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Search · four archives
21 papers · ranked by Valyu relevance
Vance W. Berger, Louis Joseph Bour, Kerstine Carter, Jonathan J. Chipman + 9 more
'Jonathan J. Chipman' 'Colin C. Everett' 'Nicole Heussen' 'Catherine Hewitt' 'Ralf-Dieter Hilgers' 'Yuqun Abigail Luo' 'Jone Renteria' 'Yevgen Ryeznik' 'Oleksandr Sverdlov' 'Diane Uschner' ''] Background Randomization is the foundation of any clinical trial involving treatment comparison. It helps mitigate selection…
Sameh M. Zamzam, Mosaad Abdel-Aziz, Ahmed Atef, Usama Abdel-Naseer + 5 more
'Mostafa Hamoda' 'Mohamed Salah' 'Hazem Dewidar' 'Louay Elsharkawy' 'Mena E. Abdelmalek'] Background Randomized controlled trials (RCTs) are prospective comparative studies in which study groups are allocated randomly to intervention or serve as controls. RCT is the mainstay to achieve evidence in the literature in…
Marina A Malikova
Randomization was first introduced by the statistician and geneticist Sir RA Fisher, who used this technique in agricultural studies in Britain in the 1920s . When first used in human subjects in early 1930s, randomization was literally accomplished by the toss of a coin to determine treatment assignment group.…
Bonnie J Kaplan, Gerald Giesbrecht, Scott Shannon, Kevin McLeod
Background Both scientists and the public routinely refer to randomized controlled trials (RCTs) as being the 'gold standard' of scientific evidence. Although there is no question that placebo-controlled RCTs play a significant role in the evaluation of new pharmaceutical treatments, especially when it is important to…
José Fausto de Morais, Gecilmar Pereira Borges, Gilmar Fernandes do Prado
The statistical analysis is an important part of the process of assessing the quality of randomized controlled trials, unfortunately it tends to be underestimated or even omitted by editors, in this sense, scales that cover this gap becomes necessary. To build a definition and a scale for assessing the quality of…
Joseph M. Strayhorn Jr.
Randomized controlled trials are ubiquitously spoken of as the “gold standard” for testing interventions and establishing causal relations. This article presents evidence for two premises. First: there are often major problems with randomized designs; it is by no means true that the only good design is a randomized…
Yevgen Ryeznik, Oleksandr Sverdlov
Designs Authors: ['Yevgen Ryeznik' 'Oleksandr Sverdlov'] In this paper, we present Insertus.jl, the Julia package that can help the user generate a randomization sequence of a given length for a multi-arm trial with a pre-specified target allocation ratio and assess the operating characteristics of the chosen…
Rohit Kanrar, Chunlin Li, Zara Ghodsi, Margaret Gamalo
Early-phase clinical trials face the challenge of selecting optimal drug doses that balance safety and efficacy due to uncertain dose-response relationships and varied participant characteristics. Traditional randomized dose allocation often exposes participants to sub-optimal doses by not considering individual…
Joshua Trebach, Ali Graebner, Mark K. Su
“The only way to test a hypothesis is to look for all the information that disagrees with it.” -Karl Popper The word “hypothesis” originates from Greek hypo (“under”) and thesis (“placing”), and its ancient usage was as “a summary of the plot of a classical drama.” Here we will delve into the modern scientific dramas…
Steven E. Bellan, Juliet R.C. Pulliam, Rieke van der Graaf, Spencer J. Fox + 2 more
During emerging epidemics of highly fatal diseases, rapid development and testing of new vaccines may be critical to curbing transmission and saving lives. However, the design of vaccine efficacy trials in such contexts may face considerable logistical, epidemiological, or ethical impediments. Three different vaccine…
Nigel Stallard, Lisa V. Hampson, Norbert Benda, Werner Brannath + 13 more
