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 |