Policy Resolution HHS-15-35
WHEREAS, developing new medicines and other treatment options is a complex process that involves clinical trials to explore whether a medical strategy, treatment, or device is safe and effective for humans;
WHEREAS, volunteer participation is necessary to evaluate potential therapies for safety and effectiveness in clinical studies;
WHEREAS, often the enrolled patient population is not representative of U.S. demographics or sub-populations impacted by the particular disease;
WHEREAS, groups such as African Americans and Hispanics are significantly underrepresented in clinical trials; with, African Americans representing 12 percent of the U.S. population but only 5 percent of clinical trial participants, and Hispanics comprising 16 percent of the population but only 1 percent of clinical trial participants, according to the Food and Drug Administration;
WHEREAS, despite a Congressional mandate that research financed by the National Institutes of Health include minorities, non-Whites comprise fewer than 5 percent of participants in NIH supported studies;
WHEREAS, certain medical conditions have been known to affect particular demographic groups more than others, including type II diabetes for which African Americans and Hispanics are twice as likely to be diagnosed on average;
WHEREAS, according to the Centers for Disease Control and Prevention, sickle cell trait is common among African Americans and occurs in about 1 in 12, and sickle cell disease occurs in about 1 out of every 500 African-American births, compared to about 1 out of every 36,000 Hispanic-American births;
WHEREAS, race and ethnicity have also been demonstrated to affect the efficacy of and response to certain drugs, such as anti-hypertensive therapies in the treatment of hypertension in African Americans and anti-depressants in Hispanics; and
WHEREAS, many barriers exist that account for the low rate of participation among diverse communities, including patient fear of experimentation and lack of understanding or education with regard to the importance of clinical trials in creating new treatments and cures.
THEREFORE BE IT RESOLVED, that the National Black Caucus of State Legislators (NBCSL) supports ensuring that diverse populations of different racial and ethnic backgrounds are represented in clinical research, as this is an important issue that warrants the dedication of additional community resources to
- increase awareness on the importance of participating in clinical trials,
- provide support for patient participation, and
- promote effective partnerships with the community to achieve solutions; and
BE IT FINALLY RESOLVED, that a copy of this resolution be transmitted to the President of the United States, the Vice President of the United States, members of the United States House of Representatives and the United States Senate, and other federal and state government officials as appropriate.
- SPONSOR: Senator Donne Trotter (IL)
- Committee of Jurisdiction: Health and Human Services Policy Committee
- Certified by Committee Chair: Senator Willie Simmons (MS)
- Ratified in Plenary Session: Ratification Date is December 12, 2014
- Ratification is certified by: Representative Joe Armstrong (TN), President