Table 2.
Variable |
N = 93 n (%) |
---|---|
The one FDA-regulated drug trial | |
Fundera | |
Pharmaceutical industry | 69 (76.7) |
U.S. government | 11 (12.2) |
Investigator-initiated and funded | 5 (5.6) |
Private foundation | 3 (3.3) |
Non-governmental organization | 2 (2.2) |
Other | 2 (2.2) |
Trial | |
Safety trial (typically Phase I) | 13 (14.0) |
Proof of concept or dose-ranging trial (typically Phase IIa/b) | 22 (23.7) |
Pivotal trials for registration (typically Phase III) | 47 (50.5) |
Otherb | 11 (11.8) |
Organization type | |
Academic institution/academic health system with research and education opportunities | 60 (64.5) |
Community or private practice with primary clinical responsibility | 28 (30.1) |
Hospital with no affiliated academic institution | 2 (2.2) |
Federal government agency | 1 (1.1) |
Dedicated research site with no affiliated clinical practice responsibility | 0 (0.0) |
Pharmaceutical industry | 0 (0) |
Other | 2 (2.2) |
Site location | |
Study site(s) in the U.S. | 84 (90.3) |
Study site(s) outside of the U.S. | 0 (0) |
Study sites in the U.S. and outside of the U.S. | 9 (9.7) |
Involved in non-FDA-regulated medical research | N = 72 n (%) |
Types of other medical research | |
Clinical research (e.g., observational, prognostic, diagnostic) | 50 (69.4) |
Phase I, II, or III drug or device clinical trials without an Investigational New Drug Application or investigational device exemption | 29 (40.3) |
Epidemiological research (e.g., observation, cohort, case control) | 21 (29.2) |
Post-approval studies | 17 (23.6) |
Medical device clinical trials | 11 (15.3) |
Other | 4 (5.6) |
Funding for the other medical research | |
Investigator-funded | 39 (54.2) |
Pharmaceutical industry | 35 (48.6) |
U.S. government | 30 (41.7) |
Foundation | 23 (31.9) |
Non-governmental organizations | 8 (11.1) |
Other | 2 (2.8) |
Investigators selected all that applied; data missing from 3 investigators.
This included four Phase IV trials; trial phase unclear in other responses.