Table 4

Characteristics of the CTIMPs by trial phase

Trial phase*	Ph I		Ph II		Ph III		Ph IV		Total
Characteristic	N	%	N	%	N	%	N	%	N	%
All entries, N	99		287		324		98		808
Design characteristics
Neither	86	89	261	93	303	94	90	94	740	93
Adaptive	1	1	7	2	13	4	3	3	24	3
Bayes	10	10	12	4	5	2	2	2	29	4
Both	0	0	2	1	0	0	1	1	3	0
Cluster randomised	0	0	0	0	0	0	0	0	0	0
Stepped wedge	0	0	0	0	0	0	0	0	0	0
Involves placebo	21	22	123	44	163	51	25	26	332	42
Independent data monitoring committee
No	40	82	84	59	61	42	46	78	231	58
Yes	9	18	59	41	84	58	13	22	165	42
Missing	8		139		176		37		400
Methods of dissemination
Peer-reviewed scientific journal	86	89	265	94	290	90	93	97	86	89
Submission to regulatory authority	85	88	215	76	272	85	48	50	85	88
Conference presentation	82	85	253	90	271	84	89	93	82	85
Internal report	71	73	212	75	259	81	60	63	71	73
Publication on website	56	58	161	57	203	63	45	47	56	58
Other publication	26	27	76	27	92	29	17	18	26	27
Access to raw data	8	8	12	4	25	8	8	8	8	8
Other	12	12	47	17	48	15	18	19	12	12
No plans to report or dissemination	0	0	0	0	2	1	0	0	0	0
Areas of PPI activity†
Design of the research	26	27	82	29	39	12	50	52	26	27
Management of the research	10	10	34	12	28	9	31	32	10	10
Undertaking the research	14	14	47	17	36	11	29	30	14	14
Analysis of results	1	1	15	5	7	2	12	13	1	1
Dissemination of findings	20	21	74	26	64	20	44	46	20	21
None of the above	53	55	149	53	223	69	35	36	460	58
REC opinion
Favourable	97	98	277	97	318	98	93	95	785	97
Favourable	14	14	51	18	40	12	15	15	120	15
Favourable (after extra info)	83	84	226	79	278	86	78	80	665	82
Unfavourable	0	0	5	2	3	1	3	3	11	1

*Trial phase calculated.
†Not mutually exclusive.
CTIMP, clinical trials of investigational medicinal product; PPI, patient and public involvement; REC, Research Ethics Committee.