During 2006 eight hospitals in Spain participated in a multinational, multicenter randomized clinical trial sponso-red by GSK1 to test a vaccine for avian flu. The time to appro-val for the initial trial in Spain, which involved three hospitals in Madrid and two in Barcelona, was shortened substanti...
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| Format: | Text |
| Language: | English |
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| Online Access: | http://citeseerx.ist.psu.edu/viewdoc/summary?doi=10.1.1.484.8652 http://www.tremedica.org/panacea/IndiceGeneral/n27_editorial-shashok.pdf |
| Summary: | During 2006 eight hospitals in Spain participated in a multinational, multicenter randomized clinical trial sponso-red by GSK1 to test a vaccine for avian flu. The time to appro-val for the initial trial in Spain, which involved three hospitals in Madrid and two in Barcelona, was shortened substantially by skipping some steps in the approval process.2 The Spanish drug regulatory agency (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) and participating centers’ clinical trials ethics committees (comités éticos de investi-gación clínica) agreed to the abbreviated process because obtaining an avian flu vaccine was considered a high public health priority at the time. One way in which the time to approval was shortened was by skipping translation into Spanish of the trial protocol. Only the protocol summary, the application to the AEMPS (the competent authority), and the informed consent form were translated into Spanish. The AEMPS agreed to issue its decision within 3 weeks from receipt of the application, and allowed the protocol to be submitted in English only as long as each participating center’s clinical trials ethics committee agreed to consider the application based on the protocol in English rather than Spanish. Although seemingly a departure from the spirit of Direc-tive 2001/20/EC of the European Parliament and Council of 4 April 2001 (on the implementation of good clinical practice in the conduct of clinical trials on medical products for hu-man use),3 this abbreviated procedure appears to comply with current Spanish law regarding clinical trials,4 since the law itself does not explicitly require translation of the protocol into Spanish.5, 6 However, clinical trials ethics committees at hospitals in Spain often require translation of the protocol and investigator’s brochure into Spanish; policies vary from center to center. Postings during April 2007 to the MedTrad email listserve in response to news about the decision to dispense with trans-lation of the protocol into the local language ... |
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