LIVIVO - Search results -

Search results

Result 1 - 10 of total 11

Search options

Book ; Online ; E-Book: Broadly engaged team science in clinical and translational research

Lerner, Debra / Palm, Marisha E. / Concannon, Thomas W.

2022

Author's details	Debra Lerner, Marisha E. Palm, Thomas W. Concannon, editors
Keywords	Medicine/Research
Subject code	610.72
Language	English
Size	1 online resource (254 pages)
Publisher	Springer
Publishing place	Cham, Switzerland
Document type	Book ; Online ; E-Book
Remark	Zugriff für angemeldete ZB MED-Nutzerinnen und -Nutzer
ISBN	3-030-83028-4 ; 9783030830274 ; 978-3-030-83028-1 ; 3030830276
Database	ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

Full text online

Accessible to users with ZB MED library card

Order via subito

This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Details ▾
- Full text online
- Order with fees

Article ; Online: Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis.

Palm, Marisha E / Lindsell, Christopher J / Selker, Harry P

Journal of clinical and translational science

2021 Volume 6, Issue 1, Page(s) e52

Abstract: Background: The Clinical and Translational Science Award Program (CTSA) Trial Innovation Network (TIN) was launched in 2016 to increase the efficiency and effectiveness of multisite trials by supporting the development of national infrastructure. With ... ...

Abstract	Background: The Clinical and Translational Science Award Program (CTSA) Trial Innovation Network (TIN) was launched in 2016 to increase the efficiency and effectiveness of multisite trials by supporting the development of national infrastructure. With the advent of the COVID-19 pandemic, it was therefore well-positioned to support clinical trial collaboration. The TIN was leveraged to support two initiatives: (1) to create and evaluate a mechanism for coordinating Data and Safety Monitoring Board (DSMB) activities among multiple ongoing trials of the same therapeutic agents, and (2) to share data across clinical trials so that smaller, likely underpowered studies, could be combined to produce meaningful and actionable data through pooled analyses. The success of these initiatives was understood to be dependent upon the willingness of investigators, study teams, and US National Institutes of Health research networks to collaborate and share information. Methods: To inform these two initiatives, we conducted semistructured interviews with members of CTSA hubs and clinical research stakeholders that probed barriers and facilitators to collaboration. Thematic analysis identified topics relevant across institutions, individuals, and DSMBs. Results: The DSMB coordination initiative was viewed as less controversial, while the data pooling initiative was seen as complex because of its potential impact on publication, authorship, and the rewards of discovery. Barriers related to resources, centralization, and technical work were significant, but interviewees suggested these could be handled by the provision of central funding and supportive frameworks. The more intractable findings were related to issues around credit and ownership of data. Conclusion: Based on our interviews, we conclude with nine recommended actions that can be implemented to support collaboration.
Language	English
Publishing date	2021-10-07
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2021.866
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Article ; Online: From a decentralized clinical trial to a decentralized and clinical-trial-in-a-box platform: Towards patient-centric and equitable trials.

Dulko, Dorothy / Kwong, Manlik / Palm, Marisha E / Trinquart, Ludovic / Selker, Harry P

Journal of clinical and translational science

2023 Volume 7, Issue 1, Page(s) e236

Abstract: Background/objective: Despite the intuitive attractiveness of bringing research to participants rather than making them come to central study sites, widespread decentralized enrollment has not been common in clinical trials.: Methods: The need for ... ...

Abstract	Background/objective: Despite the intuitive attractiveness of bringing research to participants rather than making them come to central study sites, widespread decentralized enrollment has not been common in clinical trials. Methods: The need for clinical research in the context of the COVID-19 pandemic, along with innovations in technology, led us to use a decentralized trial approach in our Phase 2 COVID-19 trial. We used real-time acquisition and transmission of health-related data using home-based monitoring devices and mobile applications to assess outcomes. This approach not only avoids spreading COVID-19 but it also can support inclusion of participants in more diverse socioeconomic circumstances and in rural settings. Results: Our team developed and deployed a decentralized trial platform to support patient engagement and adverse event reporting. Clinicians, engineers, and informaticians on our research team developed a Clinical-Trial-in-a-Box tool to optimally collect and analyze data from multiple decentralized platforms. Conclusion: Applying the decentralized model in Long COVID, using digital health technology and personal devices integrated with our telehealth platform, we share the lessons learned from our work, along with challenges and future possibilities.
Language	English
Publishing date	2023-10-09
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2023.629
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Article ; Online: Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network.

