Abstract / Summary
Background: Primary health care (PHC) offers a strategic opportunity to conduct research with immunotherapeutic products for cancer treatment. Objectives: To evaluate the implementation of a program for conducting oncological clinical trials in PHC settings. The implementation objectives focused on assessing structure, process, and outcome indicators against predefined standards; the intervention objectives compared process and clinical outcomes (overall survival, quality of life, and patient satisfaction) in PHC settings against a historical control from secondary care. Methods: A longitudinal, prospective, analytical implementation study was conducted in Cuba between January 2016 and August 2023. An open-label, uncontrolled, non-randomized, multicenter, phase IV clinical trial using the CIMAvax-EGF vaccine for patients with advanced lung cancer was used as a case study. The implementation was conducted in three phases: pilot study, replication, and generalization. This paper presents the outcomes of the generalization phase. For evaluation, structure, process, and outcome indicators were assessed against predefined standards and compared with a historical control from secondary health care (SHC). An indicator was considered adequate if it met the standard. The overall dimension (structure, process, or outcome) was considered acceptable if ≥ 70% of its indicators were adequate. Results: The program was implemented in 119 polyclinics nationwide. For structure, 83% (5/6) of indicators were adequate; for process, 83% (5/6) were adequate; for outcome, 100% (4/4) were adequate. All three dimensions met the predefined standards. Process and outcome indicators were comparable or superior to the SHC historical control. Structure and outcome indicators improved after implementation. Conclusions: The results support the feasibility and effectiveness of implementing oncological clinical trials in Cuban PHC centers, demonstrating a positive impact on the target population.