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Form Follows Function: Model-Driven Engineering for Clinical Trials

Jeremy Gibbons
2011 Electronic Proceedings in Theoretical Computer Science  
ever follows function.  ...  In particular, in the CancerGrid project, we have been developing model-driven techniques for the generation of software tools to support clinical trials.  ...  In other words, clinical trials management is crying out for a model-driven engineering (MDE) approach.  ... 
doi:10.4204/eptcs.66.0.1 fatcat:26sr2qkqnzgmbjwaamtg5la4mq

The CancerGrid experience: Metadata-based model-driven engineering for clinical trials

Jim Davies, Jeremy Gibbons, Steve Harris, Charles Crichton
2014 Science of Computer Programming  
In other words, clinical trials management is crying out for a model-driven approach.  ...  , to enable subsequent meta-analysis. • Model-driven generation of software artefacts to run trial. • Four case studies. a b s t r a c t The CancerGrid approach to software support for clinical trials  ...  The CONSORT trials metamodel and the forms-based approach to model-driven engineering are described in a couple of conference papers [24, 18] .  ... 
doi:10.1016/j.scico.2013.02.010 fatcat:xkbamlmonffspc5wxgf7zbg6vi

Form Follows Function [chapter]

Jim Davies, Jeremy Gibbons, Radu Calinescu, Charles Crichton, Steve Harris, Andrew Tsui
2012 Lecture Notes in Computer Science  
follows function -strive for perfection and beauty is the byproduct."  ...  Following the completion of concept modelling, ergonomic user trials and mechanism testing, an initial solution design scheme has been validated, ready for future development.  ... 
doi:10.1007/978-3-642-32355-3_2 fatcat:it4gcw7ynbctpklht6cmrobssq

Function Follows Form ― A Review of Cardiac Cell Therapy ―

Kenta Nakamura, Charles E. Murry
2019 Circulation Journal  
Through a review of the preclinical and clinical trials of cardiac cell therapy, distinguishing the primary mechanism of benefit as either contractile or non-contractile helps appreciate the barriers to  ...  Correspondingly, these cells offer little functional benefit to infarct patients.  ...  We thank Xiulan Yang for providing the immunohistochemistry images. Disclosures K.N. reports no disclosures. C.E.M. is a scientific founder and equity holder in CytoCardia, Inc.  ... 
doi:10.1253/circj.cj-19-0567 pmid:31723070 pmcid:PMC7002039 fatcat:5qeb65a6kfeancvbq5ka7hpx7e

A New Software Development Methodology for Clinical Trial Systems

Li-Min Liu
2013 Advances in Software Engineering  
While developing software for clinical trials, one needs to take into account the similar patterns shared by all clinical trial software.  ...  Based on the properties, a new software development methodology is then proposed specifically for developing electronic clinical trial systems.  ...  Usually a functional system exists to handle current jobs for most software development in other domains. This is not necessarily the case in a clinical trial.  ... 
doi:10.1155/2013/796505 fatcat:hyjmg5lmerfcndlondgkbyrdla

Metadata-driven software for clinical trials

Charles Crichton, Jim Davies, Jeremy Gibbons, Steve Harris, Andrew Tsui, James Brenton
2009 2009 ICSE Workshop on Software Engineering in Health Care  
The model is then used to derive automatically a trial management system customized for that trial: generating electronic case report forms, configuring randomisation and eligibility services, and parameterising  ...  The metamodel is instantiated with metadata elements drawn from a repository, to create a model of a particular clinical trial.  ...  The authors would like to thank the other members of the CancerGrid team, especially Carlos Caldas in Cambridge for his guiding role, and David Rose at the US Veterans' Health Administration for his help  ... 
doi:10.1109/sehc.2009.5069600 dblp:conf/icse/CrichtonDGHTB09 fatcat:eherdolvsjf5dcifequwicpj4m

Model-driven architecture for cancer research

Radu Calinescu, Steve Harris, Jeremy Gibbons, Jim Davies, Igor Toujilov, Sylvia B. Nagl
2007 Fifth IEEE International Conference on Software Engineering and Formal Methods (SEFM 2007)  
across clinical trial boundaries.  ...  The SOA solution generated by the framework is based on an information model of a cancer clinical trial, and comprises components for both the collection and analysis of cancer research data, within and  ...  The authors are grateful to Charlie Crichton, Peter Maccallum, Andrew Tsui and the other members of the CancerGrid team for many insightful discussions during the work on the model-driven development framework  ... 
doi:10.1109/sefm.2007.26 dblp:conf/sefm/CalinescuHGDTN07 fatcat:dut4a5z6wfcbtiqd6os27ecfv4

Can We Grow Valves Inside the Heart? Perspective on Material-based In Situ Heart Valve Tissue Engineering

