Subject Diversity Is Good for the Business of Medicine

April 1, 2005

Applied Clinical Trials

With the advent of personalized medicine and purported "race-based therapies" such as BilDil in the news, it is time the pharmaceutical industry makes a more concerted effort to engage racial and ethnic minority groups and the rural poor in clinical research.

With the advent of personalized medicine and purported "race-based therapies" such as BilDil in the news, it is time the pharmaceutical industry makes a more concerted effort to engage racial and ethnic minority groups and the rural poor in clinical research.

Joseph F. West

For some time, the industry has recognized the need to do a better job engaging disparate communities in clinical research. There have been some steps forward in this area, such as the FDAMA Act of 1997. However, they have fallen short: minority group representation in clinical trials remains substantially below population proportions. The poor, particularly the rural poor, are also inadequately represented.

Some differences in drug response have been observed in certain groups in the United States. These differences may be attributable to intrinsic factors such as genetic variability, to extrinsic factors like environmental exposures, diet, or socio-cultural variables, or they may result from an interaction between all such factors.

The more diverse the subject pool, the more likely we would be able to disentangle these factors in analysis. This could lead to firmer outcomes that better highlight the potential benefits, as well as adverse effects, of a particular medical product or device. Race itself is not a good proxy for genetic and environmental factors. Thus, demographics in protocols should thoroughly capture as many of these factors as possible in a valid and reliable manner.

Trust

The first step is building trust. Distrust of the clinical research community is rooted in past negative experiences with clinical trials, such as the Tuskegee Syphilis Experiments, for example. For 40 years between 1932 and 1972, the U.S. Public Health Service (PHS) conducted an experiment on 399 African-American men in the late stages of syphilis. The participants, who were mostly poor sharecroppers, were not told they had the disease. Doctors did not treat the participants, in order to observe the destructive final stages of the disease. The experiments at Tuskegee continue to resonate not only with African-Americans, but also with other minority groups and the rural poor, as abuses of power by researchers and the government.

Solidifying trust in medical research among these groups will go a long way towards maintaining the public's confidence in medicine, given recent coverage. All persons approached to participate in a clinical trial, regardless of ethnicity or class, must be assured that researchers will treat them with respect and protect both the subject's and site's integrity.

Communication

The second step would be to improve the ways and means of communicating to certain groups. While following federal guidelines for protocols and applications concerning communications, research sites should creatively consider that some groups may have literacy issues, or that English may not be their first language. Employing audio or visual aids to support information conveyance can prove effective and time saving in these situations.

In addition to communicating the basics of the research process, we should learn ways to communicate more about ourselves. This does not necessarily mean discussing our personal lives, but it does mean working on ways to express our appreciation, respect, and empathy. Because a majority of studies require physiological and psychological access, as well as time and energy, our ability to connect to people who may already consider themselves as vulnerable is important.

Communicating more directly helps keep channels open, so at least there does not appear to be a veil between researcher and subject. This could lead to better retention and subject compliance.

Cultural competency

Finally, each site should develop core competencies about subjects' socio-cultural environment, and the kinds of economic and social challenges they may face, that could hinder their participation. It is also important to have an understanding of certain groups' distinct experiences with the health care system. Those experiences help shape perceptions of researchers or sites, which could predispose subjects' negatively approaching the trial process.

Diversity enriches the clinical research environment and makes for better therapies and devices. Getting to where these populations are will take commitment and ingenuity.