Multicentre oncology clinical trials in primary health care in Cuba: evaluation of programme implementation in Villa Clara Province, 2010-2020.

Autor:	Lorenzo G; Center of Molecular Immunology, Havana, Cuba geydi@cim.sld.cu., Ortiz RA; 'Celestino Hernández Robau' Hospital, Villa Clara, Cuba., Méndez R; National Coordinating Centre of Clinical Trials, Villa Clara, Cuba., Rodríguez M; National Coordinating Centre of Clinical Trials, Villa Clara, Cuba., Marrero R; National Coordinating Centre of Clinical Trials, Villa Clara, Cuba., de la Barca NDC; Chiqui Gómez Polyclinic, Vila Clara, Cuba., Granela MC; Roberto Fleites Polyclinic, Villa Clara, Cuba., Artiles M; XX Aniversario Polyclinic, Villa Clara, Cuba., Norvel M; Marta Abreu Polyclinic, Villa Clara, Cuba., Cepeda M; Center of Molecular Immunology, Havana, Cuba., Toledo E; Celestino Hernández Hospital, Villa Clara, Cuba., González A; Celestino Hernández Hospital, Villa Clara, Cuba., Crespo JC; Celestino Hernández Hospital, Villa Clara, Cuba., Torres O; Center of Molecular Immunology, Havana, Cuba., Nieto L; Central University of Las Villas, Villa Clara, Cuba., Crombet T; Center of Molecular Immunology, Havana, Cuba., Sánchez L; Center of Molecular Immunology, Havana, Cuba., Lage A; Center of Molecular Immunology, Havana, Cuba.
Jazyk:	angličtina
Zdroj:	BJGP open [BJGP Open] 2022 Sep 28; Vol. 6 (3). Date of Electronic Publication: 2022 Sep 28 (Print Publication: 2022).
DOI:	10.3399/BJGPO.2021.0165
Abstrakt:	Background: The Center of Molecular Immunology of Cuba has developed a programme for the conducting of multicentre oncology clinical trials in primary healthcare centres since 2009. Aim: To evaluate the ability to conduct oncology clinical trials in primary health care. Design & Setting: A longitudinal, prospective, analytical study was developed between July 2010 and August 2020 in the Villa Clara province. Method: Structure, process, and outcome indicators were evaluated by the methods of a structured interview, direct observation, documentary observation, and databases analysis. The investigators' curricula vitae, the investigator site file, minutes of workshops, the monitoring reports, the clinical trial training records, and databases were employed as sources of information. The following criteria were considered adequate: when the indicator met the standard; and not adequate: when the indicator did not meet the standard. Results: The six structure indicators reached adequate results and showed that the programme has allowed building of capacities to conduct clinical trials in primary care. The eight processes indicators and two outcome indicators were considered adequate too. Trials conducted in primary care showed better indicators of patient recruitment than secondary care. Both scenarios showed similar behaviour for the process indicators: retention, protocol compliance, and safety. Survival and satisfaction with health services were also comparable in both scenarios. Conclusion: The evaluation of the programme showed adequate indicators for conducting oncology clinical trials in primary care in Villa Clara and these were comparable to those determined in the secondary care. (Copyright © 2022, The Authors.)
Databáze:	MEDLINE
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