Torregrosa, Mª D. http://orcid.org/0000-0002-1285-1131
,
Escudero, M. J.
Paredero, I. http://orcid.org/0000-0003-3618-8685
Carrasco, E.
Bermejo, B.
Gavila, J.
García-Saenz, J.
Santaballa, A.
Martínez, P.
Llombart, A.
Andrés, R.
Batista, N.
Fernández, A.
Antón, A.
Seguí, M.
Gonzalez, S.
Ruiz, A.
Funding for this research was provided by:
BMS
Roche
Lilly
Novartis
Pfizer
Article History
Received: 20 May 2019
Accepted: 17 July 2019
First Online: 5 August 2019
Compliance with ethical standards
:
: Dr García-Sáenz has received consultancy/speaker fees from Novartis, Celgene, Lilly, EISAI and Roche. Travel support from Novartis, Roche, Pfizer and his institution research funding from AstraZeneca. The rest of authors declared no conflicts of interest.
: Data were collected following the requirements of the Spanish legislation for privacy data protection in the considered period. The information collected by the investigators (doctors and health care personnel) was retrospective information that already existed in the patient’s clinical history. The information collected did not contain any personal data. The specific regulation for observational retrospective studies, like El Álamo, was developed in Spain at 2009 with the ORDER SAS/3470/2009, of December 16th, which publishes guidelines on post-authorization observational studies for drugs for human use. From this moment on, observational retrospective studies have a specific regulation that did not exist before. This is the reason why the IRBs in Spain did not reviewed nor approved any observational retrospective study before this legislation was developed.
: According to regulations in force (Order SAS), the informed consent of the subjects is not required since: 1) in the process of data collection retrospectively, a secure dissociation procedure is adopted, ensuring that the information handled in the study does not contain personal data and 2) personal interviews are not required nor are biological samples collected from patients. Each patient received a number identification of participation in the study and patient’s data confidentiality and compliance with the ethical rules was guaranteed.