Skip to main content

Table 3 Factors independently associated with reporting statistically significant results (i.e., reporting a p-value <0.05 or treatment effect with 95% CI not including the null value) for the first primary outcome posted at ClinicalTrials.gov for completed superiority clinical trials

From: Reporting of statistically significant results at ClinicalTrials.gov for completed superiority randomized controlled trials

Characteristics

Adjusted OR (95% CI)

p-value

Phase of the trial

Phase 3 versus 4

1.68 (1.38–2.04)

<0.0001

Intervention

Drug versus other

1.20 (0.97–1.48)

0.10

Control group

Inactive versus active

2.19 (1.83–2.61)

<0.0001

Sponsorship

Industry (totally or partially) versus academic

1.57 (1.22–2.03)

0.0005

FDAAA

Subject versus not subject

1.15 (0.94–1.41)

0.17

Countries

Multiple countries versus single country

1.58 (1.29–1.93)

<0.0001

 

Not reported versus single country

1.50 (1.14–1.98)

0.004

Sample size

For an increase of 100 patients

1.002 (0.99–1.005)

0.20

  1. OR odds ratio, CI confidence interval, FDAAA US Food and Drug Administration Amendments Act