Effect of Contract Research Organization Bureaucracy in Clinical Trial Management: A Model From Lung Cancer

• Published in: Clinical lung cancer 2018-03, Vol.19 (2), p.191-198
• Main 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
• Format: Article
• Language: English
• Subjects: Academies and Institutes - economics; Academies and Institutes - organization & administration; Bureaucratic procedures; Clinical trials; Clinical Trials as Topic; Contract Services; CRO; Financial Management; Humans; Italy - epidemiology; Lung Neoplasms - epidemiology; Medical Oncology - economics; Medical Oncology - organization & administration; Patient accrual; Research Support as Topic; Retrospective Studies; Sodium Fluoride; Timelines; Urethane - analogs & derivatives
• ISSN: 1525-7304; 1938-0690
• DOI: 10.1016/j.cllc.2017.10.012

Although contract research organization (CRO) support is commonly included in clinical trial management, its hypothetical effect in terms of time savings and benefit has never been quantified. Thus, we retrospectively analyzed 113 lung cancer trials to evaluate the activation timelines and patient accrual according to CRO involvement. The exploratory results of our analysis suggest that bureaucratic procedures might require more time in CRO-administered trials than in sponsor-administered and CRO-free studies, which also result in greater numbers of patient screening and enrollment. 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. 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. 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). 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 oth