A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010: the relationship between industry sponsorship and randomized study design

Table 3 Association between trial characteristics and industry sponsorship in eligible HIV/Hepatitis C interventional trials, ClinicalTrials.gov registry, 2007 to 2010 (N = 477)

Characteristic	Industry-sponsored	Non-industry-sponsored	PR^c	95% CI
Number of participants^a
Median (IQR)	120 (50,290)	60 (30,140)
Less than or equal to 100	84	204	1.0
101 to 1,000	89	84	1.76	1.31, 2.38
Greater than 1,000	5	9	1.22	0.50, 3.02
Start year^a
Before 2007	24	39	1.0
2007	16	26	1.0	0.53, 1.88
2008	55	75	1.11	0.69, 1.79
2009	52	85	1.0	0.61, 1.62
2010	30	68	0.80	0.47, 1.37
Phase
2/3	153	131	1.0
4	26	167	0.25	0.16, 0.38
Study has DMC^ab
No	69	138	1.0
Yes	52	137	0.83	0.58, 1.18
Excludes > 65 years
No	128	224	1.0
Yes	51	74	1.12	0.81, 1.55
Number of study sites^a
Single facility	24	181	1.0
Multiple facilities	112	113	4.25	2.74, 6.61
Foreign sites
No	25	101	1.0
Yes	154	197	2.21	1.45, 3.37
Condition
Hepatitis C (HCV)	99	57	1.0
HIV/AIDS	76	228	0.39	0.29, 0.53
HCV + HIV/AIDS	4	13	0.37	0.14, 1.01

^aTotals for each variable may not add up to N = 468 secondary to observations with missing data.
^bDMC = data monitoring committee.
^cPR = unadjusted prevalence ratio, calculated from Poisson regression model with covariate as exposure and industry sponsorship as outcome.
IQR = interquartile range.

ISSN: 1745-6215