Academic literature on the topic 'Clinical Trial Randomization'
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Journal articles on the topic "Clinical Trial Randomization"
Harvin, John A., Ben L. Zarzaur, Raminder Nirula, Benjamin T. King, and Ajai K. Malhotra. "Alternative clinical trial designs." Trauma Surgery & Acute Care Open 5, no. 1 (February 2020): e000420. http://dx.doi.org/10.1136/tsaco-2019-000420.
Full textBaghbaninaghadehi, Fatemeh. "Fundamentals of Randomization in Clinical Trial." International Journal of Advanced Nutritional and Health Science 4, no. 1 (2016): 174–87. http://dx.doi.org/10.23953/cloud.ijanhs.143.
Full textDeserno, Thomas M., and András P. Keszei. "Mobile access to virtual randomization for investigator-initiated trials." Clinical Trials 14, no. 4 (April 28, 2017): 396–405. http://dx.doi.org/10.1177/1740774517706509.
Full textSupawattan, Busaba, and Lily Ingsrisawa. "Bayesian Adaptive Randomization Designs for Clinical Trial." Journal of Applied Sciences 15, no. 2 (January 15, 2015): 374–76. http://dx.doi.org/10.3923/jas.2015.374.376.
Full textMichael, Nelson L. "Clinical trial design: The nobility of randomization." Science Translational Medicine 9, no. 419 (December 6, 2017): eaaq0810. http://dx.doi.org/10.1126/scitranslmed.aaq0810.
Full textTiwari, Jawahar, and Cornelius J. Lynch. "81P Tightening the clinical trial by randomization." Controlled Clinical Trials 15, no. 3 (June 1994): 122–23. http://dx.doi.org/10.1016/0197-2456(94)90209-7.
Full textGrant, William C. "Run-Reversal Equilibrium for Clinical Trial Randomization." PLOS ONE 10, no. 6 (June 16, 2015): e0128812. http://dx.doi.org/10.1371/journal.pone.0128812.
Full textHilgers, Ralf-Dieter, Martin Manolov, Nicole Heussen, and William F. Rosenberger. "Design and analysis of stratified clinical trials in the presence of bias." Statistical Methods in Medical Research 29, no. 6 (May 10, 2019): 1715–27. http://dx.doi.org/10.1177/0962280219846146.
Full textSidani, Souraya, Mary Fox, and Laura Collins. "Towards Patient-Centered Clinical Trial Designs." European Journal for Person Centered Healthcare 5, no. 3 (September 26, 2017): 300. http://dx.doi.org/10.5750/ejpch.v5i3.1308.
Full textCellamare, Matteo, Steffen Ventz, Elisabeth Baudin, Carole D. Mitnick, and Lorenzo Trippa. "A Bayesian response-adaptive trial in tuberculosis: The endTB trial." Clinical Trials 14, no. 1 (September 23, 2016): 17–28. http://dx.doi.org/10.1177/1740774516665090.
Full textDissertations / Theses on the topic "Clinical Trial Randomization"
Batidzirai, Jesca Mercy. "Randomization in a two armed clinical trial: an overview of different randomization techniques." Thesis, University of Fort Hare, 2011. http://hdl.handle.net/10353/395.
Full textWang, Hui. "Response Adaptive Randomization using Surrogate and Primary Endpoints." VCU Scholars Compass, 2016. http://scholarscompass.vcu.edu/etd/4517.
Full textDi, Pace Brian S. "Site- and Location-Adjusted Approaches to Adaptive Allocation Clinical Trial Designs." VCU Scholars Compass, 2019. https://scholarscompass.vcu.edu/etd/5706.
Full textLunceford, Jared Kenneth. "ESTIMATING CAUSAL TREATMENT EFFECTS VIA THE PROPENSITY SCORE AND ESTIMATING SURVIVAL DISTRIBUTIONS IN CLINICAL TRIALS THAT FOLLOW TWO-STAGE RANDOMIZATION DESIGNS." NCSU, 2001. http://www.lib.ncsu.edu/theses/available/etd-20010803-202112.
