Effect of Contract Research Organization Bureaucracy in Clinical Trial Management: A Model From Lung Cancer.
Clin Lung Cancer
; 19(2): 191-198, 2018 03.
Article
em En
| MEDLINE
| ID: mdl-29153968
ABSTRACT
INTRODUCTION:
Contract research organization (CRO) support is largely included in clinical trial management, although its effect in terms of time savings and benefit has not yet been quantified. We performed a retrospective multicenter analysis of lung cancer trials to explore differences in term of trial activation timelines and accrual for studies with and without CRO involvement. MATERIALS ANDMETHODS:
Results regarding study timelines from feasibility data to first patient enrollment were collected from 7 Italian thoracic oncology departments. The final accruals (screened/enrolled patients) are reported. We considered CRO/sponsor-administered and CRO-free trials according to who was responsible for the management of the crucial setup phases.RESULTS:
Of 113 trials, 62 (54.9%) were CRO-administered, 34 (30.1%) were sponsor-administered, and 17 (15.0%) were CRO-free. The median time from feasibility invitation to documentation obtainment was 151 days in the CRO-administered trials versus 128 in the sponsor-administered and 120 in the CRO-free trials. The time from document submission to contract signature was 142 days in the CRO-administered versus 128 in the sponsor-administered and 132 in the CRO-free trials. The time from global accrual opening to first patient enrollment was 247 days for the CRO-administered versus 194 in the sponsor-administered and 151 in the CRO-free trials. No significant differences were observed in terms of the median overall timeline 21 months in the CRO-administered, 15 in the sponsor-administered, and 18 months in the CRO-free studies (P = .29).CONCLUSION:
Although no statistically significant differences were identified, the results of our analysis support the idea that bureaucratic procedures might require more time in CRO-administered trials than in sponsor-administered and CRO-free studies. This bureaucratic delay could negatively affect Italian patients' screening and enrollment compared with other countries.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Fluoreto de Sódio
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Uretana
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Serviços Contratados
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Academias e Institutos
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Neoplasias Pulmonares
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Oncologia
Idioma:
En
Ano de publicação:
2018
Tipo de documento:
Article