Russian clinical research policy does not guarantee results availability

Table 1 Posting the results in clinicaltrials.gov

Study characteristic	Has results	No results available	Total	Percent with the results
Subject age
Child	21	78	99	21.21
Child/adult	6	37	43	13.95
Child/adult/senior	28	117	145	19.31
Adult	17	192	209	8.13
Adult/senior	260	1301	1561	16.66
Senior	3	2	5	60.00
Subject sex
Both	293	1536	1829	16.02
Female	22	131	153	14.38
Male	20	60	80	25.00
Total	335	1727	2062	16.25
Sponsorship
Industry	322	1566	1888	17.06
Industry combined with non-industry sources	12	63	75	16.00
Non industry sponsors	1	98	99	1.01
Examined Interventions
Behavioral	0	9	9	0.00
Biological	14	115	129	10.85
Device	0	17	17	0.00
Dietary supplement	1	3	4	25
Drug	315	1468	1783	17.67
Genetic	0	1	1	0.00
Other	0	22	22	0.00
Procedure	0	31	31	0.00
Radiation	0	1	1	0.00
Phases of clinical trials
Phase 1	1	42	43	2.33
Phase 1/phase 2	3	31	34	8.82
Phase 2	58	429	487	11.91
Phase 2/phase 3	8	43	51	15.69
Phase 3	221	936	1157	19.10
Phase 4	38	133	171	22.22
Recruitment
Active, not recruiting	25	339	364	6.87
Approved for marketing	0	2	2	0.00
Available	0	3	3	0.00
Completed	288	744	1032	27.91
Enrolling by invitation	0	20	20	0.00
No longer available	0	1	1	0.00
Not yet recruiting	0	25	25	0.00
Recruiting	0	481	481	0.00
Suspended	0	3	3	0.00
Temporarily not available	0	1	1	0.00
Terminated	22	100	122	18.03
Interventional	327	1624	1951	16.76
Observational	8	96	104	7.69

Table 2 Publication of the registered studies that enrolled Russian subjects

Study characteristics	Published	Unpublished	Total	Percent published
Age
Adult	26	183	209	12.4
Adult/senior	327	1234	1561	20.9
Child	7	92	99	7.1
Child/adult	3	40	43	7.0
Child/adult/senior	18	127	145	12.4
Senior	2	3	5	40.0
Sex
Both	352	1477	1829	19.2
Female	23	130	153	15.0
Male	8	72	80	10.0
Sponsorship
Industry	354	1534	1888	18.8
Industry/National Institutes of Health	0	2	2	0.0
Industry/other	14	42	56	25.0
Industry/other/ National Institutes of Health	0	1	1	0.0
Industry/United States Fed	1	1	2	50.0
Other/industry	0	13	13	0.0
Other/National Institutes of Health/industry	0	1	1	0.0
National Institutes of Health	4	6	10	40.0
National Institutes of Health/other	0	1	1	0.0
Other	10	70	80	12.5
Other/National Institutes of Health	0	8	8	0.0
Interventions
Behavioral	2	7	9	22.2
Biological	10	119	129	7.8
Device	1	16	17	5.9
Dietary supplement	1	3	4	25.0
Drug	359	1424	1783	20.1
Genetic	0	1	1	0.0
Other	2	20	22	9.1
Procedure	5	26	31	16.1
Radiation	0	1	1	0.0
Phases of clinical trials
Phase 1	0	43	43	0.0
Phase 1/phase 2	3	31	34	8.8
Phase 2	68	419	487	14.0
Phase 2/phase 3	5	46	51	9.8
Phase 3	257	900	1157	22.2
Phase 4	40	131	171	23.4
Recruitment
Active, not recruiting	51	313	364	14.0
Approved for marketing	1	1	2	50.0
Completed	285	747	1032	27.6
No longer available	1	0	1	100
Suspended	0	3	3	0.0
Temporarily not available	0	1	1	0.0
Terminated	23	99	122	18.9
Withdrawn	0	8	8	0.0
Study type
Interventional	375	1576	1951	19.2
Observational	6	98	104	5.8
Posting the results in clinicaltrials.gov
Has results	143	192	335	42.7
No results available	240	1487	1727	13.9

Table 3 Enrollment of the subjects in the registered clinical studies by study characteristics

Study characteristic	Sum	Mean	Std Dev	Median
Subject age
Adult	122622	592	1334	353
Adult/senior	1817056	1181	2836	462
Child	35069	358	891	172
Child/adult	9727	226	335	100
Child/adult/senior	415280	2925	9863	450
Senior	9816	1963	2158	450
Subject sex
Both	2224171	1232	3849	423
Female	132363	877	1388	419
Male	53036	689	1143	300
Sponsorship
Industry	2130061	1142	3628	432
Industry/National Institutes of Health	465	465		465
Industry/other	123747	2250	4293	500
Industry/other/National Institutes of Health	8381	8381		8381
Industry/United States Fed	750	375	318	375
National Institutes of Health	30401	3040	5516	860
National Institutes of Health/other	280	280		280
Other	91308	1201	3831	145
Other/industry	17011	1309	2776	200
Other/National Institutes of Health	4166	521	477	335
Other/National Institutes of Health/ industry	3000	3000		3000
Interventions
Behavioral	23514	2613	5846	400
Biological	116476	917	3958	288
Device	16116	948	2458	90
Dietary supplement	1712	428	605	150
Drug	2058994	1171	3623	448
Genetic	100	100		100
Other	27135	1292	3539	160
Procedure	8566	276	381	150
Phases of clinical trials
Phases = phase 1	2412	56	63	36
Phases = phase 1/phase 2	3690	109	104	98
Phases = phase 2	149238	310	374	200
Phases = phase 2/phase 3	31469	629	960	295
Phases = phase 3	1443064	1267	2773	587
Phases = phase 4	234401	1379	3495	391
Recruitment
Completed	1355817	1331	4549	460
Suspended	792	264	216	210
Terminated	110736	915	2501	284
Withdrawn	540	77	133	0
Study type
Interventional	1845794	956	2415	404
Observational	563776	5421	11639	1069
Posting of the results in clinicaltrials.gov
Study results = has results	524214	1570	4804	484
Study results = no results available	1885356	1109	3381	402
Terminated studies with no results available		102335	1034	2740
Terminated studies with posted results		8401	382	573
Terminated unpublished studies with posted results		3554	209	217
Terminated unpublished studies without posted results		38111	471	760
Publication
Published	902735	2401	5662	670
Unpublished	1506835	909	2954	383