Full textLUNCEFORD, JARED KENNETH. Estimating Causal Treatment Effects Via thePropensity Score and Estimating Survival Distributions in Clinical TrialsThat Follow Two-stage Randomization Designs. (Under the direction ofProfessor Marie Davidian)Estimation of treatment effects with causalinterpretation from obervational data is complicated by the fact thatexposure to treatment is confounded with subject characteristics. Thepropensity score, the probability of exposure to treatment conditionalon covariates, is the basis for two competing classes of approachesfor adjusting for confounding: methods based on stratification ofobservations by quantiles of estimated propensity scores, and methodsbased on weighting individual observations by weights depending onestimated propensity scores. We review these approaches andinvestigate their relative performance.Some clinical trials follow a design in which patientsare randomized to a primary therapy upon entry followed by anotherrandomization to maintenance therapy contingent upon diseaseremission. Ideally, analysis would allow different treatmentpolicies, i.e. combinations of primary and maintenance therapy ifspecified up-front, to be compared. Standard practice is to conductseparate analyses for the primary and follow-up treatments, which doesnot address this issue directly. We propose consistent estimators ofthe survival distribution and mean survival time for each treatmentpolicy in such two-stage studies and derive large sampleproperties. The methods are demonstrated on a leukemia clinical trialdata set and through simulation.
Souley, Issoufou Mamane Sani. "Anthropologie d'un essai clinique : enjeux de santé globale autour d'un nouveau vaccin testé par un complexe humanitaro-scientifique." Thesis, Lyon, 2020. http://www.theses.fr/2020LYSEN035.
Full textIn 2015, Epicentre, an epidemiological research center created in 1987 by the humanitarian NGO Médecins Sans Frontières (MSF), will begin a randomised clinical trial of a new vaccine against severe forms of diarrhoea in children under five years of age. It is produced by the Serum Institute Of lndia Limited (an Indian pharmaceutical company). The trial is being conducted in Madarounfa, a rural community in southem Niger. This thesis proposes to discuss the global dimensions and local issues surrounding a vaccine, Rotasiil which can be defined as "an African vaccine" if on considers the way it is presented and promoted by the Serwn Institute, MSF, and Epicentre. The Rotasiil vaccine trial is testament to the utopia of global health actors that technology and the omnipotence of medicine can defeat disease b obscuring the context of structural violence in which their intervention takes place (Farmer 2002; Farmer 2002; Galtun · and Hôivik 1971). It also testifies to the emergence of new actors (NGOs and industries) in the field of global healt policies (Bertho-Huidal 2012). This thesis is also interested in the science "in the making" and analyses the social conditions of sample collection, from their analysis in the laboratory to the entry of the results in a database. It ais describes the adjustrnents and negotiations at work in the application of the "gold standard" of clinical trials that are confronted with the interactional context of their implementation (Brives, Le Marcis, and Sanabria 2016)
Han, Baoguang. "Statistical analysis of clinical trial data using Monte Carlo methods." Thesis, 2014. http://hdl.handle.net/1805/4650.
Full textIn medical research, data analysis often requires complex statistical methods where no closed-form solutions are available. Under such circumstances, Monte Carlo (MC) methods have found many applications. In this dissertation, we proposed several novel statistical models where MC methods are utilized. For the first part, we focused on semicompeting risks data in which a non-terminal event was subject to dependent censoring by a terminal event. Based on an illness-death multistate survival model, we proposed flexible random effects models. Further, we extended our model to the setting of joint modeling where both semicompeting risks data and repeated marker data are simultaneously analyzed. Since the proposed methods involve high-dimensional integrations, Bayesian Monte Carlo Markov Chain (MCMC) methods were utilized for estimation. The use of Bayesian methods also facilitates the prediction of individual patient outcomes. The proposed methods were demonstrated in both simulation and case studies. For the second part, we focused on re-randomization test, which is a nonparametric method that makes inferences solely based on the randomization procedure used in clinical trials. With this type of inference, Monte Carlo method is often used for generating null distributions on the treatment difference. However, an issue was recently discovered when subjects in a clinical trial were randomized with unbalanced treatment allocation to two treatments according to the minimization algorithm, a randomization procedure frequently used in practice. The null distribution of the re-randomization test statistics was found not to be centered at zero, which comprised power of the test. In this dissertation, we investigated the property of the re-randomization test and proposed a weighted re-randomization method to overcome this issue. The proposed method was demonstrated through extensive simulation studies.
