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Adapt to Translate

Daria Jadreškić
2021 European Journal of Analytic Philosophy  
The article presents the advantages and limitations of adaptive clinical trials for assessing the effectiveness of medical interventions and specifies the conditions that contributed to their development  ...  I advance two arguments by discussing different cases of adaptive trials.  ...  Acknowledgments I would like to thank two anonymous reviewers for their extremely helpful comments and suggestions, and Lucie White for her detailed feedback on the revised version of the paper.  ... 
doi:10.31820/ejap.17.3.2 fatcat:mmxtunjfffclxcsnesqny23sa4

An Overview of the Adaptive Designs Accelerating Promising Trials Into Treatments (ADAPT-IT) Project

William J. Meurer, Roger J. Lewis, Danilo Tagle, Michael D. Fetters, Laurie Legocki, Scott Berry, Jason Connor, Valerie Durkalski, Jordan Elm, Wenle Zhao, Shirley Frederiksen, Robert Silbergleit (+3 others)
2012 Annals of Emergency Medicine  
The overarching objectives of ADAPT-IT are to identify and quantitatively characterize the ACT methods of greatest potential value in confirmatory phase clinical trials, and to elicit and understand the  ...  Innovations in clinical trials methodology have the potential to improve the quality of knowledge gained from trials, the protection of human subjects, and the efficiency of clinical research.  ...  In addition, the Neurological Emergencies Treatment Trials (NETT) Network Clinical Coordinating Center (U01NS056975) and Statistical and Data Management Center (U01NS059041) are funded by the NINDS.  ... 
doi:10.1016/j.annemergmed.2012.01.020 pmid:22424650 pmcid:PMC3557826 fatcat:7ofy3dpu4nacboxcuu2q7mw5gm

Implementation of adaptive methods in early-phase clinical trials

Gina R. Petroni, Nolan A. Wages, Gautier Paux, Frédéric Dubois
2016 Statistics in Medicine  
This article reviews relevant information that should be included in clinical trial protocols to aid in the acceptance and approval of novel methods.  ...  There has been constant development of novel statistical methods in the design of early-phase clinical trials since the introduction of model-based designs, yet the traditional or modified 3+3 algorithmic  ...  Acknowledgments Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under award numbers R01CA142859 (GRP), P30 CA044579 (GRP) & K25CA181638  ... 
doi:10.1002/sim.6910 pmid:26928191 pmcid:PMC5003756 fatcat:ged4vweqijfx7flfoaroh2rkeq

Adaptive Global Innovative Learning Environment for Glioblastoma: GBM AGILE

Brian M. Alexander, Sujuan Ba, Mitchel S. Berger, Donald A. Berry, Webster K. Cavenee, Susan M. Chang, Timothy F. Cloughesy, Tao Jiang, Mustafa Khasraw, Wenbin Li, Robert Mittman, George H. Poste (+3 others)
2017 Clinical Cancer Research  
The GBM Adaptive Global Innovative Learning Environment (GBM AGILE) is a novel, multi-arm, platform trial designed to address these challenges.  ...  The design of GBM AGILE enables rapid clinical testing of new therapies and biomarkers to speed highly effective therapies to clinical practice. Clin Cancer Res; 24(4); 737-43. Ó2017 AACR.  ...  One potential solution for testing multiple hypotheses within the same clinical trial is a multi-arm, Bayesian adaptively randomized platform trial (13) (14) (15) .  ... 
doi:10.1158/1078-0432.ccr-17-0764 pmid:28814435 fatcat:n6mgnupacfhkhijowcsct76fua

Value of Adaptive Trials and Surrogate Endpoints for Clinical Decision-Making in Rare Cancers

Andriy Krendyukov, Sanjay Singhvi, Markus Zabransky
2021 Frontiers in Oncology  
In conclusion, rare cancer oncologists rate evidence from adaptive clinical trials with as high a value and importance for clinical decision making processes as conventional randomized controlled trials  ...  Practicing physicians were questioned on the importance of different evidence levels, types of adaptive trial design, and categories of surrogate endpoints for clinical decision making.  ...  Broader implementation of adaptive clinical trials and surrogate outcomes are two further potential tools to speed up the InMP development process.  ... 
doi:10.3389/fonc.2021.636561 pmid:33763370 pmcid:PMC7982798 fatcat:cylebpgkgfdf3iyoglxzlqxmyi

