PhD in Applied Clinical Research

The Programme

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.

Didactic Activities

The PhD programme includes the writing of a clinical research protocol as a thesis project under the supervision of a tutor and faculty members of the doctoral program. The thesis project is a structured activity involving the design and implementation of a research project aimed at the practical application of the knowledge acquired.

The PhD student is expected to:

• participate in clinical research activities under the supervision of the mentor
• write a proposal for national and international competitive grant
• design a clinical study
• write at least 1 clinical paper as first author

Admission Requirements

Applicants wishing to apply for the PhD course in clinical research must have:

• an Italian degree in Medicine and Surgery or equivalent qualification awarded by a foreign university
• the license to practice as a doctor
• the registration to the professional order of physicians
• a medical residency programme (concluded on ongoing)

Applicants who have not yet graduated at the date of application may still take part in the selection process providing they have passed all of their degree programme exams at the time of the online application, and will have been awarded the qualification before the beginning of the academic activities. Should these applicants pass the selection process, their enrolment on the PhD course is conditional upon providing proof that the qualification has been awarded.

How to Apply

• Registration or access with your LOGINMIUR credentials
• Submission of the application form. On penalty of exclusion, the application form must be fully completed in all its parts, as indicated in the Call for Applications.
• Payment of the application fee

Admission Process

Admission to the PhD Programme is based on a public selection process consisting of:

• the comparative evaluation of titles and qualifications
• an interview carried out in English by an appointed Committee

The aim of the selection process is to assess the knowledge, competencies and aptitude of the applicants for clinical research as well as their motivation for undertaking the PhD programme.

A good knowledge of English is required and will be tested during the interview.

Academic Board

PhD coordinator: Professor Andrea Lania

Research Topics