18 papers · ranked by Valyu relevance
John D. Seeger, Kourtney J. Davis, Michelle R. Iannacone, Wei Zhou + 5 more
1. External controls may be needed to provide context to efficacy and/or safety in a trial that is single-arm or becomes single-arm (through a long-term extension). 2. Selection of an appropriate, fit-for-purpose data source is important. 3. Both selection bias and information bias need to be addressed in the design…
Timothy A. Yap, Ira Jacobs, Elodie Baumfeld Andre, Lauren J. Lee + 2 more
Randomized controlled trials (RCTs) that assess overall survival are considered the “gold standard” when evaluating the efficacy and safety of a new oncology intervention. However, single-arm trials that use surrogate endpoints (e.g., objective response rate or duration of response) to evaluate clinical benefit have…
Mahta Jahanshahi, Keith Gregg, Gillian Davis, Adora Ndu + 5 more
The regulatory standards of the United States Food and Drug Administration (FDA) require substantial evidence of effectiveness from adequate and well-controlled trials that typically use a valid comparison to an internal concurrent control. However, when it is not feasible or ethical to use an internal control…
Artak Khachatryan, Stephanie H Read, Terri Madison
Comparator arms in randomized clinical trials may be impractical and/or unethical to assemble in rare diseases. In the absence of comparator arms, evidence generated from external control studies has been used to support successful regulatory submissions and health technology assessments (HTA). However, conducting…
Timothy H. Hyndman, Ross S. Bowden, Andrew P. Woodward, Daniel S. J. Pang + 1 more
'Daniel S. J. Pang' 'Jordan O. Hampton'] Studies assessing animal pain in veterinary research are often performed primarily for the benefit of animals. Frequently, the goal of these studies is to determine whether the analgesic effect of a novel treatment is clinically meaningful, and therefore has the capacity to…
Gerd Rippin, Joan Largent, Wilhelmina Elisabeth Hoogendoorn, Héctor Sanz + 2 more
Though there is only one term for the gold standard of Randomized Controlled Trials the terminology used for controlled research involving external data is diverse. Common terms include External Comparator/Control Arm study, Externally Controlled Trial, Synthetic Control study and Historical Control study. The term…
Jiali Liu, Minghong Yao, Mingqi Wang, Wan Jie + 9 more
[zoi250852t3] shows the methodological characteristics involved in generating external controls. Of the 180 ECTs, 164 (91.1%) reported important covariates, of which 37 (22.6%) specified the methods used to identify important covariates and 8 (4.9%) were prespecified in the protocol or the statistical analysis plan.…
Zhiwei Zhang, Peisong Han, Wei Zhang
There is growing interest in a hybrid control design for treatment evaluation, where a randomized controlled trial is augmented with external control data from a previous trial or a real world data source. The hybrid control design has the potential to improve efficiency but also carries the risk of introducing bias.…
Rickard Karlsson, Guanbo Wang, Jesse H. Krijthe, Issa J Dahabreh
One approach for increasing the efficiency of randomized trials is the use of "external controls" – individuals who received the control treatment in the trial during routine practice or in prior experimental studies. Existing external control methods, however, can have substantial bias if the populations underlying…
Pawel Kudzia, Stephen N. Robinovich, J. Maxwell Donelan
Our legs act as our primary contact with the surrounding environment, generating external forces that enable agile motion. To be agile, the nervous system has to control both the magnitude of the force that the feet apply to the ground and the point of application of this force. The purpose of this study was to…
Hubert Makaruk, Jared M. Porter, Jerzy Sadowski, Anna Bodasińska + 3 more
The penalty kick is of great importance in the sport of soccer. Therefore, the aim of this study was to test predictions of the OPTIMAL theory and identify key attentional and motivational factors that impact the accuracy of the penalty kick. The following six groups of skilled participants performed penalty kicks…
Kristen B. Hunter, Kristen Koenig, Marie‐Abèle Bind
The goal of a well-controlled study is to remove unwanted variation when estimating the causal effect of the intervention of interest. Experiments conducted in the basic sciences frequently achieve this goal using experimental controls, such as "negative" and "positive" controls, which are measurements designed to…
Manie Tadayon, Greg Pottie
Educational systems have traditionally been evaluated using cross-sectional studies, namely, examining a pretest, posttest, and single intervention. Although this is a popular approach, it does not model valuable information such as confounding variables, feedback to students, and other real-world deviations of studies…
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…
Szu Szu Ling, Fabrice Saffre, Deborah L. Gater, Lilia Halim + 1 more
Computer quiz games are introduced to improve teaching and learning in a freshman engineering chemistry course in an English-as-a-Second-Language (ESL) environment. These quiz games are developed and implemented as a supplemental and augmentative tool to enhance traditionally delivered lectures. The paper shows an…
Nadav Aridan, Gabriel Pelletier, Lesley K Fellows, Tom Schonberg
Cue-approach training (CAT) is a novel paradigm that has been shown to induce preference changes towards items without external reinforcements. In the task the mere association of a neutral cue and a speeded button response has been shown to induce a behavioral change lasting months. This paradigm includes several…
Authors not listed
Photolabile protecting groups (PPGs) or photocages enable facile masking of molecular functions and their controlled release by light irradiation. Because of the ease of PPG installment, effective abolishment of the protected function, and tunable photorelease, applications are found in all areas of applied chemistry.…
Van N. T. La, Stanley Nicholson, Amna Haneef, Lulu Kang + 1 more
Some data are just underappreciated. Maybe they look different or come from a different background than most other data. Maybe they don't fit neatly into common notions of what data on a ``curve'' should look like. Whatever the case, they are pigeonholed into a restricted role that limits their contributions. But if…