Table 2.
Characteristics of registered interventional trials
| Characteristic | Period 1, n/N (%) | Period 2, n/N (%) | Period 3, n/N (%) | Total, n/N (%) |
|---|---|---|---|---|
| Period total | 817 | 3926 | 5742 | 10485 |
| Type of primary sponsor | ||||
| Pharmaceutical industry | 577/773 (74.6) | 1115/3910 (28.5) | 577/5742 (10.0) | 2269/10425 (21.8) |
| Government funding* | 105/773 (13.6) | 1775/3910 (45.4) | 3088/5742 (53.7) | 4968/10425 (47.7) |
| Private medical colleges/hospitals | 21/773 (2.7) | 255/3910 (6.5) | 560/5742 (9.7) | 836/10425 (8.0) |
| Other (including PI-initiated studies) | 70/773 (9.1) | 765/3910 (19.6) | 1517/5742 (26.4) | 2352/10425 (22.6) |
| Missing data** | 44/817 (5.4) | 16/3926 (0.4) | 0/5742 (0.0) | 60/10485 (0.6) |
| Countries of recruitment | ||||
| Multicountry (including India) | 316/817 (38.6) | 495/3926 (12.6) | 220/5742 (3.8) | 1031/10485 (9.8) |
| Country other than India | 1/817 (0.1) | 7/3926 (0.1) | 18/5742 (0.3) | 26/10485 (0.2) |
| India | 500/817 (61.2) | 3424/3926 (87.2) | 5504/5742 (95.8) | 9428/10485 (89.9) |
| Status of trial*** | ||||
| Prospective registration | Missing data** | 1432/3828 (37.4) | 2391/2391 (41.6) | 3823/9570 (39.9) |
| Retrospective registration | Missing data** | 2376/3828 (62.1) | 3349/2391 (58.3) | 5725/9570 (59.8) |
| Terminated trial registration | Missing data** | 20/3828 (0.5) | 2/2391 (0.0) | 22/9570 (0.2) |
| Missing data** | 817/817 (100.0) | 98/3926 (2.5) | 0/5742 (0.0) | 915/10485 (8.7) |
| Type of trial | ||||
| Drug | 584/817 (71.5) | 1717/3926 (43.7) | 2086/5742 (36.3) | 4387/10485 (32.7) |
| Vaccine | 60/817 (7.3) | 131/3926 (3.3) | 68/5742 (1.2) | 259/10485 (1.9) |
| Biological | 63/817 (7.7) | 193/3926 (4.9) | 137/5742 (2.4) | 393/10485 (2.9) |
| Nutraceutical | 29/817 (3.5) | 183/3926 (4.7) | 185/5742 (3.2) | 397/10485 (2.9) |
| Stem cell therapy | 16/817 (2.0) | 20/3926 (0.5) | 8/5742 (0.1) | 44/10485 (0.3) |
| Medical device | 13/817 (1.6) | 198/3926 (5.0) | 266/5742 (4.6) | 477/10485 (3.5) |
| Traditional medicinal systems | 24/817 (2.9) | 692/3926 (17.6) | 1453/5742 (25.3) | 2169/10485 (16.2) |
| Procedures | 39/817 (4.8) | 757/3926 (19.3) | 1608/5742 (28.0) | 2404/10485 (17.9) |
| Radiation therapy | 5/817 (0.6) | 37/3926 (0.9) | 64/5742 (1.1) | 106/10485 (0.7) |
| Diagnostic | 3/817 (0.4) | 63/3926 (1.6) | 86/5742 (1.5) | 152/10485 (1.1) |
| Preventive | 16/817 (2.0) | 190/3926 (4.8) | 280/5742 (4.9) | 486/10485 (3.6) |
| Screening | 1/817 (0.1) | 28/3926 (0.7) | 69/5742 (1.2) | 98/10485 (0.7) |
| Dentistry | 6/817 (0.7) | 131/3926 (3.3) | 520/5742 (9.1) | 657/10485 (4.9) |
| Behavioral | 3/817 (0.4) | 94/3926 (2.4) | 212/5742 (3.7) | 309/10485 (2.2) |