Cerqueira, Franck Pires. "Modelos Dinâmicos de Ensaios Clínicos: Desenho Adaptativo." Master's thesis, 2018. http://hdl.handle.net/10316/84533.
Full textApesar da despesa em I & D na indústria farmacêutica ter tido nas últimas décadas um crescimento sustentado, o número de produtos medicinais colocados em desenvolvimento clínico até à autorização de comercialização não tem aumentado na mesma proporção. Um número pequeno mas crescente de ensaios clínicos usa um desenho de estudos clínicos chamado Desenho Adaptativo que permite aos investigadores responderem aos dados recolhidos durante o estudo. Num ensaio adaptativo, o investigador pode ter a opção de responder a dados interinos de segurança e eficácia de várias formas, incluindo estreitar o foco do estudo ou aumentar o número de participantes, equilibrar a alocação ao tratamento ou ainda com diferentes formas de randomização com base na resposta de participantes anteriores ao tratamento. De forma a inverter este impasse na investigação clínica e a incrementar a competitividade económica e a segurança para os participantes nos ensaios clínicos, este trabalho visa o levantamento das guidelines internacionais (FDA, EMA) para a aplicação e condução de ensaios através de desenho adaptativo, bem como a recolha de artigos referentes diversos ensaios conduzidos em vários países de modo a importar essas experiências para a realidade da investigação clínica nacional.Desta análise é possível inferir que o uso de Desenho Adaptativo constitui uma vantagem ética e científica quando adequadamente planeado e aplicado dado aumentar a flexibilidade do ensaio, encurtar o tempo global de investigação clínica de um medicamento e reduzir o risco de exposição de doentes a efeitos adversos relacionados com o medicamento experimental. Contudo, não é uma metodologia extrapolável para todas as fases de investigação clínica (maioritariamente fases exploratórias e confirmatórias) e sua maior complexidade metodológica e analítica requerem uma metodologia estatística adequada, bem como sua aplicação limitar-se a ensaios com menor número de centros de estudo, com extensões de tempo mais limitadas e a medicamentos experimentais com efeitos clínicos mais imediatos para análise interina.
Although R & D spending in the pharmaceutical industry has been growing steadily in recent decades, the number of medicinal products under clinical development up to the marketing authorization has not increased by the same proportion.A small but growing number of clinical trials use a clinical study design called Adaptive Design that allows researchers to respond to data collected during the study.In an adaptive trial, the investigator may have the option of responding to interim safety and efficacy data in a number of ways, including narrowing the study focus or increasing the number of participants, balancing treatment allocation or different forms of randomization based on responses of participants prior to treatment.In order to reverse this setback in clinical research and to increase economic competitiveness and safety for participants in clinical trials, this essay aims at raising the international guidelines (FDA, EMA) for the application and conduct of trials through adaptive design, as well as the collection of different articles referring to several trials conducted in several countries in order to import these experiences into the reality of national clinical research.From this analysis it is possible to infer that the use of Adaptive Design is an ethical and scientific advantage when properly planned and applied, since it increases the flexibility of the trial, shorten the overall clinical investigation time of a drug and reduce the risk of patient exposure to adverse effects related to the experimental drug. However, it is not an extrapolated methodology for all phases of clinical investigation (mainly exploratory and confirmatory phases). Its greater methodological and analytical complexity require an adequate statistical methodology, its application is limited to trials with smaller number of study centers with smaller extensions of time and to experimental drugs with more immediate clinical effects for their interim analysis.
Guo, Xiang. "Statistical analysis in two stage randomization designs in clinical trials." 2005. http://www.lib.ncsu.edu/theses/available/etd-06232005-143538/unrestricted/etd.pdf.
Full textTU, JUI-CHUAN, and 涂瑞銓. "Adaptive Randomization for Multiarm Survival Clinical Trials Using Short-Term Response Information." Thesis, 2019. http://ndltd.ncl.edu.tw/handle/bncgwj.
