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. 2017 Mar 8;6:31–38. doi: 10.1016/j.conctc.2017.02.009

Table 2.

Funder, trial, organization type, and site location of “one-and-done” investigators' one FDA-regulated drug trial and other trials conducted.

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)
a

Investigators selected all that applied; data missing from 3 investigators.

b

This included four Phase IV trials; trial phase unclear in other responses.