Lane, Karen / Palm, Marisha E / Marion, Eve / Kay, Marie T / Thompson, Dixie / Stroud, Mary / Boyle, Helen / Hillery, Shannon / Nanni, Angeline / Hildreth, Meghan / Nelson, Sarah / Burr, Jeri S / Edwards, Terri / Poole, Lori / Waddy, Salina P / Dunsmore, Sarah E / Harris, Paul / Wilkins, Consuelo / Bernard, Gordon R /

Dean, J Michael / Dwyer, Jamie / Benjamin, Daniel K / Selker, Harry P / Hanley, Daniel F / Ford, Daniel E

Journal of clinical and translational science

2023 Volume 7, Issue 1, Page(s) e131

Abstract: One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but ...

Abstract	One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities. This communication draws on the experience of the National Center for Advancing Translational Science (NCATS) Trial Innovation Network (TIN) to develop approaches for enhancing the informativeness of clinical trials. We distilled this information into three principles: (1) assemble a diverse team, (2) leverage existing processes and systems, and (3) carefully consider budgets and contracts. The TIN, comprised of NCATS, three Trial Innovation Centers, a Recruitment Innovation Center, and 60+ CTSA Program hubs, provides resources to investigators who are proposing multicenter collaborations. In addition to sharing principles that support the informativeness of clinical trials, we highlight TIN-developed resources relevant for multicenter trial initiation and conduct.
Language	English
Publishing date	2023-05-25
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2023.560
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Article ; Online: Development, implementation, and dissemination of operational innovations across the trial innovation network.

Journal of clinical and translational science

2023 Volume 7, Issue 1, Page(s) e251

Abstract: Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are ... ...

Abstract	Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations. We provide an overview of the roadblocks that led to opportunities for operational innovation, our work to develop, define, and map innovations across the network, and how we implemented and disseminated mature innovations.
Language	English
Publishing date	2023-10-20
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2023.658
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Article ; Online: The Trial Innovation Network Liaison Team: building a national clinical and translational community of practice.

Journal of clinical and translational science

2023 Volume 7, Issue 1, Page(s) e249

Abstract: In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ ... ...

Abstract	In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ Clinical and Translational Science Award (CTSA) hubs across the country to support the design and conduct of successful multicenter trials. A dedicated Hub Liaison Team (HLT) was established within each CTSA to facilitate connection between the hubs and the newly launched Trial and Recruitment Innovation Centers. Each HLT serves as an expert intermediary, connecting CTSA Hub investigators with TIN support, and connecting TIN research teams with potential multicenter trial site investigators. The cross-consortium Liaison Team network was developed during the first TIN funding cycle, and it is now a mature national network at the cutting edge of team science in clinical and translational research. The CTSA-based HLT structures and the external network structure have been developed in collaborative and iterative ways, with methods for shared learning and continuous process improvement. In this paper, we review the structure, function, and development of the Liaison Team network, discuss lessons learned during the first TIN funding cycle, and outline a path toward further network maturity.
Language	English
Publishing date	2023-11-06
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2023.675
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Article ; Online: Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned.

Hanley, Daniel F / Bernard, Gordon R / Wilkins, Consuelo H / Selker, Harry P / Dwyer, Jamie P / Dean, J Michael / Benjamin, Daniel Kelly / Dunsmore, Sarah E / Waddy, Salina P / Wiley, Kenneth L / Palm, Marisha E / Mould, W Andrew / Ford, Daniel F / Burr, Jeri S / Huvane, Jacqueline / Lane, Karen / Poole, Lori / Edwards, Terri L / Kennedy, Nan /

Boone, Leslie R / Bell, Jasmine / Serdoz, Emily / Byrne, Loretta M / Harris, Paul A

Journal of clinical and translational science

2023 Volume 7, Issue 1, Page(s) e170

Abstract: New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by ... ...

Abstract	New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or "hybrid" trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.
Language	English
Publishing date	2023-07-25
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2023.597
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Article ; Online: Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials.

