An Empirical Analysis on the European Market of Human Experimentation

The target of this work is to support the thesis that pharmaceutical companies' testing phase would be treated like any other form of production in a globalization process, that is to say, a specific phase of pharmaceutical R&D could be localized where the cost of clinical evidence is lower. Considering Europe, an empirical analysis in order to support the main hypothesis is performed. Taking trials of phases II and III, funded by Industry (dependent variable) and the main macroeconomic features (independent variables) of each nation into account, the empirical work is implemented via regression analysis on panel data (2000 - 2007). The sample analyzed considers EU-27 plus the candidate states (Croatia, the Former Yugoslav Republic of Macedonia, Turkey), Norway, Switzerland and Iceland. Results suggest the appropriateness of this process since clinical research is clearly affected by economic conditions, regardless of the scientific purpose.Pharmaceutical Company R&D; Human experimentation; Medical Researcher; Research Subject;

L'incentivazione economica nei problemi di agenzia: il caso dell'Azienda Sanitaria Pubblica

Questo paper, rifacendosi a noti modelli micro-economici di agenzia (Holmstrom e Milgrom, 1991; Jirjahn, 2000; Mas-Colell, 1995), mostra quale sia, in condizioni d'incertezza ed informazione asimmetrica, la migliore politica correttiva adattabile ad una struttura sanitaria pubblica, in presenza di opportunismo post-contrattuale da parte del pubblico dipendente. L'ambiente descritto sara'  quello di un' Azienda Sanitaria Pubblica, in cui il rapporto di agenzia si svolgera'  tra il Direttore Generale della struttura (principale) ed un pubblico dipendente (agente) posto a svolgere il proprio servizio lavorativo presso il presidio ospedaliero, con rapporto di lavoro subordinato e dipendente. Il paper mostrera;  come, nonostante l'adozione di una politica d'incentivazione economica, non sempre sia raggiungibile una soluzione d'efficienza per i cittadini.

Institutional efficiency and budget constraints: a Directional Distance Function approach to lead a key policy reform

Working Paper Ircres-CNR 06/2021. This manuscript focuses on the Italian judicial system and on how to shape a policy reform aimed at increasing court efficiency, taking the financial negative externalities generated by this production process into account. On the one hand, the authors identify the benchmarks and main drivers of judicial inefficiency, while, on the other hand, they show how incorrect model definition may mislead policy makers tackling this reform process, based on an analysis of the Directional Distance Function with and without bad outputs. According to the results, incorrect model definition causes a type I error equal to 10.37% and a type II error equal to 3.66%. Policy implications concern the opportunity to adopt the proposed model and the collected benchmarks to reform the judicial system, improving its technical efficiency and maintaining the public budget under control

An analysis of how 2002 judicial reorganisation has impacted on the performance of the First Instance Courts (Preture) in Ticino

With data from 2001 to 2010 of the First Instance Courts of the Canton of Ticino, Switzerland, this paper examines the impact of Legge sull’istituzione della Pretura penale e della funzione di sostituto Procuratore pubblico (2002), which meant to improve Cantonal court performance by decreasing penal workload. Our results suggest that such law has posed non-positive effects on judicial length and courts’ performance. This work may furnish moreover some intuition about the expected impact of Legge sull’organizzazione giudiziaria (2006), which has adapted cantonal judicial system to new Swiss Civil Procedure Code, as well policy proposals for the cantonal programme known as Giustizia 2018

the localization of pharmaceutical clinical research in europe

Background: Clinical research is a specific phase of the production process in the pharmaceutical industry in which companies test candidate drugs on patients in order to collect clinical evidence about safety and effectiveness.Objective: This paper is an operational research which aimed to support the hypothesis that pharmaceutical clinical research is like any other production process which could be localized where the cost is most competitive. In other words, this work aimed to demonstrate that the localization process of this specific phase of the pharmaceutical industry's R&D is based on the price of clinical evidence.Methods: Considering Europe and taking panel data into account, an efficiency frontier through data envelopment analysis (DEA) was estimated. The efficiency of countries in maximizing the number of innovative medical treatments, given their available resources was estimated. Afterwards, focusing on European macro-regions, authors analyzed whether a significant concentration of clinical research exists.Results: Results suggest that, taking the expected principal investigators' fee into account, Southeastern Europe and Central Eastern Europe are the most attractive macro-regions for the pharmaceutical industry's foreign direct investments in clinical research.Conclusion: The results of the proposed operational research cannot reject the suggested evolution of the pharmaceutical industry's clinical research. In other words, results confirm the localization process of the testing phase in East Europe, where the expected principal investigators' fee is more competitive

