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2014-8

A Resolution to Increase Public Awareness & Education on Participating in Clinical Trials

REPRESENTATIVE LOUIS RUIZ (KS) HEALTH CARE TASK FORCE

WHEREAS, developing new medicines is a complex process that involves clinical trials to explore whether a medical strategy, treatment or device is safe and effective for humans; and

WHEREAS, volunteer participation is necessary to evaluate potential therapies for safety and effectiveness in clinical studies; and

WHEREAS, often the enrolled patient population is not representative of U.S. demographics or sub-­? populations impacted by the particular disease; and

WHEREAS, groups such as African Americans and Hispanics are significantly underrepresented in clinical trials; and

WHEREAS, African-­?Americans represent 12% of the U.S. population but only 5% of clinical trial participants and Hispanics make up 16% of the population but only 1% of clinical trial participants;i ii and

WHEREAS, certain medical conditions have been known to affect particular demographic groups more than others, including diabetes where African Americans and Hispanics are on average twice as likely to be diagnosed with type II diabetesiii; and

WHEREAS, race and ethnicity have also been demonstrated to affect the efficacy and response of certain drugs, such as anti-­?hypertensive therapies in the treatment of hypertension in African Americans and anti-­?depressants in Hispanics.iv v vi; and

WHEREAS, many barriers exist that account for the low rate of participation amongst diverse communities including patient fear of experimentation iv and lack of understanding/education around the importance of clinical trials in creating new treatments and cures;

BE IT RESOLVED, that augmenting the representation of diverse populations of different racial and ethnic backgrounds in clinical research 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.

THIS RESOLUTION WAS RATIFIED ON DECEMBER 9, 2014 AT THE NHCSL ANNUAL MEETING HELD IN SAN JUAN, PUERTO RICO.

i Data presented by P. Sanders in "Dialogues on Diversifying Clinical Trials," Washington, D.C., 2011 Sept 22. http://www.womenshealthresearch.org/site/PageServer?pagename=events_clinicaltrials

ii Data presented by J. Tierney in "Dialogues on Diversifying Clinical Trials," Washington, D.C., 2011 Sept 22. http://www.womenshealthresearch.org/site/PageServer?pagename=events_clinicaltrials.

iii US Department of Health & Human Services – Office of Minority Health. “Minority Population Profiles” .

iv Johnson J. “Ethnic Differences in Cardiovascular Drug Response.” Circulation. 2008; 118: 1383-­?1393

Iv Powell J “The Project IMPACT Experience to Date: Increasing Minority Participation and Awareness of Clinical Trials” Journal of the National Medical Association 2008; 100: 178-­?187.

v Rao et al. “What is the best treatment for hypertension in African Americans?” The Journal of Family Practice. vol 56, No 2. February 2007.

vi Burroughs et al. “Racial and Ethnic Differences in Response to Medicines: Towards Individualized Pharmaceutical Treatment.” Journal of the National Medical Association. VOL. 94, NO. 10 (Suppl), October 2002.