Harris, Paul A / Dunsmore, Sarah E / Atkinson, Jane C / Benjamin, Daniel Kelly / Bernard, Gordon R / Dean, J Michael / Dwyer, Jamie P / Ford, Daniel F / Selker, Harry P / Waddy, Salina P / Wiley, Kenneth L / Wilkins, Consuelo H / Cook, Sarah K / Burr, Jeri S / Edwards, Terri L / Huvane, Jacqueline / Kennedy, Nan / Lane, Karen / Majkowski, Ryan /

Nelson, Sarah / Palm, Marisha E / Stroud, Mary / Thompson, Dixie D / Busacca, Linda / Elkind, Mitchell S V / Kimberly, Robert P / Reilly, Muredach P / Hanley, Daniel F

JAMA network open

2023 Volume 6, Issue 10, Page(s) e2336470

Abstract: Importance: Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. ... ...

Abstract	Importance: Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. The Trial Innovation Network (TIN), established in 2016 to partner with the Clinical and Translational Science Award (CTSA) Consortium of academic medical institutions in the implementation of mRCTs, consists of 3 Trial Innovation Centers (TICs) and 1 Recruitment Innovation Center (RIC). This unique partnership has aimed to address critical roadblocks that impede the design and conduct of mRCTs, in expectation of accelerating the translation of novel interventions to clinical practice. The TIN's challenges and achievements are described in this article, along with examples of innovative resources and processes that may serve as useful models for other clinical trial networks providing operational and recruitment support. Observations: The TIN has successfully integrated more than 60 CTSA institution program hubs into a functional network for mRCT implementation and optimization. A unique support system for investigators has been created that includes the development and deployment of novel tools, operational and recruitment services, consultation models, and rapid communication pathways designed to reduce delays in trial start-up, enhance recruitment, improve engagement of diverse research participants and communities, and streamline processes that improve the quality, efficiency, and conduct of mRCTs. These resources and processes span the clinical trial spectrum and enable the TICs and RIC to serve as coordinating centers, data centers, and recruitment specialists to assist trials across the National Institutes of Health and other agencies. The TIN's impact has been demonstrated through its response to both historical operational challenges and emerging public health emergencies, including the national opioid public health crisis and the COVID-19 pandemic. Conclusions and relevance: The TIN has worked to reduce barriers to implementing mRCTs and to improve mRCT processes and operations by providing needed clinical trial infrastructure and resources to CTSA investigators. These resources have been instrumental in more quickly and efficiently translating research discoveries into beneficial patient treatments.
MeSH term(s)	United States ; Humans ; COVID-19 ; Pandemics ; Translational Science, Biomedical ; Awards and Prizes ; Communication
Language	English
Publishing date	2023-10-02
Publishing country	United States
Document type	Multicenter Study ; Journal Article ; Research Support, N.I.H., Extramural
ISSN	2574-3805
ISSN (online)	2574-3805
DOI	10.1001/jamanetworkopen.2023.36470
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Article ; Online: Key issues for stakeholder engagement in the development of health and healthcare guidelines.

Petkovic, Jennifer / Magwood, Olivia / Lytvyn, Lyubov / Khabsa, Joanne / Concannon, Thomas W / Welch, Vivian / Todhunter-Brown, Alex / Palm, Marisha E / Akl, Elie A / Mbuagbaw, Lawrence / Arayssi, Thurayya / Avey, Marc T / Marusic, Ana / Morley, Richard / Saginur, Michael / Slingers, Nevilene / Texeira, Ligia / Ben Brahem, Asma / Bhaumik, Soumyadeep /

Bou Akl, Imad / Crowe, Sally / Dormer, Laura / Ekanem, Comfort / Lang, Eddy / Kianzad, Behrang / Kuchenmüller, Tanja / Moja, Lorenzo / Pottie, Kevin / Schünemann, Holger / Tugwell, Peter

Research involvement and engagement

2023 Volume 9, Issue 1, Page(s) 27

Abstract: Established in 2015, the Multi-Stakeholder Engagement (MuSE) Consortium is an international network of over 120 individuals interested in stakeholder engagement in research and guidelines. The MuSE group is developing guidance for stakeholder engagement ... ...

