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

Geidy Lorenzo; Ramón Alberto Ortiz; Rayza Méndez; Migdalia Rodríguez; Rayza Marrero; Nieves del Carmen de la Barca; María Cecilia Granela; Maritza Artiles; Menelio Norvel; Meylan Cepeda; Elsa Toledo; Alexis González; Juan Carlos Crespo; Olga Torres; Leisy Nieto; Tania Crombet; Liset Sánchez; Agustín Lage

doi:10.3399/BJGPO.2021.0165

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Table 1. Indicators of structure in the conduction of multicentre oncology clinical trials in primary care institutions. Villa Clara province, 2010–2020

Indicators	Structure indicators
Indicators	2010–2015 periodClinical trial IIC RD-EC120	Evaluation	2016–2020 periodClinical trial IIC RD-EC-157	Evaluation
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%)

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Table 2. Process indicators in multicentre oncology clinical trials conducted in primary health care in Villa Clara province. Comparison of primary health care versus secondary health care

	Secondary heath care	Primary health care (clinical trial programme implementation)
	2006–2011 period(phase III, EC IIC-RD-EC081)n = 29	2010–2015 period(phase IV, EC IIC RD-EC120)n = 183	2016–2020 period(phase IV, EC IIC RD-EC-157)n = 127	2010–2020 periodn = 310
Study details	Histological confirmation of NSCLC stage III or IV, Objective Clinical Response after oncospecific treatment, performance status ≤2, life expectancy ≥3 months	Histological confirmation of NSCLC stage III or IV, patients classified as non-tributary of any oncospecific treatment or who have received first line of chemotherapy for the advanced disease and do not have not any therapeutic alternatives, performance status ≤3, life expectancy ≥3 months	Histological confirmation of NSCLC stage III or IV, patients classified as non-tributary of any oncospecific treatment or who have received first line of chemotherapy for the advanced disease and do not have not any therapeutic alternatives, performance status ≤3, life expectancy ≥3 months. Biomarker determination
Ethical approval
7. Time for protocol and protocol modifications ethical approval	Protocol ethical approval:18 daysModification 03: 7 daysModification 04: 16 days	Protocol ethical approval: 28 days^aModification 01: 29 days^a	Protocol Ethical aproval: 22 days^aModification 01: 4 days^aModification 04: 12 days^a
Recruitment and retention
8. Province recruitment versus total trial recruitment	5.8%(29/497)	17.3%^a(183/1058)	17.1%^a(127/741)	17.2%^a(310/1799)
9. Proportion of patients recruited or incidence of disease	2.3%29/1214	27.8%^a183/658	8.6%^b127/1463	14.6%^a310/2121
10. Inclusion rate (patients included per month)	0.36(29/79)	6.5^a(183/28)	2.6^b(127/48)	4.0^a(310/76)
11. Percentage of randomised participants who have withdrawn consent to continue in the study	10.3%(3/29)	9.2%^a(17/183)	10.2%^a13/127)	9.6%^a30/310
Protocol compliance (adherence)
12. Percentage of protocol deviations (non-compliance with treatment scheme)	6.8%(2/29)	4.3%^a(8/183)	7.0%^a(9/127)	5.4%^a(17/310)
Management of adverse events
13. Number of grade 3–4 related adverse events per number of enrolled participants	6.8%(2/29)	2.1%^a(4/183)	1.5%^a(2/127)	1.9%^a6/310
14. Number of serious related adverse events reported per number of enrolled participants	6.8%(2/29)	3.8%^a(7/183)	0.7%^a(1/127)	2.5%^a8/310

Indicator evaluation: ^aadequate, ^bnot adequate. NSCLC = non-small cell lung cancer
Other study details are available at: http://rpcec.sld.cu/trials/RPCEC00000161-En, http://rpcec.sld.cu/trials/RPCEC00000181-En and http://rpcec.sld.cu/trials/RPCEC00000205-En.

Supplementary Data

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