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2.
J Clin Oncol ; : JCO2400961, 2024 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-39079075

RESUMO

Strategies to bring clinical trials closer to patients gained momentum during the COVID-19 pandemic, enabling more participants to receive treatment and/or testing in their local communities. Incorporation of decentralized trial elements presents both opportunities and challenges, spanning regulatory, technical, and operational aspects. This ASCO research statement includes timely consensus-driven recommendations and a call for engagement of all research stakeholders. ASCO held multistakeholder meetings with leaders in oncology research and concluded that research-related regulatory and administrative requirements and burdens present critical barriers to decentralizing trials. One example is sponsor and contract research organization (CRO) use of US Food and Drug Administration (FDA)'s Statement of Investigator (Form 1572), which was found to exceed FDA's stated intent and used in conservative ways disproportionate to potential risks to participants and scientific integrity. As a result, research sites experience an avalanche of downstream administrative and regulatory activities that consume considerable resources. This statement recommends four key solutions to address such barriers and recalibrate regulatory and administrative expectations for decentralizing trials: (1) FDA should engage the research community in a public-private partnership to modernize standards and enable local access to trials; (2) sponsors and CROs should develop standards and protocols that accommodate flexible approaches, enable local participation, provide clarity around roles and requirements, and promote consistency; (3) research centers, networks, and sites should update policies and procedures to implement decentralized trial elements; and (4) research community should develop a streamlined, uniform mechanism to simplify regulatory data collection and documentation and use it consistently across trials. We can and must prioritize a concerted commitment to simplify and streamline regulatory requirements and practices to broaden access to and participation in cancer clinical trials.

3.
JCO Clin Cancer Inform ; 4: 854-864, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32970483

RESUMO

PURPOSE: Inefficiencies in the clinical trial infrastructure result in protracted trial completion timelines, physician-investigator turnover, and a shrinking skilled labor force and present obstacles to research participation. Taken together, these barriers hinder scientific progress. Technological solutions to improve clinical trial efficiency have emerged, yet adoption remains slow because of concerns with cost, regulatory compliance, and implementation. METHODS: A prospective pilot study that compared regulatory-compliant digital and traditional wet ink paper signatures was conducted over a 6.5-month period in a hospital-based health system. Staff time and effort, error rate, costs, and time to completion were measured. Wilcoxon rank sum tests were used to compare staff time and time to completion. A value analysis was conducted. A survey was administered to measure user satisfaction. RESULTS: There where 96 participants (47 digital, 49 paper), 132 studies included (31 digital, 101 paper), and 265 documents processed (156 digital, 109 paper). A moderate reduction in staff time required to prepare documents for signature was observed (P < .0001). Error rates were reported in 5.1% of digital and 2.8% of paper documents, but this difference was not significant. Discrepancies requiring revisions included incomplete mandatory fields, inaccurate information submitted, and technical issues. A value analysis demonstrated a 19% labor savings with the use of digital signatures. Survey response rate was 57.4% (n = 27). Most participants (85.2%) preferred digital signatures. The time to complete documents was faster with digital signatures compared with paper (P = .0241). CONCLUSION: The use of digital signatures resulted in a decrease in document completion time and regulatory burden as represented by staff hours. Additional cost and time savings and information liquidity could be realized by integrating digital signatures and electronic document management systems.


Assuntos
Neoplasias , Estudos de Viabilidade , Humanos , Projetos Piloto , Estudos Prospectivos , Inquéritos e Questionários
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