Questions on the exclusion of African-American patients in study P03659 (NCT00160251)

An open letter to Schering-Plough:

I am writing to inquire about the study design of your phase 2 trail of the drug SCH 503034 in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis. According to clinicaltrials.gov, this trial excludes, among others, "patients with cirrhosis, co-infection with Hepatitis B or HIV, and African-American patients." As a geneticist and bioethicist, I have difficulty understanding why African-American patients are being excluded from this trial, particularly since that is the only ethnic group specifically excluded.

Excluding African-Americans will not lead to greater genetic homogeneity as 85% of genetic diversity is found within population groups. In addition, genetic, anthropological and other data show that individuals and populations vary along worldwide gradients rather than clustering into distinct "races."

Social and biological scientists have raised numerous concerns about the difficulties faced in defining a particular ethnic group, with "African-American" being particularly contentious. How are you defining "African-American" in your trial? How does your definition relate to the medical and biological phenomena being studied in the trial?

If you are excluding African-Americans for social or other nonbiological reasons, it would be useful to specifically define those exclusion criteria. That information could be used to exclude non-African-Americans who do meet the exclusion criteria, and include African-Americans who do not and otherwise qualify. Does your full-length protocol define such criteria for which 'African-American' is presumably used as a proxy? If so, are there reasons why this information is collapsed into the term 'African-American'?

The National Institutes of Health Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research states that

"women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant Institute/Center Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research."

Although your work is not supported by the NIH, I and others would like to know your compelling reason for excluding African-Americans.

Given the benefits and risks associated with participation in clinical trials, it is critical that only relevant criteria are used to exclude and include participants. I have called the Schering-Plough office at 908-298-7409 to raise these questions and concerns and look forward to your prompt reply. Thank you for your assistance in this matter.

Sincerely,

Karama C. Neal, PhD MA