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Table 2 Registration, publication, and interpretation concordance of clinical trials supporting FDA new drug approvals in cardiovascular disease and diabetes between 2005 and 2014, pre and post FDAAA

From: Association of the FDA Amendment Act with trial registration, publication, and outcome reporting

 

Number of studies (%)

Registered, n (%)

Odds ratio (95% CI), p value

Published, n (%)a

Odds ratio (95% CI), p value

Concordant interpretation, n. (%)a

Odds ratio (95% CI), p value

Overall

183 (100)

151 (83)

 

169 (92)

 

152 (90)

 

Trial completion date

       

 Pre FDAAA

105 (57)

73 (70)

–, <0.0001

93 (89)

0.20 (0.04 to 0.94), 0.03

78 (84)

0.14 (0.03 to 0.64), 0.004

 Post FDAAA

78 (43)

78 (100)

 

76 (97)

 

74 (97)

 
  1. CI confidence interval, FDA US Food and Drug Administration, FDAA FDA Amendment Act, – too few events to calculate odds ratio
  2. a“Published” includes publication in the peer-reviewed literature. The “Concordant interpretation” column uses “Published” as the denominator to determine percentages