A review of patient outcomes in pharmacological studies from the psychiatric literature, 1966–1993 [Book Review]
Science and Engineering Ethics 3 (4):395-406 (1997)
A literature search was conducted on studies of new drugs used with patients with schizophrenia reported by U.S. and non-U.S. researchers from 1966–1993, yielding 41 U.S., and a total of 24 other non-U.S. studies, among them 11 British studies. Results of the U.S. and non-U.S. studies were pooled separately and compared. Among several comparable conditions discussed, the lack of any data on suicides in the U.S. studies was observed. For a second statistical analysis of suicide rates ‘person-years’ were calculated to adjust for differing washout durations. The results obtained include findings that the percentage of patients relapsing in U.S. studies was slightly lower than in non-U.S. studies ; the percentage of patients dropping out in U.S. studies was higher than in non-U.S. studies ; known location of dropout patients in U.S. studies was 1.7%, compared to 2.6% in non-U.S. studies. The most interesting finding was that no suicides were reported in U.S. studies, compared to 0.6% of patients reported in British studies. Some U.S. studies used ‘challenge doses’, such as amphetamines or L-dopa; no non-U.S. studies reported their use. Compared to U.S. studies, those by non-U.S., and particularly British, researchers appeared to report adverse events in their studies. ‘Challenge’ drugs were not used; suicides were reported. It is estimated that the probability that no patients suicided who participated in the U.S. is small—one in 500
|Keywords||clinical research ethics protocol design informed and proxy consent schizophrenia relapses suicides integrity of research data Institutional Review Boards|
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References found in this work BETA
A Trial Policy for the Intramural Programs of the National Institutes of Health: Consent to Research with Impaired Human Subjects.John C. Fletcher, F. William Dommel & Daniel D. Cowell - forthcoming - IRB: Ethics & Human Research.
Ethical Concerns About Relapse Studies.Adil E. Shamoo & Timothy J. Keay - 1996 - Cambridge Quarterly of Healthcare Ethics 5 (3):373.
Informed Consent Legal Theory and Clinical Practice.Paul S. Appelbaum, Charles W. Lidz & Alan Meisel - 1987
Citations of this work BETA
Fostering Integrity in Research: Definitions, Current Knowledge, and Future Directions. [REVIEW]Nicholas H. Steneck - 2006 - Science and Engineering Ethics 12 (1):53-74.
A Case for a Duty to Feed the Hungry: GM Plants and the Third World.Lucy Carter - 2007 - Science and Engineering Ethics 13 (1):69-82.
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