Sage Journals: Discover world-class research

Abstract

The early detection and improved understanding of adverse reactions caused by therapeutic drugs is vital to the safety of medical practice. In his recent valuable survey of the problems of pharmacoepidemiology, and after comment on the importance of metanalyses of clinical trials, Rawlins (1) stated that comparable: “overviews of safety problems … have yet to be secured by a robust statistical methodology.” As in other disciplines, many established biometric techniques are available for use, but these usually rest upon conditions relating to the source and ascertainment of data that are not fulfilled by informally acquired and spontaneously submitted records. Has not the time arrived for renewed efforts to test alternative methods of data acquisition, and to incorporate the best of these into national measures for drug safety?

Keywords

Pharmacoepidemiology Adverse reactions Statistics

Get full access to this article

View all access options for this article.

References

Rawlins

. The challenge to pharmacoepidemiology. Pharmacoepidem Drug Saf. 1995;4:5–10.

Finney

. The design and logic of a monitor of drug use. J Chron Dis. 1965;18:77–98.

Finney

. Monitoring adverse reactions to drugs —Its logic and its weaknesses. Proceedings of the European Society for the Study of Drug Toxicity. 1966;7:198–207.

Inman

WHW

Rawson

NSB

Wilton

. In: Monitoring for Drug Safety. 2nd ed. Lancaster, England: MTP Press:1985.

Doll

Skegg

DCG

. The case for recording events in clinical trials. Br Med J. 1977;2:1523–1524.

Inman

WHW

. Thirty years in post-marketing surveillance: a personal perspective. Pharmacoepidem Drug Saf. 1993;2:239–257.

Inman

WHW

Vessey

Westerholm

Engelund

. Thromboembolic disease and the steroid content of oral contraceptives. Br Med J. 1970;2:203–209.

Finney

. Statistical logic in the monitoring of reactions to therapeutic drugs. Meth Inf Med. 1971; 10:237–245.

Finney

. Systematic signalling of adverse reactions to drugs. Meth Inf Med. 1974;13:1–10.

10.

Mandel

SPH

Levine

Beleño

. Signalling increases in reporting in international monitoring of adverse reactions to therapeutic drugs. Meth Inf Med. 1976;15:1–10.

11.

Moussa

MAA

. On Statistical Monitoring of Adverse Reactions to Drugs. PhD Thesis, University of Edinburgh; 1976.

12.

Bégaud

Moride

Haramburu

. Quality improvement and statistical calculations made on spontaneous reports. Drug Inf J. 1994;28:1187–1195.

13.

Fisher

. The Design of Experiments. 1st ed. Edinburgh, Oliver & Boyd; 1935.

Statistical Aspects of Pharmacoepidemiology

Abstract

Keywords

Get full access to this article

References