Full text東海大學
統計學系
107
We usually don’t want to waste substantial amount of time and resources in phase two clinical trials, therefore we need effective methods of randomization, so that we can chose a potential treatment on survival, and confirm its benefit in phase three trial quickly. Traditionally, using survival time as a primary endpoint, takes a long period of time to assign patients to different groups ineffectively during the adaptive-randomization trails. However, using short-term efficacy (e.g. tumor response rate) as a primary endpoint, may show that patients have good efficacy shortly, but do not have long period of survival time. Owing to prolonging survival time is a common goal of a better treatment, Huang et al. (2009) proposed a model which used short-term response information to facility adaptive randomization for survival clinical trials. In this article, we extend the method which Huang et al. (2009) proposed to multi-arms clinical trials. Moreover, we assume that the survival time of patients is following the mixture Weibull distribution. In addition, since the model of Huang et al. (2009) proposed conduct interim analyses each cohort of one patient, and following patient randomize into the trial is based on the revised probability of adaptive randomization. In order to save time, we consider to conduct interim analyses each cohort of five patients, then compare the respective simulation results.
Wahed, Abdus Shakoor Fazlul. "Efficient estimation of the survival distribution and related quantities of treatment policies in two-stage randomization designs in clinical trials." 2003. http://www.lib.ncsu.edu/theses/available/etd-08112003-164310/unrestricted/etd.pdf.
Full textBooks on the topic "Clinical Trial Randomization"
Rosenberger, William F., and John M. Lachin. Randomization in Clinical Trials. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2002. http://dx.doi.org/10.1002/0471722103.
Full textRosenberger, William F., and John M. Lachin. Randomization in Clinical Trials. Hoboken, NJ, USA: John Wiley & Sons, Inc, 2016. http://dx.doi.org/10.1002/9781118742112.
Full textRosenberger, William F. Randomization in clinical trials: Theory and practice. New York: Wiley, 2002.
Find full text1942-, Lachin John M., ed. Randomization in clinical trials: Theory and practice. Hoboken, New Jersey: John Wiley & Sons, Inc., 2016.
Find full textF, Rosenberger William, ed. The theory of response-adaptive randomization in clinical trials. Hoboken, NJ: John Wiley & Sons, 2006.
Find full textHu, Feifang, and William F. Rosenberger. The Theory of Response-Adaptive Randomization in Clinical Trials. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2006. http://dx.doi.org/10.1002/047005588x.
Full textNeil, Klar, ed. Design and analysis of cluster randomization trials in health research. London: Arnold, 2000.
Find full textHaynes, Richard, Martin J. Landray, William G. Herrington, and Colin Baigent. Clinical trials. Edited by Christopher G. Winearls. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199592548.003.0019.
Full textWiffen, Philip, Marc Mitchell, Melanie Snelling, and Nicola Stoner. Clinical trials. Oxford University Press, 2012. http://dx.doi.org/10.1093/med/9780199603640.003.0005.
Full textHershberger, Scott L. Multivariate Clinical Trials For Randomized Experiments In The Behavioral Sciences. Psychology Press, 2011.
Find full textBook chapters on the topic "Clinical Trial Randomization"
Zhang, Lanju, and William F. Rosenberger. "Response-Adaptive Randomization for Clinical Trials." In Practical Considerations for Adaptive Trial Design and Implementation, 183–99. New York, NY: Springer New York, 2014. http://dx.doi.org/10.1007/978-1-4939-1100-4_10.
Full textUnbehaun, V. "Randomization and Follow-up Care of Patients in a Breast Cancer Clinical Trial: Personal Experience." In Cancer Clinical Trials, 171–73. Berlin, Heidelberg: Springer Berlin Heidelberg, 1988. http://dx.doi.org/10.1007/978-3-642-83419-6_19.
Full textLin, Jianchang, Li-An Lin, and Serap Sankoh. "A Phase II Trial Design with Bayesian Adaptive Covariate-Adjusted Randomization." In Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics, 61–73. Cham: Springer International Publishing, 2016. http://dx.doi.org/10.1007/978-3-319-42568-9_6.
Full textPocock, Stuart J. "Methods of Randomization." In Clinical Trials, 66–89. West Sussex, England: John Wiley & Sons Ltd,., 2013. http://dx.doi.org/10.1002/9781118793916.ch5.
Full textProschan, Michael A., and Julian Barreiro-Gomez. "Randomization/Allocation." In Statistical Thinking in Clinical Trials, 65–74. Boca Raton: Chapman and Hall/CRC, 2021. http://dx.doi.org/10.1201/9781315164090-5.
