Implementation of oncological clinical trials in primary health care in Cuba: a program generalization study.

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.