Cycle Time Metrics for Multisite Clinical Trials in the United States

Abbott, Diana; Califf, Robert M.; Morrison, Briggs W.; Pierre, Christine; Bolte, Jean; Chakraborty, Swati

doi:10.1177/2168479012464371

Cited by 21 publications

(20 citation statements)

References 32 publications

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“…This figure agrees with an unpublished national report issued by the Korea Centers for Disease Control and Prevention (KCDC) in 2009, in which approximately 70% of the general public said that they had heard of clinical research ( 20 ). This speaks for the growing interest of the public in clinical research, as well as for the unique distribution of clinical research infrastructure in Korea, where most clinical research takes place in Seoul ( 21 ).…”

Section: Discussionmentioning

confidence: 99%

Knowledge and Perception about Clinical Research Shapes Behavior: Face to Face Survey in Korean General Public

et al. 2016

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Considering general public as potential patients, identifying factors that hinder public participation poses great importance, especially in a research environment where demands for clinical trial participants outpace the supply. Hence, the aim of this study was to evaluate knowledge and perception about clinical research in general public. A total of 400 Seoul residents with no previous experience of clinical trial participation were selected, as representative of population in Seoul in terms of age and sex. To minimize selection bias, every fifth passer-by was invited to interview, and if in a cluster, person on the very right side was asked. To ensure the uniform use of survey, written instructions have been added to the questionnaire. Followed by pilot test in 40 subjects, the survey was administered face-to-face in December 2014. To investigate how perception shapes behavior, we compared perception scores in those who expressed willingness to participate and those who did not. Remarkably higher percentage of responders stated that they have heard of clinical research, and knew someone who participated (both, P < 0.001) compared to India. Yet, the percentage of responders expressed willingness to participate was 39.3%, a significantly lower rate than the result of the India (58.9% vs. 39.3%, P < 0.001). Treatment benefit was the single most influential reason for participation, followed by financial gain. Concern about safety was the main reason for refusal, succeeded by fear and lack of trust. Public awareness and educational programs addressing these negative perceptions and lack of knowledge will be effective in enhancing public engaged in clinical research.

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Section: Discussionmentioning

confidence: 99%

Knowledge and Perception about Clinical Research Shapes Behavior: Face to Face Survey in Korean General Public

et al. 2016

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“…Regulatory delays on a site level are dependent on whether a site uses a local Institutional Review Board (IRB)/ethics committee (EC) or is able to utilize a central IRB/EC. Evidence suggests the use of a centralized IRB that governs multiple sites, rather than a local IRB overseeing each site, significantly reduces time to IRB approval [ 15 , 16 ]. In a retrospective study, central IRBs were associated with significantly shorter cycle times, including conducting protocol review within an average of 7 days as compared to 35 days for local IRBs [ 15 ].…”

Section: Resultsmentioning

confidence: 99%

Drivers of Start-Up Delays in Global Randomized Clinical Trials

Lai

Forney

Brinton

et al. 2020

Ther Innov Regul Sci

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Background Global, randomized clinical trials are extremely complex. Trial start-up is a critical phase and has many opportunities for delay which adversely impact the study timelines and budget. Understanding factors that contribute to delay may help clinical trial managers and other stakeholders to work more efficiently, hastening patient access to potential new therapies. Methods We reviewed the available literature related to start-up of global, Phase III clinical trials and then created a fishbone diagram detailing drivers contributing to start-up delays. The issues identified were used to craft a checklist to assist clinical trial managers in more efficient trial start-up. Results We identified key drivers for start-up delays in the following categories: regulatory, contracts and budgets, insurance, clinical supplies, site identification and selection, site activation, and inefficient processes/pitfalls. Conclusion Initiating global randomized clinical trials is a complex endeavor, and reasons for delay are well documented in the literature. By using a checklist, clinical trial managers may mitigate some delays and get clinical studies initiated as soon as possible.

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“…IRB review is just one aspect of the study start-up and business operations processes for clinical trials that could benefit from standard measures of efficiency [24]. Other approaches, such as monitoring checklists and quality assurance procedures, could be standardized by research sponsors, regulators, or clinical trial sites themselves to ensure that clinical trials are implemented as designed, regulations governing the conduct of clinical trials are followed, and data used to assess treatment effects are valid.…”

Section: Setting Standards: Fundamental To Improving Clinical Trialsmentioning

confidence: 99%

It's Time to Harmonize Clinical Trial Site Standards

Lewis-Hall¹,

Bajpai²,

Blumenfeld³

et al. 2017

NAM Perspectives

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Climbing costs and lengthy time frames of clinical trials are significant bottlenecks in medical product development. Despite the fact that scientific discoveries yield many new possible targets for developing into therapies, the capacity and resources with which to develop these targets are limited, thereby leaving potentially valuable discoveries undeveloped and unrealized. Under the aegis of the Clinical Trial Site Standards Harmonization Action Collaborative ("the Collaborative") of the Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine, clinical research stakeholders set out to discuss opportunities to improve clinical trial site functioning, with the goal of increasing productivity in medical product development. Our conclusion: harmonization of standards for clinical trial sites has significant promise in improving clinical trials. Standards would also be essential to the formation of a site accreditation system in the United States, should a consensus emerge on the need for such a system. This paper synthesizes the results of the work conducted to inform discussions of the Collaborative. This paper may serve as a launching point for harmonizing requirements applied to clinical trial sites and the development of standards. A clinical trial infrastructure that reduces redundancies and increases efficiencies would, in turn, accelerate the pace and productivity of new product development, to the benefit of patients and society. DISCUSSION PAPER Perspectives | Expert Voices in Health & Health Care Investing More, Producing Less Patients are in need of new medicines to treat an array of rare, common, and complex diseases. By its nature, the development of a new medicine, vaccine, device, or diagnostic is a careful process, one executed in keeping with the cardinal rule of medicine: "First, do no harm." Today, however, biopharmaceutical development faces an efficiency crisis, and the stakes for reform are high. Without a substantial increase in the rate of clinical success and subsequent drug approvals, many observers believe innovators will be unable to bring forward enough new medicines to sustain investment in research and development (R&D) activities [1]. The costs of development have skyrocketed, but

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Cycle Time Metrics for Multisite Clinical Trials in the United States

Cited by 21 publications

References 32 publications

Knowledge and Perception about Clinical Research Shapes Behavior: Face to Face Survey in Korean General Public

Knowledge and Perception about Clinical Research Shapes Behavior: Face to Face Survey in Korean General Public

Drivers of Start-Up Delays in Global Randomized Clinical Trials

It's Time to Harmonize Clinical Trial Site Standards

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