Full textFriedman, Lawrence M., Curt D. Furberg, and David L. DeMets. "The Randomization Process." In Fundamentals of Clinical Trials, 97–117. New York, NY: Springer New York, 2010. http://dx.doi.org/10.1007/978-1-4419-1586-3_6.
Full textFriedman, Lawrence M., Curt D. Furberg, and David L. DeMets. "The Randomization Process." In Fundamentals of Clinical Trials, 61–81. New York, NY: Springer New York, 1998. http://dx.doi.org/10.1007/978-1-4757-2915-3_5.
Full textFriedman, Lawrence M., Curt D. Furberg, David L. DeMets, David M. Reboussin, and Christopher B. Granger. "The Randomization Process." In Fundamentals of Clinical Trials, 123–45. Cham: Springer International Publishing, 2015. http://dx.doi.org/10.1007/978-3-319-18539-2_6.
Full textProschan, Michael A., and Julian Barreiro-Gomez. "Randomization-Based Inference." In Statistical Thinking in Clinical Trials, 75–108. Boca Raton: Chapman and Hall/CRC, 2021. http://dx.doi.org/10.1201/9781315164090-6.
Full textZhang, Lanju, and William F. Rosenberger. "Adaptive Randomization in Clinical Trials." In Design and Analysis of Experiments, 251–81. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2012. http://dx.doi.org/10.1002/9781118147634.ch7.
Full textConference papers on the topic "Clinical Trial Randomization"
Cai, HongWei, YongJi Wang, and JieLai Xia. "Comparison of balance ability of minimization, simple and stratified block randomization from true data of a clinical trial." In 2011 International Symposium on Information Technology in Medicine and Education (ITME 2011). IEEE, 2011. http://dx.doi.org/10.1109/itime.2011.6132058.
Full textTiancai, Wen, Liu Baoyan, He Liyun, Lv Xiaoying, Wang Xin, and Zhang Yanning. "A randomization and trial supply management system for adaptive clinical studies of TCM and its scientific research application in recurrent tuberculosis." In 2018 IEEE International Conference on Bioinformatics and Biomedicine (BIBM). IEEE, 2018. http://dx.doi.org/10.1109/bibm.2018.8621116.
Full textPoniewierski, M., M. Barthels, and H. Poliwoda. "THE SAFETY AND EFFICACY OF A LOW MOLECULAR WEIGHT HEPARIN (FRAGMIN) IN THE PREVENTION OF DEEP VEIN THROMBOSIS IN MEDICAL PATIENTS: A RANDOMIZED DOUBLE-BLIND TRIAL." In XIth International Congress on Thrombosis and Haemostasis. Schattauer GmbH, 1987. http://dx.doi.org/10.1055/s-0038-1643224.
Full textMILLER, E. R. "IMPLEMENTATION OF ADAPTIVE RANDOMIZATIONS FOR CLINICAL TRIALS." In Proceedings of the 5th International ISAAC Congress. WORLD SCIENTIFIC, 2009. http://dx.doi.org/10.1142/9789812835635_0138.
Full textCordeiro, Tatiana Virgínia Fidélis, Aline Silva Ziehe, Tamie Mota Arbex, Barbara Cunha Vasconcellos, Lara Cruz de Senna Fernandes, and Maria teresa de Castro Lima Pereira. "The management of migraine through Acupuncture: a literature review." In XIII Congresso Paulista de Neurologia. Zeppelini Editorial e Comunicação, 2021. http://dx.doi.org/10.5327/1516-3180.339.
Full textReports on the topic "Clinical Trial Randomization"
Gupta, Tejpal, Riddhijyoti Talukdar, Sadhana Kannan, Archya Dasgupta, Abhishek Chatterjee, and Vijay Patil. Meta-Analysis of Standard Temozolomide versus Extended Adjuvant Temozolomide following concurrent Radiochemotherapy in newly-diagnosed Glioblastoma (MASTER-G). INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, December 2021. http://dx.doi.org/10.37766/inplasy2021.12.0114.
Full textLumpkin, Shamsie, Isaac Parrish, Austin Terrell, and Dwayne Accardo. Pain Control: Opioid vs. Nonopioid Analgesia During the Immediate Postoperative Period. University of Tennessee Health Science Center, July 2021. http://dx.doi.org/10.21007/con.dnp.2021.0008.
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