Multicenter Studies: Relevance, Design and Implementation

Das, Manoja Kumar

doi:10.1007/s13312-022-2561-y

Cited by 14 publications

(12 citation statements)

References 9 publications

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“…[3][4][5] The country's scholarly article output, particularly in critical care, has stagnated; also, there has been a decline in noncommercial clinical trials. 6,7 Therefore, it is crucial to invigorate clinical research initiatives.…”

Section: Backgrou N Dmentioning

confidence: 99%

“…Obstacles, such as patient recruitment, often hinder clinical research. 6,7 Multicenter collaborative research could provide a solution, as it accelerates patient recruitment, allows for a more diverse patient population, and increases the generalizability of the study compared with single-center studies. 8 However, multicenter research necessitates extensive collaboration among clinicians from various hospitals and demands significant human and financial resources.…”

Section: Backgrou N Dmentioning

confidence: 99%

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Challenges hindering emergency physicians; involvement in multicenter collaborative studies in Japan: A nationwide survey analysis

Yasuda,

Saito,

Goto

et al. 2023

Acute Medicine & Surgery

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AimMulticenter collaborative research accelerates patient recruitment and strengthens evidence. Nevertheless, the factors influencing emergency and critical care physicians’ involvement in such research in Japan remain unclear.MethodsA nationwide web‐based survey conducted in early 2023 targeted emergency physicians working a minimum of 3 days per week in Japan. The survey descriptively assessed their backgrounds, work and research environments, experiences, and perceived impediments and motivators for multicenter research.ResultsOf the 387 respondents, 348 were included in the study, yielding a 5.1% response rate. Women comprised 11% of the participants; 33% worked in university hospitals, 65% served in both emergency departments and intensive care units, and 54% did shift work. Only 12% had designated research time during working hours, with a median of 1 hour per week (interquartile range 0–5 h), including time outside of work. While 73% had participated in multicenter research, 58% noted barriers to participation. The key obstacles were excessive data entry (72%), meeting time constraints (59%), ethical review at each facility (50%), and unique sample collection, such as bronchoalveolar lavage specimens or pathological tissues (51%). The major incentives were networking (70%), data sets reuse (65%), feedback on research results (63%), and recognition from academic societies (63%). Financial rewards were not highly prioritized (38%).ConclusionsWhile valuing clinical research, emergency physicians face barriers, especially data entry burden and limited research time. Networking and sharing research findings motivate them. These insights can guide strategies to enhance collaborative research in emergency and critical care in Japan.

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Section: Backgrou N Dmentioning

confidence: 99%

Section: Backgrou N Dmentioning

confidence: 99%

Challenges hindering emergency physicians; involvement in multicenter collaborative studies in Japan: A nationwide survey analysis

Yasuda,

Saito,

Goto

et al. 2023

Acute Medicine & Surgery

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“…1 Randomized clinical trials (RCTs) are widely recognized as the criterion standard of evidence-based clinical care, 2 with multicenter trials promising more rapid + Invited Commentary + Supplemental content recruitment, larger sample sizes, and greater generalizability. 3 However, planning, launching, and conducting a multicenter RCT (mRCT) presents myriad challenges to researchers, including study design; site selection and start-up; contracting and single institutional review board (IRB) approvals; recruitment and retention of a diverse, generalizable participant population; and data management and reporting. [4][5][6][7] NCATS funded 3 Trial Innovation Centers (TICs) and 1 Recruitment Innovation Center (RIC) to organize and support trial opportunities across the CTSA Consortium (more than 60 institutions and their affiliates).…”

Section: Introductionmentioning

confidence: 99%

“…The National Center for Advancing Translational Sciences (NCATS) established the Trial Innovation Network (TIN) in 2016 to transform the Clinical and Translational Science Award (CTSA) network’s ability to implement multicenter trials . Randomized clinical trials (RCTs) are widely recognized as the criterion standard of evidence-based clinical care, with multicenter trials promising more rapid recruitment, larger sample sizes, and greater generalizability . However, planning, launching, and conducting a multicenter RCT (mRCT) presents myriad challenges to researchers, including study design; site selection and start-up; contracting and single institutional review board (IRB) approvals; recruitment and retention of a diverse, generalizable participant population; and data management and reporting …”

Section: Introductionmentioning

confidence: 99%

Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials

Harris,

Dunsmore,

Atkinson

et al. 2023

JAMA Netw Open

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ImportanceMulticenter 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.ObservationsThe 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 RelevanceThe 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.

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“…Clinical trials are essential for developing and testing healthcare treatments, and multi-center clinical trials allow for larger, more accurate, and generalizable assessment of efficacy and effectiveness [4]. Adequately powered randomized controlled trials are the gold standard for testing treatments and practice patterns, but there remain significant roadblocks to trial design and conduct [5][6][7].…”

Section: Introductionmentioning

confidence: 99%

Development, implementation, and dissemination of operational innovations across the trial innovation network

Palm,

Edwards,

Wieber

et al. 2023

J. Clin. Trans. Sci.

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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.

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Multicenter Studies: Relevance, Design and Implementation

Cited by 14 publications

References 9 publications

Challenges hindering emergency physicians; involvement in multicenter collaborative studies in Japan: A nationwide survey analysis

Challenges hindering emergency physicians; involvement in multicenter collaborative studies in Japan: A nationwide survey analysis

Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials

Development, implementation, and dissemination of operational innovations across the trial innovation network

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