September 6, 2006

By Dorie Hightower

Posted in: Clinical trials | Special Populations

Tags: clinical trial, genetics, health disparities, incidence, minority, mortality, rates

Clinical trials are crucial for the development of effective prevention, diagnostic and treatment methods for cancer and other diseases.  While participation in cancer clinical trials is generally low overall (around three percent for adults), minorities and underserved communities, especially African Americans and those living in rural areas, are particularly under-represented. Because access to cutting edge advances and state-of-the art care that clinical trials provide is not always available to people in those communities, these inequities in participation contribute to ongoing health disparities.

Claudia Baquet, M.D., professor of medicine and associate dean at the University Of Maryland School Of Medicine, in Balto., Md., is a leading national expert on cancer in minority and low-income populations, and serves as an advocate for better health care, including issues related to health disparities and underserved populations. BenchMarks talked with her about some of the obstacles to minority participation in clinical trials and what can be done about them.   

Why do minorities have a low participation rate in clinical trials?

The reasons are complex and numerous. Often physicians don’t discuss the availability of trials with minority patients, and there is a lack of information in the community about the potential benefits of participating in clinical trials.  In addition, there aren’t enough trials in community settings where people affected by disparities often live. Another problem is the design of clinical trials themselves — the eligibility criteria are very rigorous, are standardized, and may exclude patients with multiple health problems, many of whom are minorities. 

In what way are people excluded from trials when they have other conditions?

Take, for example, the SELECT trial (the Selenium and Vitamin E Cancer Prevention Trial),a clinical trial to see if either of these dietary supplements could reduce the risk of prostate cancer in high risk patients, such as African American males. While national accrual to this study went well, patients who had uncontrolled hypertension were not eligible and were excluded.  Well, some of the communities that are at most risk for higher incidence for prostate cancer also have a higher prevalence of hypertension.  So minority populations can be restricted from clinical trials just because of how the trial is designed and eligibility criteria developed. Other conditions that may preclude people from participating in trials include diabetes, peripheral arterial disease, and chronic pulmonary disease.  It depends on the trial design and criteria.

How does low participation in clinical trials contribute to health disparities?

Clinical research is a critical resource for the development of new prevention, diagnosis, and treatment techniques for a number of diseases, including cancer.  Whether one can trust and apply the results of a clinical trial, as well as transfer them into clinical practice, is related to the type and number of patients that are enrolled in the trial.  If trials do not include minorities, then there’s a question of whether or not the results of the studies are relevant to everyone across the board. To specifically address this problem, Congress inserted language in the National Institutes of Health (NIH) Revitalization Act which states that NIH clinical research must include ample numbers of minorities, as well as women, in order to allow for in-depth analyses of minority populations.

Does the legacy of the TuskegeeSyphilis Study still have an effect on perceptions about the safety of clinical trials?

Tuskegee still is on people’s minds, especially in the African American community. People don’t understand how another Tuskegee would be prevented today — an informed public, as well as physicians and other health professionals, is essential in this regard.  That’s why it’s important that community and local health professionals receive ongoing training in human subjects protection and current regulations that are in place today that would prevent something like this from taking place again.  Physicians also need to be able to effectively communicate these safeguards to their patients to help build trust and overcome any perceptions of mistrust. 

Are people in minority communities reluctant to participate in clinical trials because it might require additional office visits or distant travel to a cancer center?

There’s more to it than that.  In our recent study, we found that patients whose physicians informed them about available clinical trials were more likely to participate once asked.  However, it is also important to have more trials in community settings that don’t have a cancer center or a teaching hospital.

Our experience in Maryland, over a five-year period, showed that you can dramatically increase the availability of cancer trials in rural settings, as well as the participation of rural patients, including rural African Americans. But the problem is that we don’t have enough clinical trials being developed.

And that emphasizes the importance of the “discovery” piece of the puzzle — the Discovery, Development, Delivery disconnect.  There are many things we can do now to potentially eliminate disparities if the standards of care were available to all communities equally.  More research is necessary to design new drugs that can respond to whatever environmental, genetic, or other biological differences exist between individuals or populations.

What kinds of outreach programs have been proven to work?

The model that we developed for the Eastern Shore of Maryland, which was adopted by the Secretary of the U.S. Department of Health and Human Services as the part of the National Best Practice Initiative, shows great promise — not only for rural settings, but possibly for other community settings around the country.

