Books

Lorenzo Pradelli, Albert Wertheimer

Resource constraints in healthcare and the rising costs of new treatments have prompted the use of pharmacoeconomic studies. New techniques make it possible to adapt to the specificity of each situation, thus returning accurate calculations and estimates.
The desire to publish a more up-to-date version of ‘Pharmacoeconomics. Principle and Practice’ fits into this context and provides readers with the basic principles of this complex discipline. Compared to the version published 10 years ago, new techniques have been described, a whole new chapter on epidemiology has been added, and the reference literature and examples have been updated…

Giovanni Tripepi

This guide has been written with the aim of facilitating, in a simple and intuitive way and starting from the research question, the understanding of the most important concepts of biostatistics and clinical epidemiology related to observational studies. Furthermore, through a series of practical examples focused on “how to do it”, this pocket guide is intended to be a quick and easy reference tool to guide the clinician and biologist in the analysis, presentation and interpretation of results in the context of aetiological, diagnostic and prognostic observational studies….

Razionale, criticità e applicazioni nel contesto italiano

Real World Evidence’ refers to clinical evidence on the use and possible effects of a therapy as derived from the analysis of data from clinical practice (so-called ‘Real World Data’). In recent years, Real World Evidence data have been increasingly used by different stakeholders: by pharmaceutical companies for research & development, by the medical community for clinical practice analysis, by regulatory agencies to monitor post-marketing safety…

Güvenç Koçkaya, Albert Wertheimer

Market access is the process by which a pharmaceutical company gets its product available on the market after having obtained a marketing authorization from a regulatory agency and by which the product becomes available for all patients for whom it is indicated as per its marketing authorization.
It covers a group of activities intended to provide access to the appropriate medicine for the appropriate group of patients at the appropriate price (in most countries)…

Güvenç Koçkaya, Albert Wertheimer

The definition of market access was first reported by the World Trade Organisation as “opening markets to trade and improving transparency, reciprocity and non-discrimination in international trade”. Pharmaceutical market access is different and could be defined as achieving the optimal price for a product or service and/or maximum reimbursement for the approved target population, without restrictions on funding for medical technology…

An Overview

The aim of this book is to provide a general overview of the process of translation and cultural adaptation of survey instruments for clinical research, with a focus on the linguistic aspects of the process. Survey instruments are defined as any text, printed or electronic, prepared to collect information in a clinical research context. This broad definition includes outcome measures reported by the patient, physician and caregiver, as well as patient diaries, indices, scales, symptom checklists, etc. …

An Overview

Patient-reported outcomes (PRO) are a measurement based on an account that comes directly from the patient about the state of health, without modification or interpretation of the patient’s response by a physician or anyone else.
Valid and reliable PRO instruments are able to provide a standardised and quantifiable measure of treatment benefit, on the basis of which the results of interventions and the effect of treatment can be judged from the patient’s point of view…

Giuseppe La Torre

In the era of evidence-based medicine, health professionals must fully understand the design, analysis and interpretation of research results. Furthermore, they must be able to assess the needs of their communities and respond accordingly. To achieve these goals, physicians must be familiar with the basic concepts of epidemiology and biostatistics. But epidemiology is more than ‘the study of’. Its application and practice are essential to address public health problems…