[Forum SIS] Seminario DiSIA: Massimo Attanasio

[Raffaele Guetto]

DiSIA (Dipartimento di Statistica, Informatica, Applicazioni "G.
Parenti")
Università di Firenze

- PROSSIMO SEMINARIO - 

26 Febbraio 2019 ore 12.30

MASSIMO ATTANASIO (Università degli Studi di Palermo) terrà il seguente
seminario:  

Evidence of bias in randomized clinical trials of hepatitis C interferon
therapies 

INTRODUCTION: Bias may occur in randomized clinical trials in favor of
the new experimental treatment because of unblinded assessment of
subjective endpoints or wish bias. Using results from published trials,
we analyzed and compared the treatment effect of hepatitis C antiviral
interferon therapies experimental or control. 
METHODS: Meta-regression of trials enrolling naive hepatitis C virus
patients that underwent four therapies including interferon alone or
plus ribavirin during past years. The outcome measure was the sustained
response evaluated by transaminases and/or hepatitis C virus-RNA serum
load. Data on the outcome across therapies were collected according to
the assigned arm (experimental or control) and to other trial and
patient-level characteristics. 
RESULTS: The overall difference in efficacy between the same treatment
labeled experimental or control had a mean of + 11.9% (p < 0.0001). The
unadjusted difference favored the experimental therapies of group IFN-1
(+ 6%) and group IFN-3 (+ 10%), while there was no difference for group
IFN-2 because of success rates from large multinational trials. In a
meta-regression model with trial-specific random effects including
several trial and patient-level variables, treatment and arm type
remained significant (p < 0.0001 and p = 0.0009 respectively) in
addition to drug-schedule-related variables. 
CONCLUSION: Our study indicates the same treatment is more effective
when labeled "experimental" compared to when labeled "control" in a
setting of trials using an objective endpoint and even after adjusting
for patient and study-level characteristics. We discuss several factors
related to design and conduct of hepatitis C trials as potential
explanations of the bias toward the experimental treatment.

Referenti: Alessandra Petrucci e Carla Rampichini

Il seminario sara' tenuto presso l'aula 32 del DiSIA, Viale Morgagni 59,
50134 Firenze.

Tutti gli interessati sono cordialmente invitati a partecipare. 
-- 
RAFFAELE GUETTO
_University of Florence - Department of Statistics, Computer Science,
Applications_
Viale Morgagni, 59 - 50134 Firenze
Tel: +39 055 2751553
Web:
https://www.disia.unifi.it/p-doc2-2017-000000-G-3f2c342938302c-0.html
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