| 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 daysaModification 01: 29 daysa | Protocol Ethical aproval: 22 daysaModification 01: 4 daysaModification 04: 12 daysa | |
| 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) | 6.5a(183/28) | 2.6b(127/48) | 4.0a(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 Percentage of randomised participants who have withdrawn consent to continue in the study | 10.3%(3/29) | 9.2%a(17/183) | 10.2%a13/127) | 9.6%a30/310 |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.