Adaptive Design and Flexible Approval of Clinical Trials

Dose-finding clinical trials are among the most critical cornerstones of the healthcare system. In this broad research area, there are many decision making problems that are extremely challenging to address. However, a small improvement may result in significant benefits to the society. Dose-finding clinical trials are extremely expensive and require multiple time-consuming and complicated R&D phases. Despite all the costs and the long time these trials need to conclude (on average over ten years for each new drug/technology), only less than 15\% of these trials successfully end up in a new approved drug entering the market. This problem is even exacerbated for the drugs that target rare diseases, where the costs of testing subjects are higher, sampling budgets are more restricted by the number of available patients, and the chances of success and expected payoffs are at much lower levels. In this dissertation, we first propose a new information-based objective function to guide the adaptive dose allocation as a part of Phase II clinical studies for which we show its merit in small sampling budgets. Then, we redesign Phase II clinical trials with the goal of personalizing this process and to find different target doses with certain efficacy levels, for different groups of patients. Finally, we move on to the FDA aspect of the approval process, and analyze flexible approval policies that the FDA can apply to Phase III clinical trials. The motivation for this work is based on recent studies that suggest flexible approval process can incentivize the research and development of new drugs for rare diseases. We hope that the results of our research help the clinicians, pharmaceutical companies, and the FDA with better understanding the consequences of their decisions, while leading to potentially more effective treatment/dose specification for the patients who are in need of new drugs

Fund Jurisdiction Over Capital Movements Comments, Panel On Preventing Asian Type Crises: Who If Anyone Should Have Jurisdiction Over capital Movement?

Within the last two years, the Fund has given extensive consideration to the questions of whether the liberalization of capital movements should be pursued through an amendment of its Articles of Agreemen

Create value at the University: Financial and management problems in USOs

The aim of this work is to analyze the phenomenon of university spin-off (USOs). The importance of this chance as a vehicle for the realization of university research results is underlined by the development that this kind of company have had in Italy in recent years. The study is led both through literature and the analysis of a case. The reported experience is the one of the USOs of Tuscia and allows to highlight how the beginning of a USOs is a complex process that often must overcome many obstacles as in management, in corporate governance and above all in financial, because of the difficulty in finding economical resources. That’s why, the use of normal instruments of management control can make easier the start-up of these companies contributing to the creation of a clear organizational structure. It also assumes the possibility of further development of these companies, thanks to their innovative and high technology and to investment founds through venture capital operations, especially in the start-up phase of the company