Medical Device Daily Staff Contributor
WASHINGTON The under-representation in clinical trials of specific populations, such as racial and ethnic minorities, women, the elderly, disabled persons, and those living in rural populations, is at direct odds with the current state of medical science and drug discovery, which is increasingly moving closer to personalized medicine, a group of researchers and physicians argue in a new report.
They say that despite years of discussion and the implementation of federal and state policies and guidelines designed to expand inclusion of such groups, the exclusions persist. They put this problem largely on drugmakers that fund the majority of clinical trials drugmakers and the inconsistency of policies between the FDA and the National Institutes of Health. But device trials also are marked by a focus on white male populations.
The group,behind an initiative known as Eliminating Disparities in Clinical Trials (EDICT), has conceived a plan that involves the government, industry, healthcare and communities to to ensure that those patients who are most representative of the diseases being studied are included in the trials.
More than 300 federal and state public health officials, medical researchers and patient advocates have come together with the Chronic Disease Prevention and Control Research Center and the Intercultural Cancer Council of Baylor College of Medicine (Houston) to develop the plan, outlined in a 34-page report.
During a media briefing this week at the National Press Club, Armin Weinberg, professor at the college of medicine and EDICT's principal investigator, said that the point is not "to reinvent the wheel" but rather to build on work already underway by others, such as the Robert Wood Johnson Foundation (Cambridge, Massachusetts), the Society for Women's Health Research (Washington) and the National Research Center for Women & Families (Washington), and bring some new approaches to the issue of study disparities.
James Powell, principal investigator for the Increasing Minority Participation and Awareness in Clinical Trials initiative of the National Medical Association, (Washington) aimed at educating physicians to become clinical trial investigators and informing communities about the value of medical research said that though Congress passed the NIH Revitalization Act in 1993, requiring the inclusion of women and minorities as participants in federally funded clinical research, these groups continue to be under-represented in clinical studies.
Among those who participated in clinical trials to test new cancer drugs from 1995 to 1999, less than 10% were African-Americans, Asian-Pacific Islanders, Hispanics and Native Americans, according to the FDA. In the publicly funded cancer clinical trials conducted from January 2003 to June 2005, only 8% were black, 5.6% were Hispanic, 2.8% were Asian-Pacific Islander and less than 1% were Native American, according to the National Cancer Institute.
In medical devices, the cardiovascular sector is the arena most often cited as not involving women, a critical absence given the differences between men and women concerning the presentation of heart disease symptoms.
Powell said that though the FDA Modernization Act of 1997 includes guidelines on standardizing data collection of racial and ethnic groups in clinical trials, it does not address what racial and ethnic inclusion is appropriate; and that while the FDA's 2005 clinical trials guidance document calls for study sponsors to document race and ethnicity of patients, it does not address the level of participation.
The FDA, according to the EDICT report, "views the NIH as the sole agency responsible for addressing disparities in clinical trials" and that drug regulators do not evaluate whether a clinical trial is inclusive of women, minorities or other under-represented groups in its medication approval process.
Without a requirement from the FDA to include women, minorities and other under-represented groups in all clinical trials not just those funded by the federal government "you are starting from a difficult situation," said Diana Zuckerman, president of the National Research Center for Women & Families.
Congress should consider further legislation that would require drugmakers to include under-represented groups in clinical trials, Weinberg said. He noted that a group from the EDICT initiative was meeting Tuesday with some Texas lawmakers or their staffers to discuss the report.
The group is calling for a reinvigoration of federal policies and regulation, including a proposal for the NIH to provide more detailed instruction on appropriate inclusion plans for under-represented populations in clinical trials, with substantial incentives for investigators to implement such plans.
In addition, the FDA needs to "harmonize" its inclusion policy with the NIH and implement penalties for sponsors of clinical trials that fail to comply with those policies, the EDICT report authors insisted. They added that drug regulators also should create incentives for study investigators to include racial and ethnic groups in trials.
Because of past unethical study practices, such as the notorious Tuskegee Study of Untreated Syphilis in the Negro Male, in which 399 poor and mostly illiterate black males were denied treatment for syphilis during a 40-year experiment, and the sterilization campaign of Hispanic women in New York's Spanish Harlem, many minority groups have a fear of the medical establishment, said Venus Gines, a cancer survivor and founder of Dia de la Mujer Latina Inc.
Therefore, she said, recruiting minorities for trials is best done through a person's own trusted physician, who speaks the same language as the patient and is familiar with or was raised in a similar cultural background.
Phyllis Greenberger, president/CEO of the Society for Women's Health Research has said that there need to be different approaches to the non-white male patient populations. "Your method of approach has to be tailored to the people you want to get the message to," she told one of MDD's sister publication earlier this year (Biomedical Business & Technology, "BB&T interview," January 2008).
Some of the barriers to inclusiveness include confusing paperwork, language differences and the failure to implement guidelines for improving the accessibility of clinical settings, the EDICT report says.
Members of institutional review boards (IRBs), which are required to approve the research design and protocol and maintain oversight of a clinical trial, often lack the training needed to recognize how disparities may manifest themselves in research protocols, the EDICT authors maintained. Thus, they said, IRBs regularly approve research protocols that do not provide for inclusion of under-represented populations.
In addition, the EDICT report asserts that although medical journals have developed explicit policies for articles and have been on the forefront in advancing issues such as improved reporting practices for clinical trials, discussions of diversity, inclusion and representation in medical studies are rarely reported in published studies.
Ensuring that women, the elderly, minorities and other groups are included in clinical trials is more than a question of fairness, said Barbara Pence, professor of pathology at Texas Tech University Health Science Center School of Medicine. Having different types of people included in a study, she said, can ensure that effective treatments are directed at the right populations, rather than a one-size-fits-all approach that extrapolate to unstudied groups and can result in treatment harm.