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Vol. 147. Issue 2.
Pages 76-80 (July 2016)
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Vol. 147. Issue 2.
Pages 76-80 (July 2016)
Special article
When the information provided to participants of a comparative effectiveness trial ends up in the court: The opening of Pandora's box?
Cuando la información para los participantes de un ensayo de efectividad comparativa acaba en los tribunales: ¿se abre la caja de Pandora?
a Investigación Clínica, Programa BUC (Biociencias UAN+CSIC), Centro de Excelencia Internacional, Universidad Autónoma de Madrid, Madrid, Spain
b Servicio de Neonatología, Departamento de Pediatría, Hospital Universitario La Paz, Facultad de Medicina, Universidad Autónoma de Madrid, Madrid, Spain
c Departamento de Medicina Preventiva, Salud Pública e Historia de la Ciencia, Universidad Complutense, Madrid, Spain
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Tables (4)
Table 2. Patient information leaflet for the SUPPORT trial participant. Deficiencies reported by Public Citizen in a letter to the U.S. Department of Health and Human Services, in May 2013.
Table 3. Interpretation of the American regulations regarding the information on reasonably expected risks in comparative effectiveness studies by OHRP.
Table 4. Obtaining an informed consent in efficacy clinical trials and in comparative effectiveness clinical trials.
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