2012
DOI: 10.1016/j.jns.2011.10.004
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Implementing clinical trials on an international platform: Challenges and perspectives

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Cited by 44 publications
(31 citation statements)
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“…Contract and budget negotiations between clinical sites and sponsors can take months to negotiate and execute. In a global trial conducted at 57 centers in 16 countries, contract executions spanned an average of 7.9 months for US sites (range 2.5–17.2 months) and 8.7 months for sites outside the US (range 2.5–24.9 months) [ 22 ]. Contributors to prolonged contract and budget cycle times include inexperienced staff, inadequate budget templates, limited negotiation parameters, and prolonged legal reviews [ 19 ].…”
Section: Resultsmentioning
confidence: 99%
“…Contract and budget negotiations between clinical sites and sponsors can take months to negotiate and execute. In a global trial conducted at 57 centers in 16 countries, contract executions spanned an average of 7.9 months for US sites (range 2.5–17.2 months) and 8.7 months for sites outside the US (range 2.5–24.9 months) [ 22 ]. Contributors to prolonged contract and budget cycle times include inexperienced staff, inadequate budget templates, limited negotiation parameters, and prolonged legal reviews [ 19 ].…”
Section: Resultsmentioning
confidence: 99%
“…International trials present unique challenges and benefits [6]. Although they have the potential to increase recruitment and provide generalizable data, international trials are also burdened by increased regulatory burden, data quality, safety monitoring and language barriers [30][31][32][33]. The PARITY trial demonstrated that international sites outside of North America took significantly longer to achieve regulatory approval.…”
Section: Discussionmentioning
confidence: 99%
“…A well executed clinical study may provide the facts needed to change clinical practice and create guidelines for patient management with improvement in patient care are the possible keys in drug development [43]. In recent times, the importance of conducting medical research on a global platform cannot be exaggerated [44].…”
Section: Phase IV Clinical Trialsmentioning
confidence: 99%