Search Results - "Sverdlov, Oleksandr"

Digital Therapeutics: An Integral Component of Digital Innovation in Drug Development by Sverdlov, Oleksandr, van Dam, Joris, Hannesdottir, Kristin, Thornton‐Wells, Tricia

“…Digital therapeutics represent a new treatment modality in which digital systems such as smartphone apps are used as regulatory‐approved, prescribed…”
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Forced randomization: the what, why, and how by Carter, Kerstine, Kuznetsova, Olga, Anisimov, Volodymyr, Krisam, Johannes, Scherer, Colin, Ryeznik, Yevgen, Sverdlov, Oleksandr

“…When running a randomized controlled trial (RCT), a clinical site may face a situation when an eligible trial participant is to be randomized to the treatment…”
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Accounting for Patient Engagement in Randomized Controlled Trials Evaluating Digital Cognitive Behavioral Therapies by Sverdlov, Oleksandr, Ryeznik, Yevgen

“…Background: Cognitive behavioral therapy (CBT) can be a useful treatment option for various mental health disorders. Modern advances in information technology…”
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A roadmap to using randomization in clinical trials by Berger, Vance W, Bour, Louis Joseph, Carter, Kerstine, Chipman, Jonathan J, Everett, Colin C, Heussen, Nicole, Hewitt, Catherine, Hilgers, Ralf-Dieter, Luo, Yuqun Abigail, Renteria, Jone, Ryeznik, Yevgen, Sverdlov, Oleksandr, Uschner, Diane

“…Randomization is the foundation of any clinical trial involving treatment comparison. It helps mitigate selection bias, promotes similarity of treatment groups…”
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Selecting a randomization method for a multi-center clinical trial with stochastic recruitment considerations by Sverdlov, Oleksandr, Ryeznik, Yevgen, Anisimov, Volodymyr, Kuznetsova, Olga M, Knight, Ruth, Carter, Kerstine, Drescher, Sonja, Zhao, Wenle

“…The design of a multi-center randomized controlled trial (RCT) involves multiple considerations, such as the choice of the sample size, the number of centers…”
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A Smartphone-Based Intervention as an Adjunct to Standard-of-Care Treatment for Schizophrenia: Randomized Controlled Trial by Ghaemi, S Nassir, Sverdlov, Oleksandr, van Dam, Joris, Campellone, Timothy, Gerwien, Robert

“…Antipsychotic medications have limited benefits in schizophrenia, and cognitive behavioral therapy may be beneficial as an adjunct. There may be potential for…”
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RARtool: A MATLAB Software Package for Designing Response-Adaptive Randomized Clinical Trials with Time-to-Event Outcomes by Ryeznik, Yevgen, Sverdlov, Oleksandr, Wong, Weng Kee

“…Response-adaptive randomization designs are becoming increasingly popular in clinical trial practice. In this paper, we present , a user interface software…”
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Decentralized Clinical Trials: Scientific Considerations Through the Lens of the Estimand Framework by Izem, Rima, Zuber, Emmanuel, Daizadeh, Nadia, Bretz, Frank, Sverdlov, Oleksandr, Edrich, Pascal, Branson, Janice, Degtyarev, Evgeny, Sfikas, Nikolaos, Hemmings, Robert

“…While industry and regulators' interest in decentralized clinical trials (DCTs) is long-standing, the Covid-19 pandemic accelerated and broadened the adoption…”
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Pharmacometrics meets statistics—A synergy for modern drug development by Ryeznik, Yevgen, Sverdlov, Oleksandr, Svensson, Elin M., Montepiedra, Grace, Hooker, Andrew C., Wong, Weng Kee

“…Modern drug development problems are very complex and require integration of various scientific fields. Traditionally, statistical methods have been the…”
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Investigating the value of glucodensity analysis of continuous glucose monitoring data in type 1 diabetes: an exploratory analysis by Cui, Elvis Han, Goldfine, Allison B., Quinlan, Michelle, James, David A., Sverdlov, Oleksandr

“…Introduction Continuous glucose monitoring (CGM) devices capture longitudinal data on interstitial glucose levels and are increasingly used to show the…”
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A Study of Novel Exploratory Tools, Digital Technologies, and Central Nervous System Biomarkers to Characterize Unipolar Depression by Sverdlov, Oleksandr, Curcic, Jelena, Hannesdottir, Kristin, Gou, Liangke, De Luca, Valeria, Ambrosetti, Francesco, Zhang, Bingsong, Praestgaard, Jens, Vallejo, Vanessa, Dolman, Andrew, Gomez-Mancilla, Baltazar, Biliouris, Konstantinos, Deurinck, Mark, Cormack, Francesca, Anderson, John J., Bott, Nicholas T., Peremen, Ziv, Issachar, Gil, Laufer, Offir, Joachim, Dale, Jagesar, Raj R., Jongs, Niels, Kas, Martien J., Zhuparris, Ahnjili, Zuiker, Rob, Recourt, Kasper, Zuilhof, Zoë, Cha, Jang-Ho, Jacobs, Gabriel E.

