Project IMPACT 

Increasing Minority Participation and Awareness of Clinical Trials 

By Brigette Settles Scott, MA


Closing the Gap, Working Toward Our Goal • August 2003


Research in the past few decades has uncovered significant 

differences among population groups in the metabolism,

 clinical effectiveness, and side effects of many prescription 

medications. The lack of information to support appropriate pharmaceutical interventions in minority patients further contributes to health 

disparities among people of color. Equally as important are the documented environmental, biological, cultural, and psychosocial factors 

which affect a patient’s ability to comply with drug regimens. 

“Until recently, there was no significant effort by the Food and 

Drug Administration to have the data that come out of clinical trials 

representative of the society,” said Dr. Michael A. Lenoir, principal 

investigator for the National Medical Association’s (NMA) Project 

IMPACT (Increasing Minority Participation and Awareness of Clinical Trials). “There are a number of studies that look at polymorphisms 

[naturally occurring variations in how individuals metabolize medications] and responses to medications in different ethnic groups. There 

is a clear distinction between how certain groups are represented by 

polymorphic gene pools, and how they respond to certain medications. So, consequently, most medications released in this country 

have never been studied adequately in minority populations, particularly African Americans.” 

While it is always important to talk about the preventive aspects 

of health promotion and disease management—early detection and 

early intervention—Lenoir maintains that pharmaceutical treatment 

is often the first line defense in minority communities because of 

traditionally later diagnosis and more chronic complications from various diseases. 

“Often, treatment simply comes down to the medications. Currently, there is no equitable information about what effect medicines 

have on our people. I think it is important to ensure that pharmaceutical products, which are released for distribution to minorities, are 

adequately studied in the populations that represent them. We must 

ensure that when a drug comes to market, and people start to take it, 

they can be assured that it has been representatively studied in all 

populations,” said Lenoir. 

Making an IMPACT 

The NMA has taken on a major effort to get more minority 

participation in clinical trials. Initially funded through a cooperative 

agreement with the Office of Minority Health (OMH), the goal of 

Project IMPACT is to increase knowledge and understanding, and to 

raise awareness about clinical trials among African American physicians and consumers, thereby increasing their participation in all aspects of clinical research. 

“Our objective initially was to simply educate and train physicians to become clinical investigators because it’s difficult to get people 

into clinical trials unless they trust the people who are doing it,” said 

Lenoir. “We’ve since expanded our program to educate African American patients about the value of participating in clinical trials,” he 

added. 

Education and training programs are the cornerstone of the 

project’s activities. Project IMPACT has three core programs designed 

to teach minority physicians and other health care providers about 

clinical research, its benefits, and reasons why participation is important for African Americans. The training includes a one-hour presentation, Clinical Research/Trials in Brief; a half-day workshop, Clinical 

Research Overview and Training; and a three-day intensive investigator course, Good Clinical Practices. 

According to Lenoir, Project IMPACT trained more than 500 

doctors from across the country during the last five years. “We’ve 

provided information on ethics, regulations, what’s involved in becoming a clinical researcher, and what resources are needed to do 

effective clinical trials. So now, we have a database of physicians who 

are able to talk rationally to their patient populations about clinical 

trials,” Lenoir said. 

“We also created consumer-based materials, including a great 

book, called You’ve Got the Power: What You Should Know about Clinical Trials. We distributed it as far as our resources have permitted to 

our physician base and large African American organizations,” Lenoir 

said. “Literacy is an issue for many Americans, so we also use a lot of 

media tools to talk about clinical trials. We also have ambassadors, who 

are prepared to go and talk to community groups around the issue of 

clinical trials,” he added. 

“It is our intent to engage in an honest dialogue locally and 

nationally with the African American community,” Lenoir continued. 

“We need to discuss in a rational way what clinical trials are and what 

the advantages and disadvantages are, so that we provide a more 

balanced prospective. We don’t want the narrow prospective that we 

got from our experience with Tuskegee and other studies,” said Lenoir. 

As a result, Project IMPACT now reaches more than 1,000 health 

care providers and consumers. It introduces them to the clinical research process, and the value of participation in clinical trials. In total, 

the Project conducted 19 clinical trials and developed and disseminated several consumer-directed educational brochures, videos, and 

fact sheets. 

In the future, Project IMPACT will interview the physicians 

who participated in the training program, but did not take part in a 

clinical trial to determine what the barriers are and how to overcome 

them. Ultimately, NMA hopes to expand the base of African American physicians who conduct clinical trials, and enroll more of the 

patients that they serve. 

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Office of Minority Health Resource Center 1 U.S. Department of Health and Human Services 

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Project IMPACT 

Increasing Minority Participation and Awareness of Clinical Trials 

By Brigette Settles Scott, MA


Closing the Gap, Working Toward Our Goal • August 2003


Grassroots Effort 

The Bay Area Multicultural Clinical Research and Prevention 

Center, located in Oakland, Calif., was founded by Lenoir to incorporate people of color in clinical research trials. The Center consists of a 

team of primary care and specialist physicians from within the African 

American community, who assist in the recruitment of patients, and 

serve as investigators to clinical trials. 

There are very few African American investigators at the local 

level, where most of the research is conducted. Lenoir believes that 

this disparity is a “clear violation of the scientific process.” He argues 

that if African American participation in clinical research does not 

increase, the impact on the community at large will be enormous. 

“Clinical trials are hard to do. You must be organized to do them. 

We are gradually getting more and more of our doctors to participate,” 

Lenoir said. “We’ve certainly been successful in engaging the community on a number of different levels about clinical trials,” Lenoir 

continued. “We’ve developed four investigators in this area, and have 

done 10 successful clinical trials. One of our major contributions to 

the trials has been African American participation. When the trial is 

finished, African Americans will be represented in the trial’s results.” 

However, these numbers are not enough. Lenoir believes that 

minority groups need to be more involved in clinical research if racial 

and ethnic disparities in health are to be eliminated. Educating physicians and helping the African American community understand 

both the advantages and disadvantages of clinical trials is a small step 

that has far-reaching implications. 

“We are continuing to get more people interested in clinical trials, 

and we’re working diligently to get physicians interested in not only 

serving as investigators, but developing their own clinical trial programs,” concluded Lenoir. 

For more information on Project IMPACT, call 202-347-1895.

For more information on the Bay Area Multicultural Clinical Research and Prevention Center, call 510-834-4897.

Project IMPACT is based on the Summit workshop “Minorities in Research: Its Impact on Health Disparities.” 

Office of Minority Health Resource Center 2 U.S. Department of Health and Human Services