Rule of three (medicine)

Rule of three (medicine)

The rule of three states that, if no major adverse events occurred in a clinical trial of a drug, then there can be 95% confidence that major adverse events do not happen more often than one in n/3 people, where n is the number of people in the study. This is based on an asymptotic result of risk estimation, and is valid where n>30.

For example, in a trial of a drug for pain relief in 1500 people, none have a major adverse event. The rule of three says we should have 95% confidence that the rate of adverse events is no more frequent than 1 in 500.

This rule is useful in the interpretation of drug trials, particularly in phase 2 and phase 3, which frequently do not have the statistical power or duration to find the relationship between the intervention and adverse events. They are designed to test the effectiveness of a drug, and often the discovery of adverse events is not in the interests of the sponsors.

Cite journal
volume = 311
issue = 7005
pages = 619-620
last = Eypasch
first = Ernst
coauthors = Rolf Lefering, C K Kum, Hans Troidl
title = Probability of adverse events that have not yet occurred: a statistical reminder
journal = BMJ
accessdate = 2008-04-15
date = 1995-09-02
url = http://www.bmj.com


Wikimedia Foundation. 2010.

Игры ⚽ Нужно сделать НИР?

Look at other dictionaries:

  • Rule of Three — may refer to: *Rule of three (medicine), judgement of likelihood of harm in drug trials. *Rule of three (Wiccan), a tenet of Wicca *Rule of three (mathematics), a computation method in mathematics *Rule of three (writing), a principle of writing… …   Wikipedia

  • Medicine and Canon Law — • In the early centuries the practice of medicine by clerics, whether secular or regular, was not treated with disapproval by the Church, nor was it at all uncommon for them to devote a considerable part of their time to the medical avocation.… …   Catholic encyclopedia

  • MEDICINE AND LAW — This article is arranged according to the following outline: introduction Judicial Decision – A Value Determination the values of a jewish and democratic state in the image of god PHYSICIAN S DUTIES AND PATIENTS RIGHTS the physician and the judge …   Encyclopedia of Judaism

  • MEDICINE — From the beginning of their history until modern times Jews have exercised a tremendous influence on the development of medical science. They have always been solicitous in their care for the sick and held the medical profession in great esteem.… …   Encyclopedia of Judaism

  • medicine, history of — Introduction  the development of the prevention and treatment of disease from prehistoric and ancient times to the 20th century. Medicine and surgery before 1800 Primitive (primitive culture) medicine and folklore       Unwritten history is not… …   Universalium

  • medicine — /med euh sin/ or, esp. Brit., /med seuhn/, n., v., medicined, medicining. n. 1. any substance or substances used in treating disease or illness; medicament; remedy. 2. the art or science of restoring or preserving health or due physical condition …   Universalium

  • Medicine — This article is about the science and art of healing. For pharmaceutical drugs, see Medication. For other uses, see Medicine (disambiguation). Statue of Asclepius, the Greek god of medicine, holding the symbolic Rod of Asclepius with its coiled… …   Wikipedia

  • Bartholomews rule of fourths — if the uterine fundus is one fourth of the way from the pubic symphysis to the umbilicus, the pregnancy is of two months duration; one half of the way, three months duration; three quarters of the way, four months duration; at the umbilicus, five …   Medical dictionary

  • Nдgele rule — to predict the first day of labor and confinement, subtract three months from one year after the first day of the last menstruation and add seven days …   Medical dictionary

  • History of Medicine —     History of Medicine     † Catholic Encyclopedia ► History of Medicine     The history of medical science, considered as a part of the general history of civilization, should logically begin in Mesopotamia, where tradition and philological… …   Catholic encyclopedia

Share the article and excerpts

Direct link
Do a right-click on the link above
and select “Copy Link”