“…Background: Digital technologies have the potential to provide objective and precise tools to detect depression-related symptoms. Deployment of digital…”
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MIJ821 (onfasprodil) in healthy volunteers: First-in-human, randomized, placebo-controlled study (single ascending dose and repeated intravenous dose) by Gomez-Mancilla, Baltazar, Levy, Jeffrey A, Ganesan, Subramanian, Faller, Thomas, Issachar, Gil, Peremen, Ziv, Laufer, Offir, Shani-Hershkovich, Revital, Biliouris, Kostas, Walker, Ela, Healy, Mark P, Sverdlov, Oleksandr, Desai, Sachin, Ghaemi, S Nassir, Cha, Jang-Ho, Shanker, Y Gopi

“…This single-center study administered MIJ821 (onfasprodil) as an intravenous infusion to healthy volunteers and included two parts: a single ascending dose…”
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Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study of the Oral γ-Secretase Inhibitor BMS-708163 (Avagacestat): Tolerability Profile, Pharmacokinetic Parameters, and Pharmacodynamic Markers by Tong, Gary, MD, PhD, Wang, Jun-Sheng, PhD, Sverdlov, Oleksandr, PhD, Huang, Shu-Pang, PhD, Slemmon, Randy, PhD, Croop, Robert, MD, Castaneda, Lorna, MS, Gu, Huidong, MS, Wong, Oi, BS, Li, Hewei, MD, PhD, Berman, Robert M., MD, Smith, Christina, DPhil, Albright, Charles F., PhD, Dockens, Randy C., PhD

“…Abstract Background γ-Secretase inhibitors (GSIs) are being investigated for their potential to modify the progression of Alzheimer disease based on their…”
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Description of the Method for Evaluating Digital Endpoints in Alzheimer Disease Study: Protocol for an Exploratory, Cross-sectional Study by Curcic, Jelena, Vallejo, Vanessa, Sorinas, Jennifer, Sverdlov, Oleksandr, Praestgaard, Jens, Piksa, Mateusz, Deurinck, Mark, Erdemli, Gul, Bügler, Maximilian, Tarnanas, Ioannis, Taptiklis, Nick, Cormack, Francesca, Anker, Rebekka, Massé, Fabien, Souillard-Mandar, William, Intrator, Nathan, Molcho, Lior, Madero, Erica, Bott, Nicholas, Chambers, Mieko, Tamory, Josef, Shulz, Matias, Fernandez, Gerardo, Simpson, William, Robin, Jessica, Snædal, Jón G, Cha, Jang-Ho, Hannesdottir, Kristin

“…More sensitive and less burdensome efficacy end points are urgently needed to improve the effectiveness of clinical drug development for Alzheimer disease…”
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Implementing unequal randomization in clinical trials with heterogeneous treatment costs by Sverdlov, Oleksandr, Ryeznik, Yevgen

“…Equal randomization has been a popular choice in clinical trial practice. However, in trials with heterogeneous variances and/or variable treatment costs, as…”
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A comparative study of restricted randomization procedures for multiarm trials with equal or unequal treatment allocation ratios by Ryeznik, Yevgen, Sverdlov, Oleksandr

“…Randomization designs for multiarm clinical trials are increasingly used in practice, especially in phase II dose‐ranging studies. Many new methods have been…”
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Understanding an impact of patient enrollment pattern on predictability of central (unstratified) randomization in a multi‐center clinical trial by Krisam, Johannes, Ryeznik, Yevgen, Carter, Kerstine, Kuznetsova, Olga, Sverdlov, Oleksandr

“…In a multi‐center randomized controlled trial (RCT) with competitive recruitment, eligible patients are enrolled sequentially by different study centers and…”
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Sample size determination for the association between longitudinal and time‐to‐event outcomes using the joint modeling time‐dependent slopes parameterization by LeClair, Jessica, Massaro, Joseph, Sverdlov, Oleksandr, Gordon, Leslie, Tripodis, Yorghos

“…Given their improvements in bias reduction and efficiency, joint models (JMs) for longitudinal and time‐to‐event data offer great potential to clinical trials…”
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Clinical Design and Analysis Strategies for the Development of Gene Therapies: Considerations for Quantitative Drug Development in the Age of Genetic Medicine by McIntosh, Avery, Sverdlov, Oleksandr, Yu, Li, Kaufmann, Petra

“…Cell and gene therapies have shown enormous promise across a range of diseases in recent years. Numerous adoptive cell therapy modalities as well as systemic…”
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Opportunity for efficiency in clinical development: An overview of adaptive clinical trial designs and innovative machine learning tools, with examples from the cardiovascular field by Sverdlov, Oleksandr, Ryeznik, Yevgen, Wong, Weng Kee

“…Modern data analysis tools and statistical modeling techniques are increasingly used in clinical research to improve diagnosis, estimate disease progression…”
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