Data Envelopment Analysis e sistemi sanitari regionali italiani

Il presente lavoro intende in prima battuta analizzare l'efficienza dei sistemi sanitari regionali sulla base della qualità percepita dai pazienti. Quest'ultima è stata calcolata sulla mobilità interregionale: flusso dei pazienti extra-regione (immigrati o mobilità positiva) confrontato con il flusso di quelli della regione stessa che escono per andare a farsi curare in un'altra (emigrati o mobilità passiva). Si ipotizza infatti che le persone si spostino dove percepiscono che la qualità sia migliore tenendo in considerazione la possibile influenza della rete sociale. Dopo aver ottenuto uno score di efficienza per ogni sistema sanitario regionale attraverso la metodologia della Data Envelopment Analysis è stato effettuato uno studio econometrico per verificare un'ulteriore ipotesi: può l'efficienza sanitaria regionale, così come concepita in questo lavoro, essere influenzata dal peso del settore pubblico? I risultati ottenuti suggeriscono che effettivamente il processo di privatizzazione della sanità regionale non porta a miglioramenti nel livello di qualità percepita dai pazienti.analisi regionale; efficienza; DEA; sistema sanitario; regional analysis; efficiency; DEA; medical care system

Transaction costs and pharmaceutical clinical research, a Data Envelopment Analysis approach

WP 04/2012; Taking human experimentation into account, this work aims at estimating the relationship between transaction costs, which are related to the protection system of patients’ rights, and localization of pharmaceutical industry’s testing phase. Assuming that the competitiveness of the protection system is based on the time required to obtain an authorization for an experimental activity, pharmaceutical clinical research should be positively affected by a process aimed at internalizing the review process, if efficient. By analyzing said system with operational research, this paper concludes suggesting the potentiality of a competitive system of reviewers, that is to say, the efficiency of that internalization process is performed by medical centers in which the experimental treatments are proposed to subjects

Performance of the health care industry: the Italian case study

WP 16/2012; Considering the Italian healthcare system, the present study analyzes the aspects that might affect the efficiency of Italian hospitals. In this work, the authors analyze what influences a specific definition of efficiency, which is calculated maximizing healthcare production but minimizing potential financial losses. In other words, this work considers efficient each hospital which is able to maximize the production of medical treatments while complying, at the same time, with budget constraints. Hence, the results of this paper are two-fold: from the organizational point of view and from the technical one

Anti-dementia drugs. A descriptive study of the prescription pattern in Italy

Introduction: Acetylcholinesterase inhibitors (AChEIs) and memantine are currently the only anti-dementia drugs (ADDs) approved for treating Alzheimer's disease (AD) in Italy. This nationwide study aims to characterize dementia drug utilization in a population > 65 years, during 2018-2020. Methods: Different administrative healthcare databases were queried to collect both aggregate and individual data. Results: ADD consumption remained stable throughout the study period (~ 9 DDD/1000 inhabitants per day). AChEI consumption was over 5 DDD/1000 inhabitants per day. Memantine consumption was nearly 4 DDD/1000 inhabitants per day, representing 40% of ADD consumption. The prevalence of use of memantine represented nearly half of ADD consumption, substantially unchanged over the 3 years. Comparing the AD prevalence with the prevalence of ADDs use, the gap becomes wider as age increases. In 2019, the proportion of private purchases of ADDs was 38%, mostly represented by donepezil and rivastigmine. In 2020, memantine was the only ADD with an increase in consumption (Δ% 19-20, 1.3%). Discussion: To our knowledge, this study represents the first attempt to investigate the ADD prescription pattern in Italy with a Public Health approach. In 2019, the proportion of ADD private purchases point out several issues concerning the reimbursability of ADDs. From a regulatory perspective, ADDs can be reimbursed by the National Health System only to patients diagnosed with AD; therefore, the off-label use of ADDs in patients with mild cognitive impairment may partially explain this phenomenon. The study extends knowledge on the use of ADDs, providing comparisons with studies from other countries that investigate the prescription pattern of ADDs

Artificial Neural Networks and risk stratification in Emergency department

WP 12/14; The primary goal of the Emergency Department physician is to discriminate individuals at low risk, who can be safely discharged, from patients at high risk, who deserve prompt hospitalization for monitoring and/or appropriate treatment. Obviously, the problem of a correct classification of patients, and the successive hospital admission, is not only a clinical issue but also a management one since ameliorating the rate of admission of patients in the emergency departments could dramatically reduce costs and create a better health resource use. Considering patients at the emergency departments after an event of syncope, this work propose a comparative analysis between multivariate logistic regression model and Artificial Neural Networks (ANNs), highlighting the difference in correct classification of severe outcome at 10 days and 1 year. According to results, ANNs can be very effective in classifying the risk of severe outcomes and it might be adopted to support the physician decision making process reducing, at least theoretically, the inappropriate admission of patients after syncope even