Drug Trial in India
A Johns Hopkins University scientist tested experimental cancer drugs on patients in India without required federal or university approvals and without adequate preliminary tests in animals, a faculty investigative committee has found.
The committee, appointed last summer to investigate allegations regarding the clinical trial, submitted its report to Richard E. McCarty, the dean of the university's Krieger School of Arts and Sciences.
McCarty accepted the report and has barred the scientist from serving as principal investigator on any future research involving human subjects. The dean also required that any future participation by the scientist in human studies, led by other principal investigators, must be supervised by a senior faculty member with expertise in clinical research from either the university's School of Medicine or its Bloomberg School of Public Health. The dean also imposed other oversight requirements and limitations on the scientist's work.
The scientist, a faculty member in the School of Arts and Sciences, has the option to appeal to the vice provost for research. The university is reporting the results of the investigation to the U.S. Food and Drug Administration, the Office of Research Integrity of the National Institutes of Health and the Office for Human Research Protections of the Department of Health and Human Services.
The investigation involved a study of two experimental cancer drugs conducted by the Hopkins scientist, as principal investigator, and Indian collaborators. The trial at the Regional Cancer Center in the southern India state of Kerala, involving 26 oral cancer patients, ran from November 1999 to April 2000. In July 2001, reports appeared in the Indian news media of complaints by physicians there that the trial had been improperly conducted.
The Johns Hopkins faculty committee found that:
* The scientist was negligent for failing to submit a proposal for the clinical trial to a Johns Hopkins University institutional review board. Under university policy and federally mandated procedures, faculty experiments involving human subjects must have prior IRB approval, whether conducted in the United States or abroad.
* The trial did not meet Johns Hopkins standards for research with human subjects. For example, the committee found there was inadequate safety testing of the drugs in animals before they were injected into human patients. The committee also said that consent forms used to recruit patients for the study were inadequate.
* The scientist carried drugs used in the study to India without either an "investigative new drug" approval from the Food and Drug Administration or explicit FDA export permission.
* The scientist, without authority, signed several versions of a document committing the university to collaboration with the RCC.
The committee said it found no evidence that any patient had been harmed or that any patient's conventional treatment was delayed by the clinical trial.
The committee report also criticized the university's initial handling of the case. It said that an inquiry should have begun in March 2001, when the university -- which had earlier been aware of the 1999-2000 trial -- first learned that the scientist had run it without university IRB approval. Assured by the scientist that ethics committee approval had been received in India, the university did not begin an inquiry then but instead counseled the scientist that all future human studies had to be submitted to a Hopkins IRB. An inquiry began in July, when the university learned of the allegations concerning the conduct of the trial in India.
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