[Congressional Record (Bound Edition), Volume 155 (2009), Part 17]
[Extensions of Remarks]
[Page 23473]
[From the U.S. Government Publishing Office, www.gpo.gov]




  RECOGNIZING TIBOTEC THERAPEUTICS FOR CONDUCTING THE GRACE STUDY, A 
GROUND BREAKING HIV CLINICAL TRIAL FOCUSED ON WOMEN AND PEOPLE OF COLOR 
                          IN THE UNITED STATES

                                 ______
                                 

                           HON. WM. LACY CLAY

                              of missouri

                    in the house of representatives

                       Thursday, October 1, 2009

  Mr. CLAY. Madam Speaker, I rise today to commend and congratulate 
Tibotec Therapeutics, part of the Johnson & Johnson family of 
companies, for demonstrating continued innovation and corporate 
responsibility in the fight against HIV/AIDS by conducting the 
groundbreaking GRACE study. GRACE, which stands for Gender Race And 
Clinical Experience, is the largest study to date in treatment-
experienced women with HIV to examine gender and race differences in 
response to an HIV therapy. In recent HIV studies of treatment-
experienced patients, women accounted for less than 11 percent of the 
patients being studied, on average. GRACE was able to enroll nearly 70 
percent women and 84 percent people of color.
  In my home State of Missouri, there are almost 12,000 people living 
with AIDS, and African Americans represent over a third of these cases. 
Women account for more than one quarter of all new HIV/AIDS diagnoses 
in the United States, with African American and Latina women 
representing 79 percent of women living with the disease. People of 
color have been historically underrepresented in clinical trials in the 
United States, and HIV/AIDS disproportionately impacts African 
Americans. In terms of new HIV infections, African American women are 
infected at a rate 15 times higher than white women.
  The trial was designed to help overcome some of the barriers, 
identified by the advisors, which have historically deterred women and 
people of color from participating in clinical studies, including 
stigma, lack of child care, transportation and personal support 
systems. Based upon advisor and community input, study participants 
could obtain assistance to cover costs associated with their 
participation in the study, including funds for travel and childcare, 
as well as food vouchers. I am proud to say that one of the study sites 
in this historic clinical trial is located in my congressional 
district.
  Results of the GRACE study showed that there were no statistical 
differences in the safety, tolerability or effectiveness of the HIV 
regimens used in the study between male and female participants, or for 
people of different ethnicities. Additionally, the GRACE study showed 
that with the appropriate commitment from the trial sponsor and input 
from affected communities and providers, clinical trials can enroll 
meaningful numbers of women and racial and ethnic minorities.
  Madam Speaker, I commend Tibotec Therapeutics and Johnson & Johnson 
for their commitment to addressing the disproportionate impact of this 
epidemic on women and people of color.

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