PhD in Applied Clinical Research
The PhD in Applied Clinical Research will provide the basic principles of clinical and applied research with the direct involvement of research institutions, public and private research hospitals, regulatory bodies, pharmaceutical companies and stakeholders.
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
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.
|PhD Coordinator: Prof. Andrea Lania|
The number of available places and/or scholarships may increase in the event that external funding becomes available by the deadline set for the completion of the call application procedure.
|Beginning of the academic year
1st December 2023
11th July 2023
|Regolamento PhD Applied Clinical Research|
|For further information you can contact firstname.lastname@example.org|
|Module 1: Epidemiology and Biostatistics|
|Module 2: Research Ethics|
|Module 3: Advanced Statistics|
|Module 4: Principles and Practice of Clinical Studies|
|Module 5: Conducting a clinical trial|
|Module 6: Interpretation and dissemination of results|
|Module 7: Translational and correlational studies applied to phase 1-2 clinical trials|
|Module 8: Digital Medicine and Clinical Studies|
|Module 9: Regulatory Aspects|
|Module 10: Participation in Competitive Grants
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
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 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.
PhD coordinator: Professor Andrea Lania
|Name||Principal Affiliation||Department||Job Title||Academic Recruitment Field||CUN Area||Academic Discipline|
|ALIBERTI Stefano||HUMANITAS University||Biomedical Science||Full Professor||06/D1||06||MED/10|
|ARMUZZI Alessandro||HUMANITAS University||Biomedical Science||Full Professor||06/D4||06||MED/12|
|AZZOLINI Elena||HUMANITAS University||Biomedical Science||Associate Professor||06/M1||06||MED/42|
|BARTOLETTI Michele||HUMANITAS University||Biomedical Science||Associate Professor||06/D4||06||MED/17|
|CARLO STELLA Carmelo||HUMANITAS University||Biomedical Science||Full Professor||06/D3||06||MED/15|
|CENTO Valeria||HUMANITAS University||Biomedical Science||Associate Professor||00||06||MED/07|
|D’INCALCI Maurizio||HUMANITAS University||Biomedical Science||Full Professor n.t.||05/G1||05||BIO/14|
|DE SANTIS Maria||HUMANITAS University||Biomedical Science||Assistant Professor||06/D3||06||MED/16|
|DI SIMONE Nicoletta||HUMANITAS University||Biomedical Science||Full Professor||06/H1||06||MED/40|
|HASSAN Cesare||HUMANITAS University||Biomedical Science||Associate Professor||06/D4||06||MED/12|
|LANIA Andrea Gerardo Antonio||HUMANITAS University||Biomedical Science||Full Professor||06/D2||06||MED/13|
|LAZZERI Massimo||HUMANITAS Research Hospital||Biomedical Science|
|LOPPINI Mattia||HUMANITAS University||Biomedical Science||Assistant Professor||06/F4||06||MED/33|
|MAZZIOTTI Gherardo||HUMANITAS University||Biomedical Science||Associate Professor||06/D2||06||MED/13|
|RIMASSA Lorenza||HUMANITAS University||Biomedical Science||Associate Professor||06/D3||06||MED/06|
|SCORSETTI Marta||HUMANITAS University||Biomedical Science||Full Professor||06/I1||06||MED/36|
|UCCELLA Silvia||HUMANITAS University||Biomedical Science||Associate Professor||06/A4||06||MED/08|
|ZAMBELLI Alberto||HUMANITAS University||Biomedical Science||Associate Professor||06/D3||06||MED/06|
|ZERBI Alessandro||HUMANITAS University||Biomedical Science||Full Professor||06/C1||06||MED/18|
|ZUCALI Paolo Andrea||HUMANITAS University||Biomedical Science||Associate Professor||06/D3||06||MED/06|
|Topic ID||Supervisor||Project title|
|CLI 2||Spinelli||Immersive reality for robotic surgical training|
|CLI 4||Lazzeri||Single cell dissection of the tumor microenvironment in patient with urothelial bladder cancer for the identification of predictive tools and new therapies|
|CLI 5||Francone||Advanced Computed Tomography technology for novel targeted atherosclerosis therapy|
|CLI 6||Di Simone||“NutriPregLoss” study: Impact of nutrition on recurrent pregnancy loss.|
|CLI 8||Selmi||Applications of Artificial Intelligence for innovative, personalized, and multidisciplinary approaches to early diagnosis and clinical management of patients suffering from immune-rheumatologic diseases.|
|CLI 10||Hassan||AI-Enhanced Intervention to Reduce Emergency Department Revisits within 9 Days of Discharge.|
|CLI 13||Condorelli||Inflammatory predictors of progression to end-stage heart failure|
|CLI 15||Torzilli||Investigating mechanism of liver regeneration after scaffold sparing hepatectomy and major hepatectomies by means of vessel amputation|
|CLI 18||Repici||Evaluation of non-invasive biomarkers for the diagnosis and the monitoring of eosinophilic esophagitis|
|CLI 19||Santoro||“Advanced diagnostic characterization through comprehensive molecular profiling to tailor appropriate treatments such as antibody-drug conjugates (ADCs), bispecific antibodies and new targeted therapies in metastatic breast cancer”|
|CLI 20||Castagna||Evolution of the design of shoulder prosthesis stem and glenoid: clinical and radiological outcomes|
|CLI 21||Loppini||Development and validation of 3D printed models for preoperative planning and intraoperative guide in joint replacement revision surgery.|
|CLI 23||Kon||Development and validation of an animal model of degenerative meniscus and identification of parameters related to different levels of risk of progression of post-meniscectomy knee osteoarthritis|
|CLI 25||Carlo-Stella||Use of Loncastuximab Tesirine in patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBCL) who have progressive disease after CAR T-cell treatment|
|CLI 26||Costanzo||Personalization of therapies for inflammatory cutaneous diseases: a patient-centred analysis of clinical trials and real-world registries with a focus on comorbidities|
|CLI 27||Aliberti||Identifying clinical phenotypes and endotypes in bronchiectasis patients|
|CLI 28||Mazziotti||EFFECTS OF BISPHOSPONATES AND DENOSUMAB ON VASCULAR END-POINTS AND THEIR CORRELATION WITH SKELETAL HEALTH IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS: THE TWO FACES PROJECT.|
|CLI 30||Furlan||PATIENT SAFETY: MANAGEMENT AND ERROR ANALYSIS THROUGH HIGH FIDELITY CLINICAL SIMULATION SCENARIOS.
Comparison of advanced methods with root cause analysis.
|CLI 31||Rimassa||Multicenter clinical and translational study of first-line treatment with cisplatin, gemcitabine, and immune checkpoint inhibitors for advanced biliary tract cancer|
|CLI 32||Tinterri||Sentinel lymph node biopsy only versus axillary lymph node dissection in breast cancer patients undergoing mastectomy with 1-2 metastatic sentinel lymph nodes: enrollment in single-arm prospective experimental clinical trial|
|CLI 33||Politi||Holistic assessment of AI softwares in theradiology value chain: understanding the value for the patient and for healthcare expenditure.|
|CLI 34||Hassan||Development and validation of artificial intelligence algorithms for screening and surveillance of oncological pathologies of digestive tract|