We use a multi-pronged approach that includes ongoing public education on what clinical trials are and their potential benefits. Methods for assuring human research participant protections are always a part of these lectures. That involved going into neighborhoods, attending community events, churches, and getting support from the leaders of different faiths to help get the word out.

Secondly, we provide continuing education for local community health care professionals — physicians, nurses, and nurse practitioners.  We offer an introductory lecture on trial design, and provide information on the potential benefits for their patients and the process involved in referring patients to a clinical trial. We also review the expenses that can be reimbursed.  There is a misperception that health insurance will deny certain costs, when in many states there are laws that mandate coverage of some of the costs.

And the third piece, which is essential, is to provide the infrastructure — the clinical trial nurse or clinical research assistant; the computers for data tracking; and a really well-designed and evaluated drug patient safety monitoring system for follow-up with patients who may experience side effects from any of the drugs that are being tested on the trial. By using this approach in a rural community, we’ve seen a 40-fold increase in clinical trial participation.

Do some of these same challenges exist for clinical trial recruitment for other diseases?

Absolutely. With diseases such as hypertension, that have less of a stigma than cancer, it may be somewhat easier to recruit patients, but nationally, there exists the need to foster greater diversity in clinical research participation.  At our institution, we have an umbrella organization, the Center for Health Disparities, that covers cancer, as well as other health disparity diseases, such as chronic kidney disease and cardiovascular disease. The enrollment in clinical trials in our academic setting, for example, in one of our chronic kidney disease studies, is 60 percent African American — which is incredibly high.

We’re doing many of the same things I described that have proven to be effective in the community setting. For example, we’re utilizing ministerial alliances where leaders of faith institutions come together in the fight against cancer. We train these leaders about clinical trials so that if a member of their congregation receives a cancer diagnosis, they can provide them with information about clinical trials and other important cancer treatment resources.

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For more information about Dr. Claudia Baquet’s research, go to: http://crchd.nci.nih.gov/initiatives/cnp/biographies/baquet.html.

To read more about the National Best Practice Initiative: http://phs.os.dhhs.gov/ophs/BestPractice/.

Animation/Video

View the Archived Webcast of NCI Science Writer’s Seminar, “Cancer Rates in Minority Populations” at NIH VideoCasting. The seminar was held on September 6, 2006.

Audio Clips

1. Dr. Claudia Baquet, M.D., discusses aspects of minority enrollment in clinical trials such as the Selenium and Vitamin E Cancer Prevention Trial, a clinical trial to see if one or both dietary supplement can reduce the risk of prostate cancer in high risk patients such as African American males.

      ( Audio – Length: 00:48 – 308kb )

   Text Transcript

   Dr. Claudia Baquet, M.D., discusses aspects of minority enrollment in clinical trials such as the Selenium and Vitamin E Cancer Prevention Trial, a clinical trial to see if one or both dietary supplement can reduce the risk of prostate cancer in high risk patients such as African American males.

   For example, in the SELECT trial [the Selenium and Vitamin E Cancer Prevention Trial, a clinical trial to see if one or both dietary supplement can reduce the risk of prostate cancer in high risk patients such as African American males. While national accrual to this study went well, patients who had uncontrolled hypertension were not eligible and were excluded. Well, some of the communities that are at most risk for higher incidence for prostate cancer also have a higher prevalence of hypertension. So minority populations can be restricted from clinical trials just because of how the trial is designed and eligibility criteria developed. Other conditions that may preclude people from participating in trials include diabetes, peripheral arterial disease, and chronic pulmonary disease. It depends on the trial design and criteria.

2. Dr. Claudia Baquet, M.D., discusses the importance of clinical research and clinical trials.

      ( Audio - Length: 00:47 - 293kb )

   Text Transcript

   Dr. Claudia Baquet, M.D., discusses the importance of clinical research and clinical trials.
   Clinical research is a critical resource for the development of new prevention, diagnosis, and treatment techniques for a number of diseases, including cancer. Whether one can trust and apply the results of a clinical trial as well as transfer them into clinical practice is related to the type and the numbers of patients that are enrolled in the trial. If a trial does not include minorities, then there's a question of whether or not the results of the studies are relevant to everyone across the board.

Photos/Stills

1. Comparison of U.S. death rates due to heart disease vs. those due to cancer

2. Map of NCI's SEER [Surveillance Epidemiology and End Results] sites that are used for sampling cancer rates in the U.S.

3. Incidence and mortality rates for major minority populations in the U.S.