Table 1. Indicators of structure in the conduction of multicentre oncology clinical trials in primary care institutions. Villa Clara province, 2010–2020
IndicatorsStructure indicators
2010–2015 periodClinical trial IIC RD-EC120Evaluation2016–2020 periodClinical trial IIC RD-EC-157Evaluation
1. Percentage of polyclinics conditioned to conduct clinical trials in the province 33% (6/18)(6 clinical trial consultations, 6 locals for product administration, 6 pharmacies, 6 laboratories)Certification of compliance of good clinical practices (GCP) Not adequate(<90%) 94% (17/18)(17 clinical trial consultations, 17 locals for product administration, 17 pharmacies, 17 laboratories)Certification of compliance of GCP Adequate(>90%)
2. Percentage of municipalities participating in the clinical trials programme 7.6% (1/13) Not adequate(<90%) 92% (12/13) Adequate(>90%)
3. Percentage of completed investigation teams 33% (6/18) clinical research teams composed of: 6 primary care physicians, 6 nurses, 6 pharmacists, 6 specialists in laboratory, 6 psychologists Not adequate(<90%) 94% (17/18) clinical research teams composed of: 17 primary care physicians, 17 nurses, 17 pharmacist, 17 specialists in laboratory, 17 psychologists Adequate(>90%)
4. Percentage of professionals and technicians trained in clinical trials and oncology 100% (337/337)Courses on GCPs, adverse events, pharmacy, clinical laboratory, nursing83 primary care practitioners trained in oncology (37 general doctors, 37 nurses, and 9 other professionals) Adequate(100%) 100% (373/373)Courses (GCP, adverse events, pharmacy, clinical laboratory, nursing) Adequate(100%)
5. Percentage of polyclinics with electronic data management 0%(Paper data collection) Not adequate(<100%) 100% (17/17)(Training and certification of 68 users) Adequate(100%)
6. Percentage of polyclinics with standard operating procedures (SOPs) implemented 0%(SOPs designed for hospitals was used) Not adequate(<100%) 100% (17/17)(SOPs designed for primary health care centres) Adequate(100%)