'Tom Burnett' 'Tim Friede' 'Peter Kimani' 'Franz Koenig' 'Johannes Krisam' 'Pavel Mozgunov' 'Martin Posch' 'James Wason' 'Gernot Wassmer' 'John C. Whitehead' 'S. Faye Williamson' 'Sarah Zohar' 'Thomas Jaki'] Nigel Stallarda1 , Lisa Hampsona * 2 , Norbert Benda3 , Werner Brannath4 , Tom Burnett5 , Tim Friede6 , Peter K.…
Matt D.T. Hitchings, Marc Lipsitch, Rui Wang, Steven E. Bellan
Power considerations for trials evaluating vaccines against infectious diseases are complicated by indirect protective effects of vaccination. While cluster-randomized trials (cRCTs) are less statistically efficient than individually randomized trials (iRCT), a cRCT’s ability to measure direct and indirect vaccine…
Yizhuo Wang, Bing Z. Carter, Ziyi Li, Xuelin Huang
A key component for precision medicine is a good prediction algorithm for patients’ response to treatments. We aim to implement machine learning (ML) algorithms into the response-adaptive randomization (RAR) design and improve the treatment outcomes. We incorporated nine ML algorithms to model the relationship of…
Rob Kessels, Anne M. May, Miriam Koopman, Kit C. B. Roes
A Trial within Cohorts (TwiCs) study design is a trial design that uses the infrastructure of an observational cohort study to initiate a randomized trial. Upon cohort enrollment, cohort participants provided consent for being randomized in future studies without being informed. Once a new treatment is available…
M. Elizabeth Halloran, Kari Auranen, Sarah Baird, Nicole E. Basta + 15 more
Here we urge the adoption of a new paradigm for the design and interpretation of intervention trials in infectious diseases, particularly in emerging infectious disease, that more accurately reflects the dynamics of the transmission process. Interventions in infectious diseases can have indirect effects on those not…
David S. Robertson, James Wason
Response-adaptive designs allow the randomization probabilities to change during the course of a trial based on cumulated response data, so that a greater proportion of patients can be allocated to the better performing treatments. A major concern over the use of response-adaptive designs in practice, particularly from…
Hans Ulrich Burger, Christoph Gerlinger, Chris Harbron, Armin Koch + 3 more
'Martin Posch' 'Justine Rochon' 'Anja Schiel'] 1) Hoffmann-La Roche AG, 2) Statistics and Data Insights, Bayer AG and Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland , 3) Roche Products, 4) Medizinische Hochschule Hannover, 5) Center for Medical Statistics, Informatics, and…
Rocío Titiunik
∗ Prepared for "Advances in Experimental Political Science", edited by James Druckman and Donald Green, to be published by Cambridge University Press. I am grateful to Don Green and Jamie Druckman for their helpful feedback on multiple versions of this chapter, and to Marc Ratkovic and participants at the Advances in…
Anja Collazo, Hans-Georg Kuhn, Tobias Kurth, Marco Piccininni + 1 more
Animal attrition in preclinical experiments can introduce bias in the estimation of causal treatment effects, as surviving animals may not be representative of the entire study population. This can compromise the internal validity of the study, despite randomization at the outset. Directed Acyclic Graphs (DAGs) are…
Prashanth Athri, Vidhya Murali, Pradyumna Y Muralidhar, Cassandra Königs + 4 more
- 1. Department of Computer Science and Engineering, Amrita School of Engineering, Amrita Vishwa Vidyapeetham, Bengaluru, India - 2. PES Center for Pattern Recognition, Department of Computer Science and Engineering, PES University, Bengaluru, India - 3. Bioinformatics and Medical Informatics, Bielefeld University…
Long Qian, Xin Lu, Parvez Haris, Jianyong Zhu + 2 more
Clinical trials are crucial for drug development, but they require significant time and financial resources. Additionally, uncertainties may arise during these trials concerning their results due to concerns surrounding effectiveness, safety, or the enrollment of participants. If robust AI (artificial intelligence)…