Clinical Research, the controlled use of humans in medical experiments, dates from the Greek physician Galen (c. 129–199), the founder of experimental medicine. Clinical research in the United States, however, rose in importance in the late nineteenth century following European advances in Medical Research. In 1884, disease investigators in the United States formed the American Clinical and Climatological Association, and in 1909, medical experimenters established the American Society of Clinical Investigation, which promoted correlation of clinical research with medical practice. For much of the twentieth century clinical researchers investigated the safety and effectiveness of diagnosis, prevention, and treatment of human diseases and disorders. Usually, but not always, basic laboratory research and animal experimentation preceded human testing.

In the twentieth century, clinical research increased with the expansion of military medical research, the growth of academic medical science, the rise of pharmaceutical companies, and the establishment of private research clinics. As a result of the 1906 Pure Food and Drug Act and its subsequent amendments, new drugs underwent clinical testing prior to widespread use by physicians. The importance of clinical research grew significantly after the establishment of the National Institute of Health (NIH) in 1930 and NIH expansion to multiple institutes after World War II. By then, the Public Health Service, which included the Food and Drug Administration and the NIH, was probably the most generous supporter of clinical research in the country. In 1953, the NIH opened the largest clinical research center in the nation in Bethesda, Maryland.

Following World War II, the Nuremberg Code, drawn up after revelations of brutal experiments on humans by the Nazis, exerted significant influence on clinical researchers in the United States. The code limited the degree of risk in clinical research to a level that would not exceed that determined by the humanitarian importance of the problem to be solved by the experiment. Subsequently, many institutions used the code as ethical guidance. In 1962, Congress enacted the first federal law regulating human medical experimentation. After learning that thalidomide had caused the birth of deformed babies in Europe, the legislators amended the Food and Drug Act to require that patients be informed that they were being given experimental drugs not fully licensed by the federal government.

Later in the century, clinical research came under fire because of revelations about the federal government's neglect of women, minorities, and the elderly in clinical trials; radiation experiments on humans, especially those lacking informed consent; and charges of fraud. Congress responded in 1993 by passing the NIH Health Revitalization Act to correct the imbalance of women and minorities in clinical research. Subsequently the NIH launched the largest clinical health trial in the history of the United States by selecting 63,000 women for a nine-year trial to determine the effects of certain regimens on preventing cancers, osteoporosis, and coronary heart disease. Congress and the executive branch also investigated charges of impropriety in conducting potentially harmful radiation exposure experiments on humans and allegations of fraud.

Despite the controversies, the nation has benefited from clinical research. Trials in the 1970s showed that lowering blood cholesterol diminished chances of heart disease in men. In The 1980s, clinical research saved patients with soft tissue sarcomas of the limbs from amputations by demonstrating the effectiveness of radiation therapy and chemotherapy combinations. And in the late 1980s, clinical tests indicated that azidothymidine (AZT), an antiviral drug, could slow down the development of AIDS in some patients.

Bibliography

Annas, George J., and Michael A. Grodin, eds. The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. New York: Oxford University Press, 1995.

Grady, Christine. The Search for an AIDS Vaccine: Ethical Issues in the Development and Testing of a Preventive HIV Vaccine. Bloomington: Indiana University Press, 1995.

Marks, Harry M. The Progress of Experiment: Science and Therapeutic Reform in the United States, 1900–1990. New York: Cambridge University Press, 1997.

Mastroianni, Anna C., Ruth R. Faden, and Daniel Federman, eds. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies. 2 vols. Washington, D.C.: National Academy Press, 1994.

McNeill, Paul M. The Ethics and Politics of Human Experimentation. New York: Cambridge University Press, 1993.

—Ruth Roy Harris/C. P.