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Adapt to Translate
2021
European Journal of Analytic Philosophy
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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
2012
Annals of Emergency Medicine
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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
2016
Statistics in Medicine
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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
2017
Clinical Cancer Research
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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
2021
Frontiers in Oncology
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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
2017
SAGE Open Medicine
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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
2019
Trials
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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
2007
Computer Software and Applications Conference (COMPSAC) Proceedings of the IEEE International
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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
2019
Frontiers in Pharmacology
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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
2020
The BMJ (British Medical Journal)
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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
2013
Trials
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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
2021
BMC Geriatrics
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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
2020
Trials
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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
2012
Clinical Trials
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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
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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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