Table 1

Age groups of study participants, geographical regions of recruitment, study phase and sponsorship of trial records included in the study

	Records from trials that reported collection of pharmacokinetic data (N=257)		Records from trials that did not report collection of pharmacokinetic data (N=824)		Total	Percentage of total reporting collection of pharmacokinetic data per age group, region, phase or sponsor
	No of records	Percentage of N=257	No of records	Percentage of N=824	Total
Age^*
Newborn infants (0 to 27 days)	81	32	226	27	307	26
Infants and toddlers (28 days to 23 months)	126	49	371	45	497	25
Children between the ages of 2 and 11 years	190	74	680	83	870	22
Not indicated	3	1	19	2	22	–
Geographical region^*
Africa	16	6	44	5	60	27
Asia	26	10	94	11	120	22
Europe	50	19	217	26	267	19
Latin America and the Caribbean	25	10	61	7	86	29
Northern America	199	77	469	57	668	30
Oceania	13	5	83	10	96	14
Not specified	12	5	35	4	47	–
Phase
0	0	0	3	0	3	0
1	69	27	43	5	112	62
1 and 2	31	12	23	3	54	57
2	45	18	149	18	194	23
2 and 3	11	4	32	4	43	26
3	38	15	215	26	253	15
3 and 4	0	0	4	0	4	0
4	15	6	146	18	161	9
Not indicated	48	19	209	25	257	–
Sponsorship
Collaborative research groups	25	10	80	10	105	24
Federal	39	15	84	10	123	32
Industry	67	26	114	14	181	37
University or hospital	121	47	502	61	623	19
Other^†	5	2	43	5	48	10
Not indicated	0	0	1	0	1	–
Total	257		824		1081

* Percentages for geographical regions and age groups do not add up to 100% because records regularly pertain to trials recruiting in multiple regions, or recruiting in multiple age groups.
† Other sponsorship included foundations, contract research organisations, research centres and individuals.