Search Results - "Chen, Yeh‐Fong"

Challenges and potential strategies utilizing external data for efficacy evaluation in small-sized clinical trials by Jiao, Feiran, Chen, Yeh-Fong, Min, Min, Jimenez, Sara

“…In clinical trials for diseases with very small patient populations, trial investigators may encounter recruitment difficulties. It can be challenging to…”
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FDA Drug Approval Summary: Erlotinib (Tarceva®) Tablets by Cohen, Martin H., Johnson, John R., Chen, Yeh‐Fong, Sridhara, Rajeshwari, Pazdur, Richard

“…On November 18, 2004, erlotinib (Tarceva®; OSI Pharmaceuticals, Inc., Melville, NY, http://www.osip.com, and Genentech, Inc., South San Francisco, CA,…”
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Utilizing shared internal control arms and historical information in small-sized platform clinical trials by Jiao, Feiran, Tu, Wenda, Jimenez, Sara, Crentsil, Victor, Chen, Yeh-Fong

“…Recruitment of patients in concurrent control arms can be very challenging for clinical trials for pediatric and rare diseases. Innovative approaches, such as…”
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Incorporating Prior Data in Quantitative Benefit-Risk Assessments: Case Study of a Bayesian Method by Dharmarajan, Sai, Yuan, Zhong, Chen, Yeh-Fong, Lackey, Leila, Mukhopadhyay, Saurabh, Singh, Pritibha, Tiwari, Ram

“…Multiple criteria decision analysis (MCDA) and stochastic multi-criteria acceptability analysis (SMAA) in their current implementation cannot incorporate prior…”
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Clinical endpoints and adaptive clinical trials in precirrhotic nonalcoholic steatohepatitis: Facilitating development approaches for an emerging epidemic by Filozof, Claudia, Chow, Shein‐Chung, Dimick‐Santos, Lara, Chen, Yeh‐Fong, Williams, Richard N., Goldstein, Barry J., Sanyal, Arun

“…Due to the increasing prevalence of nonalcoholic steatohepatitis (NASH) and its associated health burden, there is a high need to develop therapeutic…”
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Unified additional requirement in consideration of regional approval for multiregional clinical trials by Teng, Zhaoyang, Chen, Yeh-Fong, Chang, Mark

“…To speed up the process of bringing a new drug to the market, more and more clinical trials are being conducted simultaneously in multiple regions. After…”
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The plan of enrichment designs for dealing with high placebo response by Zhang, Xiangmin, Chen, Yeh‐Fong, Tamura, Roy

“…To deal with high placebo response in clinical trials for psychiatric and other diseases, different enrichment designs, such as the sequential parallel design,…”
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A sequential enriched design for target patient population in psychiatric clinical trials by Chen, Yeh-Fong, Zhang, Xiangmin, Tamura, Roy N., Chen, Chiung M.

“…High placebo response is widely believed to be one major reason why many psychiatric clinical trials fail to demonstrate drug efficacy. In order to alleviate…”
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Approval Summary for Erlotinib for Treatment of Patients with Locally Advanced or Metastatic Non–Small Cell Lung Cancer after Failure of at Least One Prior Chemotherapy Regimen by JOHNSON, John R, COHEN, Martin, LI SHAN HSIEH, CHIDAMBARAM, Nallalerumal, ZIMMERMAN, Paul, PAZDUR, Richard, SRIDHARA, Rajeshwari, CHEN, Yeh-Fong, WILLIAMS, Gene M, DUAN, John, GOBBURU, Jogarao, BOOTH, Brian, BENSON, Kimberly, LEIGHTON, John

“…Purpose: To describe the Food and Drug Administration (FDA) review and approval of erlotinib (Tarceva, OSI Pharmaceuticals, Melville, NY) for treatment of…”
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Testing treatment effect in schizophrenia clinical trials with heavy patient dropout using latent class growth mixture models by Kong, Fanhui, Chen, Yeh-Fong

“…By examining the outcome trajectories of the dropout patients with different reasons in the schizophrenia trials, we note that although patients are recruited…”
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Trial design issues and treatment effect modeling in multi-regional schizophrenia trials by Chen, Yeh-Fong, Wang, Sue-Jane, Khin, Ni A., Hung, H. M. James, Laughren, Thomas P.

“…In recent years, we have seen an increasing trend of foreign data as part of clinical trial data submitted in new drug applications (NDA) to US Food and Drug…”
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Consideration of the adaptive randomization allocation ratio in the presence of treatment group heteroscedasticity in clinical trials by Lu, Jiashen, Chen, Yeh-Fong

“…For randomized clinical trials, subjects' variance structures may vary over time among treatment groups, resulting in the heteroscedasticity of residuals in a…”
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Exploratory Analyses of Efficacy Data From Major Depressive Disorder Trials Submitted to the US Food and Drug Administration in Support of New Drug Applications by KHIN, Ni A, CHEN, Yeh-Fong, YANG YANG, PEILING YANG, LAUGHREN, Thomas P

“…There has been concern about a high rate of placebo response and a substantial failure rate in recent clinical trials in major depressive disorder (MDD). This…”
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Review of maintenance trials for major depressive disorder: a 25-year perspective from the US Food and Drug Administration by Borges, Silvana, Chen, Yeh-Fong, Laughren, Thomas P, Temple, Robert, Patel, Hiren D, David, Paul A, Mathis, Mitchell, Unger, Ellis, Yang, Peiling, Khin, Ni A

“…The maintenance efficacy of antidepressants is usually assessed in postmarketing studies with a randomized withdrawal design. This report explores differences…”
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Exploratory Analyses of Efficacy Data From Schizophrenia Trials in Support of New Drug Applications Submitted to the US Food and Drug Administration by KHIN, Ni A, CHEN, Yeh-Fong, YANG YANG, PEILING YANG, LAUGHREN, Thomas P

“…There has been concern about a high rate of placebo response and a decline in treatment effect over time in schizophrenia trials as well as the implications of…”
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A small n sequential multiple assignment randomized trial design for use in rare disease research by Tamura, Roy N, Krischer, Jeffrey P, Pagnoux, Christian, Micheletti, Robert, Grayson, Peter C, Chen, Yeh-Fong, Merkel, Peter A

“…Abstract Background Clinical trials in rare diseases are difficult to conduct due to the limited number of patients available with each disorder. We developed…”
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Evaluation of performance of some enrichment designs dealing with high placebo response in psychiatric clinical trials by Chen, Yeh-Fong, Yang, Yang, Hung, H.M. James, Wang, Sue-Jane

“…Abstract Dealing with high placebo response remains a big challenge to conventional clinical trials for psychiatric disorders. A widely-used design strategy is…”
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Dr Khin and Colleagues Reply by Khin, Ni A., Chen, Yeh-Fong, Yang, Yang, Yang, Peiling, Laughren, Thomas P.

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A Bias Correction in Testing Treatment Efficacy Under Informative Dropout in Clinical Trials by Kong, Fanhui, Chen, Yeh-Fong, Jin, Kun

“…In clinical trials of drug development, patients are often followed for a certain period of time, and the outcome variables are measured at scheduled time…”
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The distribution of sizes of ordered level sets by Dykstra, Richard, Chen, Yeh-Fong

“…The level sets obtained from an equal weights isotonic regression are often of interest. Here we derive the joint distribution of the sizes of the level sets…”
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