Skip to main content
. 2016 Nov 24;5:19–25. doi: 10.1016/j.conctc.2016.11.005

Table 1.

Sponsorship, conflict of interest, risk of bias, and reporting of participant's flow and baseline demographic information in studies that must comply with the US Public Law 110-85 to post the results in clinicaltrials.gov.

Study characteristics Number of studies % of total applicable studies
Applicable clinical trial as defined in US Public Law 110-85, Title VIII, Section 801 44,635
Industry involvement in sponsoring the study 27,995 62.7
Principal investigators are employed by sponsoring organization 1910 4.3
Principal investigators are not employed by sponsoring organization 9325 20.9
Employment of principals investigators by sponsoring organization is not reported 33,400 74.8
Risk of bias
Allocation of subjects: randomized 26,635 59.7
Allocation of subjects: non-random 5526 12.4
Allocation of subjects not reported 12,474 27.9
Terminated 3789 8.5
Double-blind study 17,089 38.3
Open Label study 22,748 51.0
Single Blind study 2357 5.3
Masking not reported 2441 5.5
Study design
Phase not reported 6998 15.7
Phase 0 292 0.7
Phase 1 3890 8.7
Phase 1/Phase 2 3063 6.9
Phase 2 14,534 32.6
Phase 2/Phase 3 1051 2.4
Phase 3 9553 21.4
Phase 4 5254 11.8
Participants flow
Reported attrition ( # of subjects not completed the study) 8133 18.2
Reported study discontinuation due to adverse effects 3366 7.5
Baseline patient characteristics
Reported baseline age of enrolled patients 8218 18.4
Both genders enrolled 38,379 86.0
Female studies 3782 8.5
Male studies 1855 4.2
Gender not reported 619 1.4
Reported # of Asian patients 1918 4.3
Reported # of African-American patients 1928 4.3
Reported # of Hispanic patients 486 1.1
Reported # of Native American patients 1481 3.3