Table 1.
Characteristics of clinical trials approved by KFDA between 2012 and 2013
| Classifying clinical trial | SITs (n=226) | IITs (n=118) | Total (n= 344) | |
|---|---|---|---|---|
| Researchers behavior | Interventional study | 225 | 117 | 342 (99.4) |
| Observational study | 1 | 1 | 2 (0.6) | |
| Participating Institute | Single center study | 48 | 65 | 113 (32.8) |
| Multicenter study | 178 | 53 | 231 (67.2) | |
| Purpose | Chemotherapeutic study | 214 | 105 | 319 (92.7) |
| Cancer diagnostic study | 0 | 4 | 4 (1.2) | |
| Supportive study | 12 | 9 | 21 (6.1) | |
| Phase | Phase 1 | 69 | 11 | 80 (23.3) |
| Phase 2 | 67 | 72 | 139 (40.4) | |
| Phase 3 | 85 | 23 | 108 (31.4) | |
| Phase 4 or PMS | 4 | 3 | 7 (2.0) | |
| Translational research | 0 | 3 | 3 (0.9) | |
| Others | 1 | 6 | 7 (2.0) | |
| Study method | Single group study | 96 | 81 | 177 (51.5) |
| Parallel study | 130 | 37 | 167 (48.5) | |
| Masking | Open study | 157 | 111 | 268 (77.9) |
| Single blind study | 2 | 1 | 3 (0.9) | |
| Double blind study | 67 | 6 | 73 (21.2) | |
| Allocation | Single arm study | 96 | 82 | 178 (51.7) |
| Randomized controlled trial study | 129 | 35 | 164 (47.7) | |
| Non-randomized trial study | 1 | 1 | 2 (0.6) | |
| Direction and timing | Prospective study | 225 | 118 | 343 (99.7) |
| Retrospective study | 1 | 0 | 1 (0.3) | |
| Characteristics of intervention | Drug | 218 | 95 | 313 (91.0) |
| Equipment | 0 | 5 | 5 (1.5) | |
| Biologic agent and vaccine | 8 | 13 | 21 (6.1) | |
| Radiotherapy | 0 | 3 | 3 (0.9) | |
| Genetic test | 0 | 2 | 2 (0.6) | |
| Site of cancer | Lung | 41 | 16 | 57 (16.6) |
| Breast | 31 | 13 | 44 (12.8) | |
| Stomach | 18 | 13 | 31(9.0) | |
| Colorectal | 4 | 4 | 8 (2.3) | |
| Gynecology | 8 | 10 | 18 (5.2) | |
| Genitourinary tract | 12 | 7 | 19 (5.5) | |
| Hematology | 19 | 3 | 22 (6.4) | |
| Lymphoma | 26 | 15 | 41 (11.9) | |
| Multiple myeloma | 9 | 4 | 13 (3.8) | |
| Heptobilliary-pancreas | 19 | 11 | 30 (8.7) | |
| Esophagus | 1 | 3 | 4 (1.2) | |
| Head and neck | 2 | 3 | 5 (1.5) | |
| Others | 36 | 16 | 52 (15.1) |
Values are presented as number (%). KFDA, Korea Food and Drug Administration; SITs, sponsor-initiated clinical trials; IITs, investigator-initiated clinical trials; PMS, postmarketing survey.