Clinical trial transparency: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved recently in Europe

Figures & data

Figure 1. Systematic research methodology to identify company sponsored clinical trials relating to each new medicine and to assess the disclosure of results. IFPMA = International Federation of Pharmaceutical Manufacturers and Associations; EPAR = European Public Assessment Report.

Table 1. Total number of clinical trials posted on each registry relating to the 53 new medicines approved by the EMA in 2009, 2010 and 2011.

Registry	Total posted	Marked as complete
Company’s own	526	323
ClinicalTrials.gov	2852	1179
European Clinical Trials Register (clinicaltrialsregister.eu)	903	247
IFPMA portal (clinicaltrials.ifpma.org/clinicaltrials/index)	3,642	252

Number of trials includes those registered by industry and other sponsors, and ongoing and completed trials. There is considerable overlap and duplication of trial records within these four sources.

Figure 2. Chart showing breakdown of trial assessment at 12 months.

Table 2. Number of completed company-sponsored clinical trials relating to 53 new medicines approved in 2009, 2010 and 2011 which had disclosed results, grouped by phase of study.

Phase	Total trials	Unevaluable at 12 months*	Results disclosed within 12 months^≠		Unevaluable at 31/01/13*	Results disclosed by 31/01/13
I/II	503	83	306/420	73%	38	400/465	86%
III	434	67	301/367	82%	56	347/378	92%
IV	41	23	11/18	61%	18	21/23	91%
Other	19	17	1/2	50%	3	16/16	100%
Total	997	190	619/807	77%	115	784/882	89%

*Unevaluable if a key date was missing or unclear, or 12 months had not elapsed since trial completion.

^≠Twelve months measured from date of first regulatory approval (Europe or US), or trial completion date if later than first approval.

Figure 3. Chart showing breakdown of trial assessment at 31 January 2013.

Table 3. Number of completed company-sponsored clinical trials relating to 21 new medicines approved in 2009 which had disclosed results, grouped by phase of study.

Phase	Total trials	Unevaluable at 12 months*	Results disclosed within 12 months^≠		Unevaluable at 31/01/13*	Results disclosed by 31/01/13
I/II	274	26	167/248	67%	16	213/258	83%
III	216	33	141/183	77%	28	169/188	90%
IV	25	10	9/15	60%	10	13/15	87%
Other	5	4	0/1	0%	2	3/3	100%
Total	520	73	317/447	71%	56	398/464	86%

*Unevaluable if a key date was missing or unclear, or 12 months had not elapsed since trial completion.

^≠Twelve months measured from date of first regulatory approval (Europe or US), or trial completion date if later than first approval.

Table 4. Number of completed company-sponsored clinical trials relating to 12 new medicines approved in 2010 which had disclosed results, grouped by phase of study.

Phase	Total trials	Unevaluable at 12 months*	Results disclosed within 12 months^≠		Unevaluable at 31/01/13*	Results disclosed by 31/01/13
I/II	99	41	51/58	88%	9	88/90	98%
III	94	11	63/83	76%	8	75/86	87%
IV	9	7	1/2	50%	2	7/7	100%
Other	12	11	1/1	100%	0	12/12	100%
Total	214	70	116/144	81%	19	182/195	93%

*Unevaluable if a key date was missing or unclear, or 12 months had not elapsed since trial completion.

^≠Twelve months measured from date of first regulatory approval (Europe or US), or trial completion date if later than first approval.

Table 5. Number of completed company-sponsored clinical trials relating to 20 new medicines approved in 2011 which had disclosed results, grouped by phase of study.

Phase	Total trials	Unevaluable at 12 months*	Results disclosed within 12 months^≠		Unevaluable at 31/01/13*	Results disclosed by 31/01/13
I/II	130	16	88/114	77%	13	99/117	85%
III	124	23	97/101	96%	20	103/104	99%
IV	7	6	1/1	100%	6	1/1	100%
Other	2	2	0/0		1	1/1	100%
Total	263	47	186/216	86%	40	204/223	91%

*Unevaluable if a key date was missing or unclear, or 12 months had not elapsed since trial completion.

^≠Twelve months measured from date of first regulatory approval (Europe or US), or trial completion date if later than first approval.