- Sample size calculations for risk equivalence testing in pharmacoepidemiologyP Tubert-Bitter
INSERM Unite 472, Epidémiologie et Biostatistique, 16 Avenue Paul Vaillant Couturier, 94807 Cedex, Villejuif, France
J Clin Epidemiol 53:1268-74. 2000..This approach is the appropriate way to conclude equivalence, rather than the commonly used approach of difference testing and concluding equivalence when the null hypothesis of equality is not rejected...
- A nonparametric comparison of the effectiveness of treatments: a multivariate toxicity-penalized approachPascale Tubert-Bitter
INSERM U 472, Villejuif, France
J Biopharm Stat 15:129-42. 2005..Data from a randomized clinical trial of patients with metastatic nonseminomatous germ cell tumors are used to illustrate the method...
- Two-treatment comparison based on joint toxicity and efficacy ordered alternatives in cancer trialsAlexia Letierce
INSERM U472, 16, avenue Paul Vaillant Couturier, 94807 Villejuif Cedex, France
Stat Med 22:859-68. 2003..Our approach is illustrated with a multi-centre randomized clinical trial involving patients with metastatic non-seminomatous germ cell tumours...
- Testing independence between two Poisson-generated multinomial variables in case-series and cohort studiesMounia Hocine
Institut National de la Sante et de la Recherche Medicale, Unité 472, Villejuif, France
Stat Med 24:4035-44. 2005..Simulations for checking the validity of the test concerning the type I error and the power properties are presented. The test is illustrated using data from a cohort on antibiotics bacterial resistance in schoolchildren...
- The safety of drugs for OTC use: what evidence is required for an NSAID switch?Thomas M MacDonald
Medicines Monitoring Unit, Ninewells Hospital and Medical School, Dundee DD1 9SY, UK
Pharmacoepidemiol Drug Saf 11:577-84. 2002..2 with at least 90% power for an event rate of 5%. An example of a possible pharmacy-based randomized study design to demonstrate safety equivalence of OTC analgesics is given...
- An easy to use method to approximate Poisson confidence limitsBernard Begaud
Department de Pharmacologie, Universite Victor Segalen, 33076 Bordeaux Cedex, France
Eur J Epidemiol 20:213-6. 2005..It allows computation of Poisson confidence limits both for count or rates and proportions...
- Trends in spontaneous adverse drug reaction reports to the French pharmacovigilance system (1986-2001)Frantz Thiessard
EA3676, IFR99, Universite Victor Segalen Bordeaux 2, 146 rue Leo Saignat, 33076 Bordeaux Cedex, France
Drug Saf 28:731-40. 2005..The objective of this study is to describe the characteristics of the reports and the reporting trends in the French pharmacovigilance spontaneous reporting database from 1986 to 2001...
- A combined superiority and non-inferiority approach to multiple endpoints in clinical trialsDaniel A Bloch
HRP Biostatistics, Stanford University, Stanford, CA 94305, U S A
Stat Med 26:1193-207. 2007....
- Detection of emerging diseases in occupational health: usefulness and limitations of the application of pharmacosurveillance methods to the database of the French National Occupational Disease Surveillance and Prevention network (RNV3P)Vincent Bonneterre
Faculte de Medecine, Domaine de la Merci, 38706 La Tronche Cedex, France
Occup Environ Med 65:32-7. 2008..To test data mining methods used in pharmacosurveillance in order to identify potential emerging disease-nuisance associations in the national occupational disease surveillance and prevention network (RNV3P) database...