Ethical Issues in Clinical Trials
An Overview of Contemporary History
Clinical trials are experiments on human subjects--which means that ethical issues are always present. This article surveys historically prominent ethical debates.
A clinical trial is a form of experimentation on a population of human subjects. These experimental subjects are randomly assigned to either the group to receive the experimental intervention, or the group(s) that receive either an already established treatment or a placebo. Researchers then try to determine whether the differences in observed outcomes for each group are sufficiently different for it to be very unlikely that this difference could have occurred by chance. Because clinical trials involve experimentation on human beings, ethical issues are always present.
During World War II, Sir Austin Bradford Hill designed what many regard as one of the first truly modern clinical trials because Hill employed the technique of randomization in assigning the study participants to the treatment groups. The newly developed drug streptomycin looked promising as a treatment for tuberculosis, but the drug had not yet been produced on a widespread scale. Given this shortage, Hill and his associates felt that it was ethical to carry out this trial—with a control group of patients who would not receive the drug--in order to definitively answer the scientific question of the drug’s merit.
In the 1960s and 1970s, governments began to require that clinical trials be performed to establish that drugs worked before they could be marketed by the pharmaceutical industry. One of the main catalysts that led to this development was the tragedy of infants being born with deformities to women who took the drug thalidomide during pregnancy in the late 1950s and early 1960s. Here again, ethical issues are in play—the governments were mandating that clinical trials be performed in order to serve the ethical end of promoting public safety.
In the 1980s, the new disease of AIDS led the United States government to rethink its policy on drug approval. AIDS patients became political activists and argued that they should have access to these potentially life-saving therapies—even though these drugs were still experimental. In this political environment, the government requirement of proof of efficacy seemed paternalistic. The AIDS patients were invoking a different ethical principle-- namely, their right to self determination.
In the 21st century, new ethical issues surrounding clinical trials are on the horizon. For the sake of transparency and greater patient safety, there are now calls by the World Health Organization for the data from all trials—including trials conducted by private pharmaceutical companies—to be published in a clinical trial registry. As drug companies have become multinational in orientation, there are increasing fears that clinical trials will be “exported” to parts of the world with large poor populations such as India; in effect, populations in these parts of the world may become guinea pigs on which to test therapies, which will later be used by inhabitants of richer and more developed countries. From this perspective, contemporary issues in the design of clinical trials could be seen as an issue of global justice.
