PhD in Applied Clinical Research

The PhD programme in Applied Clinical Research is targeted at graduates with a degree in medicine interested in acquiring knowledge and developing skills in the field of clinical research.

The PhD programme will equip students with general, transversal and specific competencies, and train professionals who are able to design, conduct and critically evaluate independent and for-profit clinical research projects.

This PhD course aims to train “generators” of high quality, innovative clinical trials, able to take into account the economic sustainability and ethical aspects of research as well as the real applicability of the results as a means to improving the health conditions and quality of life of patients.

The involvement of cross-disciplinary expertise (medical, methodological, economic, ethical), and experts from different backgrounds (clinical-preclinical, industrial, economic, regulatory/decisional), underscores the interdisciplinary aspect that will characterize the doctoral programme in Clinical Research at Humanitas University.

Specifically, the doctoral student will:

• acquire the necessary tools for the identification and critical review of available evidence
• understand the regulation of clinical research
• acquire the tools to identify the correct type of study to be carried out according to the objectives and strengths/weaknesses of different types of clinical trials
• understand epidemiology and statistics for proper clinical study design
• understand economic principles underlying the economic sustainability of a clinical trial
• understand the basis of open science

At the end of the course, the doctoral students will have:

• learned the correct research methodology to be used for the specific objective: retrospective, observational or interventional, cross-sectional, prospective (from phase 1, including first-in-human studies, to phase 4 post-marketing) RTCs
• mastered the principles underlying the design, execution, and management of profit and nonprofit clinical research
• mastered the biostatistical foundations required for clinical trial design
• mastered the biostatistical foundations required for data analysis and proper interpretation of a clinical trial
• learned the economic foundations required for determining the sustainability of profit and nonprofit clinical research
• learned the regulatory and ethical principles of clinical research
• learned the principles of team working
• learned the basic principles of competitive grant writing
• mastered the basic principles of writing and submitting abstracts as well as manuscripts
• mastered the most effective ways of presenting clinical research findings to a lay audience (stakeholders)
• designed and conducted a clinical research project
• designed, written and submitted a research project to a national or international competitive call
• learned the basics in the area of open science

Career Opportunities

The expected employment outlets are managerial or high-profile careers in academia in biomedical disciplines and within public and private research organizations, public health, and the pharmaceutical or biomedical industry.

Specifically, the main areas of employment include:

• clinical research facilities (IRCCS, university hospitals);
• public and private research institutions operating in the biomedical field;
• ASLs and hospital companies, in areas dedicated to health monitoring and planning;
• Pharmaceutical companies (Clinical Development; Medical Affair Branch; Clinical Scientist; Manager Regulatory Operations) and Biotech pharmaceuticals;
• Clinical trial ethics committees.