Description of the Protocols for Randomized Controlled Trials on Cancer Drugs Conducted in Spain (1999-2003)
Bonfill, X. (Xavier) (Universitat Autònoma de Barcelona. Departament de Pediatria, d'Obstetrícia i Ginecologia i de Medicina Preventiva)
Ballesteros Silva, Mónica Patricia (Institut d'Investigació Biomèdica Sant Pau)
Gich, Ignasi (Universitat Autònoma de Barcelona. Departament de Pediatria, d'Obstetrícia i Ginecologia i de Medicina Preventiva)
Serrano, María Antonia (Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain)
García López, Fernando (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Urrútia, Gerard (Institut d'Investigació Biomèdica Sant Pau)

Data:	2013
Resum:	To describe the characteristics of randomized controlled clinical trials (RCT) on cancer drugs conducted in Spain between 1999 and 2003 based on their protocols. We conducted an observational retrospective cohort study to identify the protocols of RCTs on cancer drugs authorized by the Agencia Española del Medicamento y Productos Sanitarios (AEMPS) (Spanish Agency for Medicines and Medical Devices) during 1999-2003. A descriptive analysis was completed and the association between variables based on the study setting and sponsorship were assessed. We identified a total of 303 protocols, which included 176,835 potentially eligible patients. Three-quarter of the studies were internationally-based, 61. 7% were phase III, and 76. 2% were sponsored by pharmaceutical companies. The most frequently assessed outcomes were response rate (24. 7%), overall survival (20. 7%), and progression-free survival (14. 5%). Of all protocols, 10. 6% intended to include more than 1000 patients (mean: 2442, SD: 2724). Compared with their national counterparts, internationally-based studies were significantly larger (p<0. 001) and were more likely to implement centralized randomization (p<0. 001), blinding of the intervention (p<0. 001), and survival as primary outcome (p<0. 001). Additionally, most internationally-based studies were sponsored by pharmaceutical companies (p<0. 01). In a high percentage of protocols, the available information was not explicit enough to assess the validity of each trial. Compared to other European countries, the proportion of Spanish cancer drugs protocols registered at (7%) was lower. RCTs on cancer drugs conducted in Spain between 1999 and 2003 were more likely to be promoted by pharmaceutical companies rather than by non-profit national groups. The former were more often part of international studies, which generally had better methodological quality than national ones. There are some worldwide on-going initiatives that aim to increase the transparency and quality of future research.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	PloS one, Vol. 8 (november 2013) , ISSN 1932-6203

DOI: 10.1371/journal.pone.0079684
PMID: 24236154

6 p, 153.2 KB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut de Recerca Sant Pau
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