Abstract
Background The Centre of Molecular Immunology of Cuba has developed a programme for the conduction of multicenter oncology clinical trials in primary health care 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
Conclusions 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.
- Received September 6, 2021.
- Revision received December 6, 2021.
- Accepted December 13, 2021.
- Copyright © 2022, The Authors
This article is Open Access: CC BY license (https://creativecommons.org/licenses/by/4.0/)