| 2004D-0014 - Draft Guidance for Industry on Information Program on Clinical Trials for Serious or Life- Threatening Diseases and Conditions; Availability|
|FDA Comment Number :||EC1|
|Submitter :||Mrs. Danna Carver||Date & Time:||03/30/2004 05:03:45|
|Organization :||University of Arkansas for Medical Sciences|
| The University of Arkansas for Medical Sciences (University) wishes to comment on the Food and Drug Administration's proposed 'Guidance for Industry on Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions', 69 FR 3923, January 27, 2004.
The University is an institution with a large clinical research program involving both industry-sponsored and sponsor-investigator research. The aforementioned guidance addresses only industry sponsored research and makes no provision for sponsor-investigator research, commonly referred to by the Food and Drug Administration as 'research INDs.'
Section 113 of the Public Health Service Act, 42 USC 282, makes no distinction between industry trials and sponsor-investigator trials. If the clinical trials meet the following criteria, 1) a phase 2, 3, or 4 clinical trial and, 2) is designed to demonstrate effectiveness with efficacy endpoints, the clinical trial must be listed in the Clinical Trails Data Bank. There is an 'opt-out' section for investigators under 113(b)(4).
The University respectfully requests that the Agency consider including a statement in this guidance regarding the applicability of the rule to sponsor-investigator clinical trials.
We hope that the Agency will give careful consideration to the recommendation of the University and we wish to thank the Agency for the opportunity to comment on this guidance.
Danna K. Carver, Director, Office of Research Compliance