The life cycles of six multi-center adaptive clinical trials focused on neurological emergencies developed for the Advancing Regulatory Science initiative of the National Institutes of Health and US Food and Drug Administration: Case studies from the Adaptive Designs Accelerating Promising Treatments Into Trials Project

Timothy C Guetterman, Michael D Fetters, Samkeliso Mawocha, Laurie J Legocki, William G Barsan, Roger J Lewis, Donald A Berry, William J Meurer
2017 SAGE Open Medicine  
In addition, after the trial planning process, the participants more strongly believed that the adaptive design would meet the scientific and medical goals of the studies.  ...  Limited observational data exist that describe the complex process of designing adaptive clinical trials.  ...  The adaptive clinical trial design will increase the overall efficiency of this research. discussions about simulations and created plans for the first set of simulations.  ... 
doi:10.1177/2050312117736228 pmid:29085638 pmcid:PMC5648086 fatcat:jb5quk3a7rbuhamcvg32eium4q

This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols

Francesca Schiavone, Riya Bathia, Krishna Letchemanan, Lindsey Masters, Claire Amos, Anna Bara, Louise Brown, Clare Gilson, Cheryl Pugh, Nafisah Atako, Fleur Hudson, Mahesh Parmar (+9 others)
2019 Trials  
Careful consideration on the practicality of the protocol structure (modular versus single protocol), the longevity and continuity of trial oversight committees, and having clear clinical and scientific  ...  We evaluated the operational aspects of making changes to these adaptive platform trials and identified both common and trial-specific challenges.  ...  MP: originated the multi-arm multi-stage design, provided intellectual and practical input, agreed to final version. RL: provided intellectual and practical input, agreed to final version.  ... 
doi:10.1186/s13063-019-3216-8 pmid:31138317 pmcid:PMC6540525 fatcat:p6wwyziiafcbbgbmfqf4ma4pdq

An Adaptive Security Model for Multi-agent Systems and Application to a Clinical Trials Environment

Liang Xiao, Andrew Peet, Paul Lewis, Srinandan Dashmapatra, Carlos Saez, Madalina Croitoru, Javier Vicente, Horacio Gonzalez-Velez, Magi Lluch i Ariet
2007 Computer Software and Applications Conference (COMPSAC) Proceedings of the IEEE International  
Our approach avoids weaknesses of traditional RBAC approaches and provides a practically usable security model for Multi-agent Systems (MAS).  ...  We present in this paper an adaptive security model for Multi-agent systems. A security meta-model has been developed in which the traditional role concept has been extended.  ...  Acknowledgements This work is supported under the OpenKnowledge and HealthAgents STREP projects funded by EU Framework 6 under Grants: IST-FP6-027253 and IST-FP6-027214.  ... 
doi:10.1109/compsac.2007.55 dblp:conf/compsac/XiaoPLDSCVGA07 fatcat:hvvcj5y3dvcntjb2hzcjpn3zrm

Trial Refresh: A Case for an Adaptive Platform Trial for Pulmonary Exacerbations of Cystic Fibrosis

Andre Schultz, Julie A. Marsh, Benjamin R. Saville, Richard Norman, Peter G. Middleton, Hugh W. Greville, Matthew I. Bellgard, Scott M. Berry, Tom Snelling
2019 Frontiers in Pharmacology  
Bayesian adaptive platform trials hold the promise of addressing clinical uncertainties and informing treatment.  ...  Bayesian adaptive platform trials require substantial amounts of preparation.  ...  REMAP trials aim to greatly improve the efficiency of multi-arm trials using response adaptive randomisation (RAR).  ... 
doi:10.3389/fphar.2019.00301 pmid:30983998 pmcid:PMC6447696 fatcat:qmk57xlow5bezataj43eisqt7a

