About The Center's Research Programs
The Asthma and Allergy Center of Chicago conducts clinical research because we believe that it is not enough for physicians just to treat individual medical problems; the Center is dedicated to helping our community understand illness, and help find better care solutions. Our primary focus is on patient care. The Center has a proven record; our expertise and solutions work. Since our inception in 1994, fewer than ten asthma patients, out of the thousands under our direct care, have been hospitalized.
Participation in the Center's clinical research programs is based solely upon study specific medical criteria; participation is open to all people regardless of race, ethnicity, or socioeconomic status. There are no participation costs to individuals, nor charges to any third parties, local, state, or federal entities for any research related services. All qualified participants receive, at no cost, all study-related: medical specialist supervision, disease education, study medications, lab tests, clinic visits, and compensation for time and travel expense.
Since conducting our first research trial in 1994, the Asthma and Allergy Center of Chicago has
distinguished itself as a leading institution in Chicago conducting
participatory respiratory research. Attracting
patients from the entire Chicago metropolitan population, the Center
seeks to enroll a high percentage of subjects
from all socioeconomic and racial backgrounds in its respiratory research trials. The Center conducts research only
in its areas of proven expertise: respiratory disease (asthma, COPD,
allergies). As policy, the Center has no other financial
relationships with pharmaceutical companies other than direct research
support (see link Asthma & Allergy Center of Chicago, SC for Center Code of Conduct and Conflict of Interest).
The Collaborative Objective
Through collaboration and involvement of practicing physicians and other allied healthcare professionals throughout the Chicago community, the Center seeks to increase the opportunities for people with COPD and asthma and allergic diseases to participate in clinical research programs.
The Need for Collaborative Solutions to Improve Access to Participation in Clinical Research and Community Health1
Despite the passage in 1993 of the National Institutes of
Health (NIH) Revitalization Act, mandating that women and minorities be
included in NIH-funded research, racial, ethnic, and socioeconomically disadvantaged communities remain consistently underrepresented in clinical research trials. Although the proportions vary, of the largest ethnic and racial groups, Latinos
and African-Americans tend to be the most underrepresented.
In clinical trials funded by the
National Cancer Institute that were being conducted in 2002, 86.6% of
participants were white, 7.9% were African-American, 3.0% were Latino, 2.2%
were Asian-American or Pacific Islanders, and 0.3% were Native Americans or
Similarly, studies of minority and disadvantaged population enrollment in clinical trials conducted by the pharmaceutical industry reflect the same low participation rates. Whereas NIH and federally funded trials tend to look at larger epidemiological and socioeconomic medical issues, pharmaceutical industry trials establish the databases of
information that the FDA uses for approval of investigational
medications and devices and for the ongoing post-marketing review of approved
products. These industry
sponsored trials constitute the majority of clinical research trials
conducted in this country.
When a large proportion of the population such as minority and disadvantaged populations fail to participate in pharmaceutical sponsored clinical trials, serious questions arise regarding the relevance of the overall safety and benefit data of drugs submitted for FDA approval. Furthermore, as most pharmaceutical company funded clinical trials provide active disease treatment, the lack of involvement of minority and disadvantaged populations in these studies represents yet another lost opportunity to provide medical services to these communities,
Why has so little changed since researchers been paying attention to these issues? As cited by Friedman and others, there are many theories as to why this situation developed and persists, including: 1) accusations of racism on the part of researchers to distrust in the system on the part of minorities, 2) lack of insurance and the fear that participation may risk current insurance status, 3) immigration status, 4) insufficient English-language skills or literacy, 5) unwillingness of community organizations and local healthcare providers to refer patients for research, and, 6) lack of transportation to research sites.
Research changes lives...Our Mission is but one effort aimed towards getting information about research opportunities to all those people, disadvantaged or not, who may be interested in participating.
1Friedman, E. Supporting Diversity in Research Participation:A Framework for Action. Independent Health Policy and Ethics Analyst, CIRM Contract No. 2214. Submitted November 30, 2009