More than 80% of drugs for all indications entering clinical development do not get marketing approval, with many failing late in development often in Phase III trials, because of unexpected safety issues or difficulty determining efficacy, including confounded outcomes. Many factors may be involved in this low success rate: among the others, the limited knowledge of the determinants of drug sensitivity and resistance; heterogeneous patient populations and lack of biomarkers to identify patients most likely to benefit from specific treatments; the design of the clinical trials, which are often made on the basis of the "traditional statistical"
Areas Covered in the Session:
We will begin by reviewing the traditional statistical design of clinical trials in Oncology
We will look over the introduction of targeted therapies in the Oncology field and the related different needs . Examples will be provided about the most important types of tumors , as well as the more rare diseases.
We will also review the requirements of the regulatory authorities (FDA, EMEA).
Finally, an analysis of the new endpoints related to the different mechanism of action of the new therapies will be provided.
Who Will Benefit:
Companies involved in the development of new anti-cancer drugs
Professionals involved in the design of clinical trials in Oncology
Rossana Berardi, MD is a Consultant Medical Oncologist and Lecturer at University Hospital. She is also the Responsible of the Trial Unit at Dept of Oncology – Università Politecnicadelle Marche – Italy. Dr Berardi usually deals with about 35 GCP trials/year with new drugs, with a special focus on early phase trials.
Dr Berardi is Assistant Professor in Medical Oncology and in Semiotics at Università Politecnica Marche in Ancona and at the Doctorate in Osteoncology, Università "Campus Bio-Medico" in Rome. She is Member and national representative of the Lecturers in Medical Oncology of the Academic Medical Oncology Committee, Member of the “Post-Lauream Education” Working Group of the Italian Association of Medical Oncology and Member of the “Core Curriculum” task force of the European Society of Medical Oncology.
Dr. Berardi has been awarded many grants and prizes. She has authored many scientific publications and several presentations at national and international meetings. Dr.Berardi was a Research Fellow in the Department of Oncology at Middlesex Hospital, University College London Hospitals. Dr Berardi has a special interest in consulting with pharmaceutical companies regarding acquisitions and design of clinical trials. Dr Berardi has been selected as an expert evaluator in several boards of examiners (i.e. European Community).