Biography:
Giuseppe Assogna born in the Metropolitan city Rome, Italy. He studied a degree in medicine and Surgery cum Laude at University La Sapienza, Rome (Italy). He obtained qualification for medical profession at University of Rome. He obtained Specialization in Liver Diseases at University of Rome. He was worked as Contract Professor from 1990-1992at the University of Naples (Italy), School of Specialisation in Pharmacology and Clinical Pharmacology. He was worked as Contract Professor from 1990-1992at the University of Naples (Italy), School of Specialisation in Pharmacology and Clinical Pharmacology. He was also worked as Contract Professor from 2003- 2004 at the University of Pavia, School of Specialisation in Regulatory Disciplines. He currently works as a Senior Consultant at SIC (Italian Society of Cardiology), President at SIFEIT (Italian Society for Studies in Economics and Ethics on Drug and Therapeutic Interventions), Senior Pharma and Management consultant (Clinical Research, Medical Affairs, Regulatory, Market Access, Start-up foreign companies, Compliance and Governance, Crisis Management). He is a member of the SSFA (Italian Society of Applied Pharmacological Science), SIFEIT (Italian Society for the study of drug Economics and Ethics and Therapeutic Intervention), AILAS (Italian Society for avoiding Stigma), SITAC (Italian Society for Treating Alcohol Consumption) and Former active member of SIDR (Italian Society of Reproduction), ESHRE (European Society of Human Reproduction.
Abstract:
Clinical trials are research studies involving patients in order to evaluate how different treatments are safe and work. Similarly clinical trials are carried out to try to answer specific questions on health and illness and are the best way to compare different approaches to preventing and treating illness and health problems.
Clinical trial methodology as well as rules governing this important area of research, are actually regulated, in EU countries, by the Directive 2001/20/EC, to be replaced by the clinical trials - Regulation EU No 536/214, which will come into force, most likely, in October 2019.
The new regulation has many positive aspects, such as authorization timing, monitoring for all studies (profit and no profit), transparency of results, etc., while some aspects may raise criticalities, like low intervention clinical trials and insurance indeminities.
As for budget impact of clinical trials, according to a 2014 study by the Tufts Center for the Study of Drug Development (TCSDD), the cost of developing a new drug, from research and development (R&D) to marketing approval, is approximately $2.9 billion and althoug clinical trials evaluate pharmacotherapeutic intervention under highly controlled conditions, remainds a need to evaluate medication use in real clinical practice.
In this high cost scenario is there a concrete possibility to try to reduce (part of) the cost of drug development? Probably yes, according to the Avicenna - A Strategy for in Silico Clinical Trial – document, published in 2015.
The document focuses on “how biomedical products are developed today, where in silico clinical trials technologies are already used, and where else they could be used. From the identification of the barriers that prevent wider adoption, we derived a detailed list of research and technological challenges that require pre-competitive funding to be overcome”.