Carlijn V. C. Bouten, Anthal I. P. M. Smits, Frank P. T. Baaijens
2018 Frontiers in Cardiovascular Medicine  
Although this concept is widely explored for in situ engineered vascular grafts, leading to exciting preclinical and clinical trials (e.g., reviewed by 60 and 61), this was the first long-term pre-clinical  ...  A significant example is the development of a predictive computational model to generate new testable hypotheses for scaffold properties that favor tissue engineered neovessel formation and function (  ... 
doi:10.3389/fcvm.2018.00054 pmid:29896481 pmcid:PMC5987128 fatcat:gkyoa2joybevfg6tqudppudfm4

Advanced models for predicting event occurrence in event-driven clinical trials accounting for patient dropout, cure and ongoing recruitment [article]

Vladimir Anisimov, Stephen Gormley, Rosalind Baverstock, Cynthia Kineza
2021 arXiv   pre-print
We consider event-driven clinical trials, where the analysis is performed once a pre-determined number of clinical events has been reached.  ...  Therefore, in such trials we need to model patient recruitment and event counts together.  ...  the operational design of event-driven clinical trials.  ... 
arXiv:2108.09196v1 fatcat:vgojpedak5gxhon6ytcj2lvnre

Producer T cells: Using genetically engineered T cells as vehicles to generate and deliver therapeutics to tumors

Alexander K. Tsai, Eduardo Davila
2016 Oncoimmunology  
A novel extension of this approach is to utilize engineered T cells to produce and deliver anticancer therapeutics that enhance cytotoxic T cell function and simultaneously inhibit immunosuppressive processes  ...  Redirecting antigen specificity by genetically engineering T cells to stably express receptors has become an effective variant of ACT.  ...  In a clinical trial using NFAT-driven IL-12, remarkably high levels of circulating IL-12 were observed in some patients.  ... 
doi:10.1080/2162402x.2015.1122158 pmid:27467930 pmcid:PMC4910704 fatcat:2iaiffcts5fzhdnvvy2ofmsqfu

Clinical data management: Current status, challenges, and future directions from industry perspectives

Zhengwu Lu, Su
2010 Open Access Journal of Clinical Trials  
CDM should be the owner of driving clinical data-cleaning process in consultation with other stakeholders, such as clinical operations, safety, quality assurance, and sites, and responsible for building  ...  are essential to continued success and to ensure quality data-driven productivity.  ...  The framework for this data-driven personalized vision is centered on the model of predictive, personalized, preemptive, and participatory medicine.  ... 
doi:10.2147/oajct.s8172 fatcat:psyfbp2nczdjxizm2w74io4hri

Series Introduction: Replication-selective microbiological agents: fighting cancer with targeted germ warfare

David H. Kirn
2000 Journal of Clinical Investigation  
Kirn, Editor Table 1 1 Replication-selective microbiological agents in clinical trials for cancer patients .g., ras mutation, EGFR signaling)A Not yet in clinical trials; to enter clinical trials  ...  Table 1 displays a number of replication-selective microorganisms that have recently entered clinical trials, as well as others that will follow shortly.  ... 
doi:10.1172/jci9761 pmid:10749559 pmcid:PMC377493 fatcat:w5vfsbispfbjve4hsrzrnghn44

Challenges in Delivering Decision Support Systems: The MATE Experience [chapter]

Dionisio Acosta, Vivek Patkar, Mo Keshtgar, John Fox
2010 Lecture Notes in Computer Science  
functional model.  ...  The aim of this work is to propose a computational framework to provide a clinical guideline-based DSS for breast cancer MDM.  ...  The Clinical Decision Support functions considered in the model are themselves classified into 7 functional groups as follows: Manage Health Information support for standard and context driven patient  ... 
doi:10.1007/978-3-642-11808-1_11 fatcat:re5knuofo5epvgu5b4qcjxpzmu

Retroviral gene therapy in Germany with a view on previous experience and future perspectives

Michael A. Morgan, Melanie Galla, Manuel Grez, Boris Fehse, Axel Schambach
2021 Gene Therapy  
methods to assess gene therapy vector efficacy and safety (e.g., clonal imbalance, insertion sites), as well as in the design and conduction of clinical gene therapy trials.  ...  AbstractGene therapy can be used to restore cell function in monogenic disorders or to endow cells with new capabilities, such as improved killing of cancer cells, expression of suicide genes for controlled  ...  Acknowledgements We would like to thank all the colleagues who worked in this field for their important contribution and are sorry that we could not incorporate references from all of these fascinating  ... 
doi:10.1038/s41434-021-00237-x pmid:33753908 fatcat:pr3i6hgnsjck7lsuejfrcjmj5m

Engineering cytokines and cytokine circuits

Aileen W. Li, Wendell A. Lim
2020 Science  
W.A.L is adviser to Allogene, a shareholder of Gilead, and has applied for patents on cytokine delivery circuits. A.W.L. is an employee of Lyell.  ...  Following this example, most cytokine engineering strategies use a combination of directed mutagenesis and librarybased screens.  ...  Similarly, a PEGylated form of IFN-a showed longer half-life, and was approved by the FDA for the treatment of melanoma.  ... 
doi:10.1126/science.abb5607 pmid:33243875 pmcid:PMC8628814 fatcat:vfxvczx2orbp3kdwxodvmibiwa
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