Illinois HR 100: CONGRESS-PASS MED EQUITY LEGIS

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HR0100LRB104 11874 ECR 21965 r

1HOUSE RESOLUTION

2 WHEREAS, The Nu Paradigm Foundation has proposed 

3legislation to be presented before the U.S. Congress that 

4would ensure that the demographic profile in clinical drug 

5trials is representative of the population that will use the 

6drug upon approval by the U.S. Food and Drug Administration 

7(FDA), thereby promoting equitable access to safe and 

8effective medication for all communities; and

9 WHEREAS, For the purpose of this proposed legislation, 

10"demographic representation" means the inclusion of diverse 

11participants in clinical trials, taking into account factors 

12such as age, gender, race, ethnicity, socioeconomic status, 

13and health conditions, and "clinical trial" refers to any 

14research study that involves human participants and is 

15designed to evaluate the effects and efficacy of a drug; and

16 WHEREAS, Under this proposed legislation, all sponsors of 

17clinical trials for drug approval shall submit a diversity 

18plan as part of their Investigational New Drug (IND) 

19application; this plan shall outline strategies to ensure that 

20trial participants reflect the demographics of the intended 

21patient population; this plan must establish specific 

22recruiting goals for demographic groups that are 

23underrepresented in trial, including, but not limited to, 

HR0100- 2 -LRB104 11874 ECR 21965 r

1racial and ethnic minorities, women, and individuals with 

2disabilities; sponsors shall also be required to report the 

3demographic composition of the trial participants at the end 

4of the trial and provide an explanation in the event the trial 

5did not meet the established recruitment goals; and

6 WHEREAS, Under this proposed leg