Elisa Gobbini1, Sara Pilotto2, Giulia Pasello3, Valentina Polo3, Massimo Di Maio4, Francesca Arizio1, Domenico Galetta5, Patrizia Petrillo5, Rita Chiari6, Roberta Matocci6, Alessandro Di Costanzo7, Teresa Severina Di Stefano7, Massimo Aglietta8, Celeste Cagnazzo8, Isabella Sperduti9, Emilio Bria10, Silvia Novello1. 1. Department of Oncology, University of Turin, Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano, Italy. 2. Department of Medical Oncology, University of Verona, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy. Electronic address: sara.pilotto@univr.it. 3. Department of Medical Oncology 2, Istituto Oncologico Veneto IRCCS, Padua, Italy. 4. Department of Oncology, University of Turin, Mauriziano Hospital, Turin, Italy. 5. Oncology Unit, Clinical Cancer Center, "Giovanni Paolo II", Bari, Italy. 6. Oncology Unit, "Santa Maria della Misericordia" Hospital, Perugia, Italy. 7. Oncology Unit, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy. 8. Oncology Unit, Candiolo Institute IRCCS, Candiolo, Italy. 9. Department of Biostatistics, Regina Elena National Cancer Institute, Rome, Italy. 10. Department of Medical Oncology, University of Verona, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy.
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 AND METHODS: 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.
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 AND METHODS: 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.
Authors: Jose Luis Perez-Gracia; Ahmad Awada; Emiliano Calvo; Teresa Amaral; Hendrik-Tobias Arkenau; Viktor Gruenwald; Gyorgy Bodoky; Martijn P Lolkema; Massimo Di Nicola; Nicolas Penel; Ruth Vera; Miguel F Sanmamed; Jean-Yves Douillard Journal: ESMO Open Date: 2020-05