@article{129c132da86c4cd1adff454ba7b9bad7,
title = "Monitoring adverse reactions to new drugs: “restricted release” or “monitored release”?",
author = "Lawson, \{D. H.\} and Henry, \{D. A.\}",
note = "Funding Information: and to conduct the detailed studies would be open to discussion. While it could be a subgroup of the Committee on Safety of Medicines, one of the royal colleges, or a pharmaceutical firm, none of these would be ideal. An independent body funded by a central grant and located within a university precinct would have certain attractions, as would a body run by either the Pharmaceutical Society or the Association of the British Pharma-ceutical Industry. The detailed studies needed would essentially be case-control studies giving information on death, admission to hospital, or outpatient consultations in the study cohort (the cases) and controls. Selection of controls would depend on the nature of the hypothesis being tested. The data could be assessed annually for five years after introduction of the drug and additionally if specific anxiety was raised about possible toxic effects. The information would be obtained directly from the patient's general practitioner and, since it could be obtained readily by scrutiny of the patient's record card, might well be done without the necessity of incurring a fee. No contact with the patient would be necessary for this evaluation.",
year = "1977",
month = mar,
doi = "10.1136/bmj.1.6062.691",
language = "English",
volume = "1",
pages = "691--692",
journal = "British Medical Journal",
issn = "0007-1447",
publisher = "BMJ Publishing Group",
number = "6062",
}