In recent years many introductory textbooks on clinical trial methodology have been published, some of which are excellent, in addition to a very extensive specialist literature. Nevertheless, here is a new book on methods and issues in clinical research. The objectives can be summarized in three points. 1. Integrate medical and statistical components of clinical research. 2. Do justice to the operational and practical requirements of clinical research. 3. Give space to the ethical implications of methodological issues in clinical research.

The scope of clinical research is to evaluate the effect of a treatment on the evolution of a disease in the human species. The treatment can be pharmacological, surgical, psychological/behavioral or organizational/logistic. The disease, intended as an impairment of a state of well-being or a condition capable of provoking such impairment over time, can be universally accepted as such (e.g. a cancer or a bone fracture) or perceived as such only by limited groups of individuals in a given cultural context (e.g. hair loss or weight gain). The course of the disease that ones wishes to change can be the one with no intervention or, more frequently, the one observed with the available treatment. The evaluation of the effect of a treatment on the course of a disease is a lengthy process, which progresses in increasingly complex stages.

A detailed coverage of the logistic, administrative and legal aspects of clinical research is outside the scope of this book. However, throughout the book we keep reminding the reader of these aspects because, as already mentioned, we firmly believe they have a crucial role in determining the success of a study. The history of clinical research is paved with relics of studies started with great pomp, riding great ideas and great hopes, which drowned miserably because of inadequate logistical preparation. In our experience, the excessive complexity of a clinical trial is the single most frequent cause of failure: the study is perfect on paper, but impossible to implement by patients and staff alike. The distance between the principal investigators and the reality of clinical research in its day-to-day practice is often the main cause of such disasters. We warmly encourage everyone involved in clinical research to get involved in the logistics of a study, learning from colleagues responsible for its practical conduct (clinical research associates, data managers, etc.) and to take part, in person, in the practical implementation of a trial before attempting to design a study protocol.

The book ends with a brief description of the drug development process and to the phases of clinical development.

Here is a new book on methods and issues in clinical research. Its objectives can be summarized in three points. 1. Integrate medical and statistical components of clinical research. 2. Do justice to the operational and practical requirements of clinical research. 3. Give space to the ethical implications of methodological issues in clinical research. The book ends with a brief description of the drug development process and the phases of clinical development.

Questo libro A] dedicato ai principi per la costruzione del piano di un singolo studio clinico e dell'intero programma di sviluppo clinico di un nuovo principio terapeutico. Gli autori, uno statistico e l'altro medico, hanno anni di esperienza nella pianificazione, conduzione, analisi ed interpretazione di studi sperimentali. Lavorando a quattro mani su ciascuno dei capitoli del libro, si sono posti come obiettivo principale quello di creare un linguaggio comune ed un "filo" logico rigoroso, ma consono ad entrambe le discipline. I principali temi della metodologia della ricerca sono affrontati con taglio applicativo e dovizia di esempi. Le fonti della variabilitA biologica e di misurazione, la scelta dei soggetti e dei trattamenti, le basi dell'inferenza e del test statistico, le ragioni della randomizzazione e del mascheramento dei trattamenti, le basi dei principali disegni sperimentali, le fasi della ricerca clinica, sono tra gli argomenti trattati nel testo. Per il suo taglio applicativo, ma non limitato ai principi piA elementari della ricerca sperimentale, puA essere utile ai ricercatori biomedici, cosA� come ai giovani statistici che si avviano alle discipline biomediche.