The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

Munyaradzi Dimairo, Philip Pallmann, James Wason, Susan Todd, Thomas Jaki, Steven A Julious, Adrian P Mander, Christopher J Weir, Franz Koenig, Marc K Walton, Jon P Nicholl, Elizabeth Coates (+7 others)
2020 The BMJ (British Medical Journal)  
We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private  ...  to enhance the reporting of randomised AD clinical trials.  ...  process; whether decision-making criteria were binding or non-binding; pre-planned and actual timing and frequency of interim data looks to inform trial adaptations Comments-This item is a replacement  ... 
doi:10.1136/bmj.m115 pmid:32554564 fatcat:atdvj524gfdshmkmrlrrxflgoe

A comparison of bayesian adaptive randomization and multi-stage designs for multi-arm clinical trials

James Wason, Lorenzo Trippa
2013 Trials  
A comparison of Bayesian adaptive randomization and multi-stage designs for multi-arm clinical trials.  ...  Bayesian adaptive randomization (AR) and multi-arm multi-stage (MAMS) designs are two distinct methods that use patient outcomes to improve the efficiency and ethics of the trial.  ...  Acknowledgements This work is sponsored by MRC (grant numbers G0800860 and MR/J004979/1). We thank the reviewers for useful comments that helped improve the paper.  ... 
doi:10.1186/1745-6215-14-s1-p40 pmcid:PMC3981566 fatcat:j42arl5vurcshmtlt5uu2rot24

A national intervention to support frail older adults in primary care: a protocol for an adapted implementation framework

Joanie Sims-Gould, Jacobi Elliott, Catherine E Tong, Anik Giguère, Sara Mallinson, Paul Stolee
2021 BMC Geriatrics  
Trial Registration U.S. National Library of Medicine, NCT03442426. Registered 22 February 2018– Retrospectively registered.  ...  In each of these phases we will engage in qualitative data collection, including clinical observations, focus groups, in-depth interviews and extensive field notes.  ...  Authors' contributions JSG and JE developed the modified implementation framework with assistance from AG, PS, SM, and CT. PS and JE developed the overarching study protocol.  ... 
doi:10.1186/s12877-021-02395-4 fatcat:vbh4uhhl3vazjis7oyplwjiyz4

The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

Munyaradzi Dimairo, on behalf of the ACE Consensus Group, Philip Pallmann, James Wason, Susan Todd, Thomas Jaki, Steven A. Julious, Adrian P. Mander, Christopher J. Weir, Franz Koenig, Marc K. Walton, Jon P. Nicholl (+8 others)
2020 Trials  
Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also  ...  We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private  ...  Sally Hopewell joined the group during the write up stage to oversee the process on behalf of the CONSORT Group following the sad passing of Doug G Altman.  ... 
doi:10.1186/s13063-020-04334-x pmid:32546273 pmcid:PMC7298968 fatcat:f7l36wogebezdflanzbtizvbca

Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop

Christopher S Coffey, Bruce Levin, Christina Clark, Cate Timmerman, Janet Wittes, Peter Gilbert, Sara Harris
2012 Clinical Trials  
The workshop offered a forum for participants to address issues of ADs that arise at the planning, designing, and execution stages of clinical trials, and to hear the perspectives of influential members  ...  Statisticians and clinical investigators have proposed or implemented a wide variety of adaptations in clinical trials, but specific approaches have met with differing levels of support.  ...  An academic clinical trial group, especially one mostly or entirely reliant on NIH funding, faces an immediate loss of support for their funded positions if a planned multi-year study ends abruptly.  ... 
doi:10.1177/1740774512461859 pmid:23250942 pmcid:PMC5570450 fatcat:2jciw3y5bzagpmu4p5kasdfvke

Optimising personalisation [chapter]

2021 Personalised cancer medicine  
In this chapter we investigate one such adaptive, multi-arm, multi-site trial for lung cancer, examining how the optimising logic of the trial was enacted and the kinds of value that emerged in the process  ...  Stratified medicine and an adaptive trial The National Lung Matrix Trial (Matrix) is a multi-site, multi-arm, adaptive trial of treatments for people with lung cancer, based on the molecular profile of  ... 
doi:10.7765/9781526141019.00008 fatcat:dhmxvz2qdbgu3bkwmjstjghtfu
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