Study cohort included chronic coxib users with a coxib prescription on 30th September 2004; the Reference cohort others with a coxib prescription on 1st June 2004. Initial treatment changes were based on first new prescription since cohort entry. Twelve-month changes were studied within the Study cohort only., Results: The Study cohort (n = 6974) and Reference cohort (n = 5393) had similar demographics, stratified on type of coxib. In the Study cohort, 3341 (48%) initially stopped coxibs, of whom 1121 (16%) stopped all analgesic, versus 13 and 5% in the Reference cohort (p < 0.001). Among 'other coxib' users 32% stopped coxibs, and 15% stopped all analgesics, versus 14% and 4%, p < 0.001 in the Reference cohort. Among those who stopped coxibs, 34% switched to non-selective non-steroidal anti-inflammatory drug (nsNSAID) without PPI, 21% to nsNSAID with PPI, and 45% stopped NSAID treatment (Reference cohort: 35, 20, and 44%, respectively). These rates for 'other coxib users' were: switching to nsNSAID without PPI 23% (Study Cohort) versus 35% (Reference Cohort), 13 versus 28%, and 64 versus 37% respectively (p < 0.001). Twelve months later, stopping NSAID increased to 43%, stopping all analgesics to 32%. Rheumatologists continued coxibs more frequently than other caregivers (87, 65, 54%, respectively)., Conclusions: The rofecoxib withdrawal resulted in a large proportion of patients who discontinued analgesic treatment altogether regardless of original coxib therapy.

Published
2008
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