Abstract	Established in 2015, the Multi-Stakeholder Engagement (MuSE) Consortium is an international network of over 120 individuals interested in stakeholder engagement in research and guidelines. The MuSE group is developing guidance for stakeholder engagement in the development of health and healthcare guideline development. The development of this guidance has included multiple meetings with stakeholders, including patients, payers/purchasers of health services, peer review editors, policymakers, program managers, providers, principal investigators, product makers, the public, and purchasers of health services and has identified a number of key issues. These include: (1) Definitions, roles, and settings (2) Stakeholder identification and selection (3) Levels of engagement, (4) Evaluation of engagement, (5) Documentation and transparency, and (6) Conflict of interest management. In this paper, we discuss these issues and our plan to develop guidance to facilitate stakeholder engagement in all stages of the development of health and healthcare guideline development.
Language	English
Publishing date	2023-04-28
Publishing country	England
Document type	Journal Article
ZDB-ID	2834246-X
ISSN	2056-7529 ; 2056-7529
ISSN (online)	2056-7529
ISSN	2056-7529
DOI	10.1186/s40900-023-00433-6
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Article ; Online: A Useful and Sustainable Role for N-of-1 Trials in the Healthcare Ecosystem.

Selker, Harry P / Cohen, Theodora / D'Agostino, Ralph B / Dere, Willard H / Ghaemi, S Nassir / Honig, Peter K / Kaitin, Kenneth I / Kaplan, Heather C / Kravitz, Richard L / Larholt, Kay / McElwee, Newell E / Oye, Kenneth A / Palm, Marisha E / Perfetto, Eleanor / Ramanathan, Chandra / Schmid, Christopher H / Seyfert-Margolis, Vicki / Trusheim, Mark / Eichler, Hans-Georg

Clinical pharmacology and therapeutics

2021 Volume 112, Issue 2, Page(s) 224–232

Abstract: Clinicians and patients often try a treatment for an initial period to inform longer-term therapeutic decisions. A more rigorous approach involves N-of-1 trials. In these single-patient crossover trials, typically conducted in patients with chronic ... ...

Abstract	Clinicians and patients often try a treatment for an initial period to inform longer-term therapeutic decisions. A more rigorous approach involves N-of-1 trials. In these single-patient crossover trials, typically conducted in patients with chronic conditions, individual patients are given candidate treatments in a double-blinded, random sequence of alternating periods to determine the most effective treatment for that patient. However, to date, these trials are rarely done outside of research settings and have not been integrated into general care where they could offer substantial benefit. Designating this classical, N-of-1 trial design as type 1, there also are new and evolving uses of N-of-1 trials that we designate as type 2. In these, rather than focusing on optimizing treatment for chronic diseases when multiple approved choices are available, as is typical of type 1, a type 2 N-of-1 trial tests treatments designed specifically for a patient with a rare disease, to facilitate personalized medicine. While the aims differ, both types face the challenge of collecting individual-patient evidence using standard, trusted, widely accepted methods. To fulfill their potential for producing both clinical and research benefits, and to be available for wide use, N-of-1 trials will have to fit into the current healthcare ecosystem. This will require generalizable and accepted processes, platforms, methods, and standards. This also will require sustainable value-based arrangements among key stakeholders. In this article, we review opportunities, stakeholders, issues, and possible approaches that could support general use of N-of-1 trials and deliver benefit to patients and the healthcare enterprise. To assess and expand the benefits of N-of-1 trials, we propose multistakeholder meetings, workshops, and the generation of methods, standards, and platforms that would support wider availability and the value of N-of-1 trials.
MeSH term(s)	Delivery of Health Care ; Ecosystem ; Humans ; Treatment Outcome
Language	English
Publishing date	2021-10-20
Publishing country	United States
Document type	Journal Article ; Review ; Research Support, N.I.H., Extramural
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.2425
Database	MEDical Literature Analysis and Retrieval System OnLINE

In stock of ZB MED Cologne/Königswinter

Zs.A 20: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (1.OG)
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾
- See ZB MED holdings
- Order with fees

To top

Full text online

Kategorien

Order via subito

Inter-library loan at ZB MED

More links

Kategorien

Order via subito

Inter-library loan at ZB MED

More links

Kategorien

Order via subito

Inter-library loan at ZB MED

More links

Kategorien

Order via subito

Inter-library loan at ZB MED

More links

Kategorien

Order via subito

Inter-library loan at ZB MED

More links

Kategorien

Order via subito

Inter-library loan at ZB MED

More links

Kategorien

Order via subito

Inter-library loan at ZB MED

More links

Kategorien

Order via subito

Inter-library loan at ZB MED

More links

Kategorien

Order via subito

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito