Añorve Bailon, Denisse http://orcid.org/0000-0002-2019-9219
Picó-Guzmán, Javier http://orcid.org/0000-0003-1555-0841
Cifuentes, Sergio
Trejo, Rogelio
Rodríguez Cid, Jeronimo http://orcid.org/0000-0001-8518-9065
Juarez-Vignon Whaley, Juan Jose http://orcid.org/0000-0001-5570-2147
Heredia Zepeda, Alan Alexis
Gerson, Raquel
Camacho-Limas, Christian Patricio
Martínez-Herrera, José Fabián http://orcid.org/0000-0001-9894-2204
Molina, Diana Bonilla http://orcid.org/0000-0002-0435-3247
Camarín Sánchez, Efraín http://orcid.org/0000-0002-6672-5018
Shveid Gerson, Daniela http://orcid.org/0000-0002-9501-3060
Funding for this research was provided by:
Amgen México
Article History
Accepted: 18 July 2024
First Online: 6 August 2024
Declarations
:
: This study was sponsored by Amgen Inc.
: Amgen sponsored the current investigation and engaged Lifesciences Consultants (LSC) to oversee and independently conduct the research with each participating center. LSC established collaboration terms with each healthcare facility, primarily focusing on compensating for the time required to collect and curate patient data, as well as effectively managing the study protocol. It is important to note that the compensation provided was not linked to any specific data outcomes. Denisse Añorve Bailon, Javier Picó-Guzmán, Sergio Cifuentes, Rogelio Trejo, Jeronimo Rodríguez Cid, Juan Jose Juarez-Vignon Whaley, Alan Alexis Heredia Zepeda, Raquel Gerson, Christian Patricio Camacho-Limas, José Fabián Martínez-Herrera, Diana Bonilla Molina, Efraín Camarín Sánchez, and Daniela Shveid Gerson have no relevant financial or non-financial interests to disclose.
: The data from this study, sourced under the authorization of an Ethics and Investigation Committee’s protocol within each healthcare center, are confidential and are not accessible in public databases; however, the data underpinning this study’s findings are available from the corresponding author upon reasonable request. Multiple healthcare institutions contributed to the data collection, each endorsing a specific protocol to authorize data sharing. Researchers from these institutions were tasked with data acquisition. To ensure patient privacy, all data were anonymized, with any potentially identifying information excised before distribution. Inquiries regarding data access can be directed to the corresponding author and will be considered in line with institutional policies and relevant regulatory standards.
: In the interest of preserving the integrity of the ethics involved in this retrospective study, we ensured that each participating center adhered to a meticulously devised research protocol. This protocol was scrupulously reviewed and approved by the respective Ethics and Investigation Committees in each center. The ‘Descripción de la carga clínica, económica y social de la situación nacional de cáncer de pulmón de células no pequeñas’ protocol was approved by the INER with the No. N/A; the ‘Estudio retrospectivo, descriptivo longitudinal y analítico no comparativo del manejo clínico de pacientes con cáncer de pulmón de células no pequeñas en estadios IIIB y IV para la estimación del impacto económico institucional y social en el Centro Médico Nacional “20 de Noviembre”’ protocol was approved by the ISSTE with the No. 502.2022; the ‘Caracterización molecular y resultados del tratamiento de pacientes con diagnóstico de adenocarcinoma pulmonar Etapa IV en dos hospitales de referencia en México: estudio de cohorte retrospectiva’ protocol was approved by IMSS with the No. 2021-785-006; and the Medical Center ABC (American British Cowdray) approved the protocol ‘Estudio retrospectivo, descriptivo longitudinal y analítico no comparativo del tratamiento y seguimiento clínico de pacientes con cáncer de pulmón de células no pequeñas en estadios IIIB y IV para la estimación del impacto económico institucional y social en el Centro Médico ABC de la Ciudad de México’ with the No. ABC-22-25. The protocols adhere to the international codes and standards in force with good clinical practice research guidelines, subject to the considerations of the Declaration of Helsinki – Ethical Principles for Medical Research on Human Beings, of the 64th General Assembly of the World Medical Association, of the General Health Law on health research, Articles 96–102. According to article 17 of the same General Health Law, it is verified that there is no risk whatsoever for the patient on whom the research is being carried out since we will carry out a retrospective study, where we will not obtain a sample of any bodily fluid, nor administration of drugs.
: Prior to data acquisition, we secured all necessary approvals and authorizations, diligently maintaining comprehensive records of these approvals in the form of authorization letters, readily available for presentation upon request. It is important to note that patient consent was not required for this study as the study was purely observational and retrospective. Consequently, the study had no impact on patient management, and all data were anonymized before being analyzed and aggregated. This approach ensured the integrity of the research and the privacy of the individuals involved.
: Not applicable since the personal data of all patients were not retrieved during the analysis. Only clinical data were retrieved and, under a patient ID number, were untraceable to any patient.
: Not applicable.
: DAB, SC, and AAHZ conducted the formal analysis, curated the data, and reviewed and edited the manuscript. As corresponding author, JPG also oversaw the methodology, project administration, and supervision. RT, JRC, JJJVW, DBM, ECS, and DSG focused on data curation. RG, CPCL, and JFMH contributed to manuscript review and editing. AAHZ prepared the original draft. All authors have read and approved the final version of the manuscript. It is noteworthy to mention that no external medical writing support was required in preparing this manuscript. Each author contributed to the writing, editing, and formatting of the manuscript based on their individual expertise, and all changes were authorized by each of the listed authors.