KEI was asked to look at federal support for research and development on (Enbrel) etanercept.
A November 1, 2009 search of the NIH CRISP database reports 167 federal grants for research on etanercept.
A November 1, 2009 search of ClinicalTrials.Gov reports 230 studies, including 39 funded by the NIH or other federal agencies, 79 funded by universities or other organizations, and 153 funded by industry. Some trials are counted in more than one category, when there is mixed sources of funding.
The most risky trials are Phase I and II trials. The most expensive discovery trials are Phase III trials. Phase III trials are far less risky than Phase I or II trials.
Phase IV trials occur after products are on the market.
In the critical and high risk Phase I and II drug discovery stages, there are 29 trials funded by NIH or other federal agencies, 53 funded by universities or other organizations, and 25 trials funded by industry.
In the Phase III stage, there are 6 trials funded by the NIH or other federal agencies, 14 by universities and other, and 44 funded by industry.
In the Phase IV, post marketing stage, there are 3 funded by the NIH or other federal agencies, 12 by universities and other, and 60 by industry.
| Number of trials by source of funding | |||
| Discovery | |||
| Source of funding |
NIH and other federal |
universities and other |
industry |
| Phase I | 4 | 14 | 7 |
| Phase II | 25 | 39 | 18 |
| Phase III | 6 | 11 | 44 |
| Post market approval | |||
| Phase IV | 3 | 12 | 60 |
For trials that have either some or only industry funding, and where the trial is ‘Interventional,” the number of enrolled patients in Phase I, II and III trials is large, 16.465, including 15,011 patients in the late stage and less risky Phase III trials. This is a large number, compared to most drugs.
In some cases, etanercept has qualified as an orphan drug. In such cases, 50 percent of the qualified costs of trials are subsidized by the federal government through tax credits.
Comment
The development of Enbrel has benefited from extensive federal support from the public and non-profit sectors. This is particularly true in the most risky stages of development, including Phase I and II clinical trials. Industry has provided the most important source of financing for the later stages of research, including in particular for post marketing studies.