Harmonization of the Practice of Independent Ethics Committees in Italy: Project E-Submission

Feo, Gianfranco De; Chiabrando, Giacomo; Cannovo, Nunzia; Galluccio, Antonio; Tomino, Carlo

doi:10.1371/journal.pone.0048906

Cited by 3 publications

(2 citation statements)

References 7 publications

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“…scientific, legal, and ethics reviews), and ethics reviews for multi-site trials. 4,15,16 Finance and invoicing (24%), clinician and staff availability (23%), clinical overhead (14%), and data management (11%) were also captured under infrastructure costs.…”

Section: Trial Costsmentioning

confidence: 99%

“…Streamlining efforts included concurrent institutional reviews 4,5,46 and harmonized ethics approvals for multi-site trials. 16 Centralizing practices included having a dedicated clinical trials office 22,47 and centralized pathology reviews. 55 Improve accrual was recommended by almost onequarter (24%) of articles.…”

Section: Recommendations To Reduce Trial Costsmentioning

confidence: 99%

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Conducting clinical trials—costs, impacts, and the value of clinical trials networks: A scoping review

et al. 2019

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Background A significant barrier to conducting clinical trials is their high cost, which is driven primarily by the time and resources required to activate trials and reach accrual targets. The high cost of running trials has a substantial impact on their long-term feasibility and the type of clinical research undertaken. Methods A scoping review of the empirical literature on the costs associated with conducting clinical trials was undertaken for the years 2001–2015. Five reference databases were consulted to elicit how trials costs are presented in the literature. A review instrument was developed to extract the content of in-scope papers. Findings were characterized by date and place of publication, clinical disease area, and network/cooperative group designation, when specified. Costs were captured and grouped by patient accrual and management, infrastructure, and the opportunity costs associated with industry funding for trials research. Cost impacts on translational research and health systems were also captured, as were recommendations to reduce trial expenditures. Since articles often cited multiple costs, multiple cost coding was used during data extraction to capture the range and frequency of costs. Results A total of 288 empirical articles were included. The distribution of reported costs was: patient management and accrual costs (132 articles), infrastructure costs (118 articles) and the opportunity costs of industry sponsorship (72 articles). 221 articles reported on the impact of undertaking costly trials on translational research and health systems; of these, the most frequently reported consequences were to research integrity (52% of articles), research capacity (36% of articles) and running low-value trials (34% of articles). 254 articles provided recommendations to reduce trial costs; of these, the most frequently reported recommendations related to improvements in: operational efficiencies (33% of articles); patient accrual (24% of articles); funding for trials and transparency in trials reporting (18% of articles, each). Conclusion Key findings from the review are: 1) delayed trial activation has costs to budgets and research; 2) poor accrual leads to low-value trials and wasted resources; 3) the pharmaceutical industry can be a pragmatic, if problematic, partner in clinical research; 4) organizational know-how and successful research collaboration are benefits of network/cooperative groups; and 5) there are spillover benefits of clinical trials to healthcare systems, including better health outcomes, enhanced research capacity, and drug cost avoidance. There is a need for more economic evaluations of the benefits of clinical research, such as health system use (or avoidance) and health outcomes in cities and health authorities with institutions that conduct clinical research, to demonstrate the affordability of clinical trials, despite their high cost.

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Section: Trial Costsmentioning

confidence: 99%

Section: Recommendations To Reduce Trial Costsmentioning

confidence: 99%

Conducting clinical trials—costs, impacts, and the value of clinical trials networks: A scoping review

et al. 2019

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Localization of clinical research

Richards¹

2021

JIAL

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Clinical research using human participants to further medical knowledge has been at the forefront in 2021. Clinical research studying the efficacy of treatments can be categorised in two broad categories as ‘observational studies’ or ‘clinical trials’. Written from the perspective of a localization project manager at Vitaccess, which conducts global digital research for biopharmaceutical companies, this paper discusses five core challenges that impact the localization of such a study launched in France, Italy, Germany, Belgium, Spain, Japan, the UK, the US and Canada, conducted via a smartphone app. The localization project manager role provides a bridge between translators, revisers, ethics bodies, authors, legal, and medical reviewers, enabling oversight to keep the balance between launching the study globally and enabling each country to have the content and structure tailored to their cultural and linguistic expectations through localization. The main challenges in localizing a real-world evidence study is the complexity and volume of ethical, legal, and medical feedback required for the content of the study, which is further complicated by the need to target different countries and languages. Subjectivity and variance in the feedback per country also pose difficulties. International harmonisation of ethical, medical, and legal reviews of such global studies could streamline the process.

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Research ethics committees: Need for harmonization at the national level, the global and Indian perspective

Walanj¹

2014

Perspect Clin Res

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Ethics committee (EC) organization and standardization is an important aspect of clinical research. There is a healthy trend worldwide to register and/or accredit research ECs reviewing clinical research. This article tries to focus on the existing model of ECs worldwide, as against the Indian backdrop. The article reviews literature, journals, websites, and studies conducted in 10 different countries and outlines the working model of ECs in these countries. The challenges faced during the ethical review, especially in case of multicenter trials, have been identified. A solution has been suggested to overcome these challenges, and to ensure the overall smooth functioning of clinical trials. The article proposes the development of national and regional central ECs to counter the current drawbacks in the ethical review mechanisms in India.

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Harmonization of the Practice of Independent Ethics Committees in Italy: Project E-Submission

Cited by 3 publications

References 7 publications

Conducting clinical trials—costs, impacts, and the value of clinical trials networks: A scoping review

Conducting clinical trials—costs, impacts, and the value of clinical trials networks: A scoping review

Localization of clinical research

Research ethics committees: Need for harmonization at the national level, the global and Indian perspective

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