S.C.R. 2

1

RESOLUTION REGARDING CLINICAL
2 TRIALS FOR WOMEN'S HEALTH CARE
3 2003 GENERAL SESSION
4 STATE OF UTAH
5 Sponsor: Paula F. Julander
6 This concurrent resolution of the Legislature and the Governor urges the Food and Drug
7 Administration to strictly enforce requirements that clinical study sponsors perform
8 subgroup analysis of their studies to ensure that the health concerns of women are
9 appropriately addressed in clinical trial results.
10 Be it resolved by the Legislature of the state of Utah, the Governor concurring therein:
11 WHEREAS, there is a pressing need to collect and assess more accurate data regarding
12 the health of women;
13 WHEREAS, subgroup analysis, a statistical procedure, takes data from a general group
14 of study subjects and looks for differences within a subset of those subjects that share a specific
15 characteristic, such as sex, age, or state of disease;
16 WHEREAS, studies have shown that, to improve the quality and appropriateness of
17 health services, the gender of those participating in clinical trials must be factored into all
18 levels of biomedical research, creating a new paradigm for data analysis;
19 WHEREAS, despite the mounting evidence of the need for subgroup data analysis
20 based on gender, recent reports show that analysis is either not being conducted or not being
21 reported;
22 WHEREAS, although a 1993 policy guideline and a 1998 regulation by the Food and
23 Drug Administration recommends that study sponsors perform subgroup analysis of their
24 studies, it is clear that these recommendations are not being followed;
25 WHEREAS, a July 2001 report of the General Accounting Office found that about
26 one-third of new drug applications submitted to the Food and Drug Administration by study
27 sponsors failed to provide gender-specific data from subgroup analysis conducted during the

28 clinical trials; and
29 WHEREAS, without subgroup analyses, researchers and clinicians cannot truly assess
30 the safety and efficacy of new drugs for women, and the development of potentially life saving
31 drugs may be abandoned if early trials fail to show efficacy in one gender:
32 NOW, THEREFORE, BE IT RESOLVED that the Legislature of the state of Utah, the
33 Governor concurring therein, strongly urge the Food and Drug Administration to strictly
34 enforce requirements that clinical study sponsors perform subgroup analysis of their studies to
35 ensure that the health concerns of women are appropriately addressed in clinical trial results.
36 BE IT FURTHER RESOLVED that a copy of this resolution be sent to the Food and
37 Drug Administration, the Utah Department of Health, and the members of Utah's congressional
38 delegation.




Legislative Review Note
as of 1-24-03 11:40 AM

A limited legal review of this legislation raises no obvious constitutional or statutory concerns.

Office of Legislative Research and General Counsel