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- Title
Effect of Contract Research Organization Bureaucracy in Clinical Trial Management: A Model From Lung Cancer.
- Authors
Gobbini, Elisa; Pilotto, Sara; Pasello, Giulia; Polo, Valentina; Di Maio, Massimo; Arizio, Francesca; Galetta, Domenico; Petrillo, Patrizia; Chiari, Rita; Matocci, Roberta; Di Costanzo, Alessandro; Di Stefano, Teresa Severina; Aglietta, Massimo; Cagnazzo, Celeste; Sperduti, Isabella; Bria, Emilio; Novello, Silvia
- Abstract
<bold>Introduction: </bold>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.<bold>Materials and Methods: </bold>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.<bold>Results: </bold>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).<bold>Conclusion: </bold>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.
- Subjects
ITALY; ASSOCIATIONS, institutions, etc.; COMPARATIVE studies; CONTRACTING out; ENDOWMENT of research; LUNG tumors; RESEARCH methodology; MEDICAL cooperation; ONCOLOGY; RESEARCH; SODIUM compounds; FINANCIAL management; EVALUATION research; RETROSPECTIVE studies; ECONOMICS
- Publication
Clinical Lung Cancer, 2018, Vol 19, Issue 2, p191
- ISSN
1525-7304
- Publication type
journal article
- DOI
10.1016/j.cllc.2017.10.012