| Others | 28/817 (3.4) | 410/3926 (10.4) | 613/5742 (10.7) | 1051/10485 (7.8) |
| Phase of trial | ||||
| Phase 1 | 41/817 (5.0) | 108/3926 (2.7) | 306/5742 (5.3) | 455/10485 (4.3) |
| Phase 1/Phase 2 | 20/817 (2.4) | 107/3926 (2.7) | 210/5742 (3.6) | 337/10485 (3.2) |
| Phase 2 | 131/817 (16.0) | 534/3926 (13.6) | 724/5742 (12.6) | 1389/10485 (13.2) |
| Phase 2/Phase 3 | 35/817 (4.2) | 145/3926 (3.6) | 293/5742 (5.1) | 473/10485 (4.5) |
| Phase 3 | 427/817 (52.2) | 857/3926 (21.8) | 633/5742 (11.0) | 1917/10485 (18.2) |
| Phase 3/Phase 4 | 13/817 (1.5) | 109/3926 (2.7) | 143/5742 (2.4) | 265/10485 (2.5) |
| Phase 4 | 79/817 (9.6) | 531/3926 (13.5) | 515/5742 (8.9) | 1125/10485 (10.7) |
| Phase not applicable | 71/817 (8.6) | 1474/3926 (37.4) | 2736/5742 (47.6) | 4281/10485 (40.8) |
| Postmarketing surveillance | 0 (0.0) | 61/3926 (1.5) | 182/5742 (3.1) | 243/10485 (2.3) |
| Study Design | ||||
| Single arm trial | 92/817 (11.2) | 631/3926 (16.0) | 868/5742 (15.1) | 1591/10485 (15.1) |
| NonRandomized | 19/817 (2.3) | 159/3926 (4.0) | 224/5742 (3.9) | 402/10485 (3.8) |
| Randomized | 646/817 (79.0) | 2798/3926 (71.2) | 4182/5742 (72.8) | 7626/10485 (72.7) |
| Other | 60/817 (7.3) | 338/3926 (8.6) | 468/5742 (8.1) | 866/10485 (8.2) |
| Blinding | ||||
| Open label | 258/817 (31.5) | 1132/3865 (29.3) | 1518/5648 (26.9) | 2908/10330 (28.2) |
| Single blinded | 66/817 (8.0) | 479/3865 (12.4) | 1061/5648 (18.8) | 1606/10330 (15.5) |
| Double blinded | 61/817 (7.4) | 817/3865 (21.1) | 1215/5648 (21.5) | 2093/10330 (20.3) |
| Triple blinded | 187/817 (22.8) | 291/3865 (7.5) | 307/5648 (5.4) | 785/10330 (7.6) |
| Quadruple blinded | 157/817 (19.2) | 246/3865 (6.4) | 200/5648 (3.5) | 603/10330 (5.8) |
| Not applicable | 88/817 (10.7) | 900/3865 (23.3) | 1347/5648 (23.8) | 2335/10330 (22.6) |
| Not available# | 0/817 (0.0) | 61/3926 (1.5) | 94/5742 (1.6) | 155/10485 (1.5) |
*Including medical colleges, research institutes and hospitals, **Missing Data: The CTRI software was upgraded in March 2011 with additional drop-down lists. Trials registered prior to this period but not updated despite repeated requests are indicated as missing data and is variable for individual evaluated characteristic. Percentages have been calculated after excluding missing data, ***As per flagging of trial and as per recruitment status of study at the time of registration which was introduced in March 2011, #Not Available: No information has been provided by the registrant as this is not a mandatory field. Period 1=Time period between July 20, 2007 and December 31,2010; Period 2=Time period between January 1, 2011 and December 31, 2015, Period 3: Time period between January 1, 2016 and May 31, 2018, CTRI=Clinical Trials Registry - India