AIMS AND LEARNING OUTCOMES

After a brief introduction to the concept of management in health care and the importance of quality in clinical research, the course will focus on detailing the different aspects involved in observational and experimental clinical trials by providing all the useful tools for properly designing a clinical trial.

THE TRAINING OBJECTIVES IN DETAIL ARE:
- Describe the role of management in healthcare and illustrate through real examples the concepts of SWOT analysis, Logical Framework Approach and Gantt chart representation.
- Correctly select quality tools and indicators in predefined healthcare settings.
- Detail the different levels of scientific evidence, from case series to systematic reviews.
- Identify and discuss the main differences between observational and interventional studies.
- Develop skills in designing and conducting a clinical trial.
- Draft a case report form, a protocol and other key documents needed to conduct a clinical trial.
- Know how to read, interpret and write a scientific paper.

LEARNING OUTCOMES.
At the end of the course, the student will acquire adequate knowledge and understanding of various aspects around the concept of quality in health care, especially in the context of clinical research. He/she will be able to actively participate in the development and implementation of research projects, identifying and using the main tools and methods necessary to design and manage a clinical trial, and, where applicable, making use of standardized procedures.

Specifically, depending on the context, resources, and objective, he/she will know how to correctly choose the study design, identify the sample, treatment, and duration of the study.

Finally, he or she will be able to critically read the results reported in a scientific publication and write a manuscript reporting the evidence from the research he or she conducted.
The skills acquired during the course will be a useful background for those who will go on to work in public administration to support the planning and implementation of projects in health care. Moreover, in recent years, the prospects and opportunities for clinical research work in the private sector are growing exponentially: therefore, this knowledge is a valuable basis for securing a position in pharmaceutical industries and CROs (Contract Research Organizations).

TEACHING METHODS

Unless otherwise directed by the University in the area of health security, the teaching will be delivered in a blended mode, balancing face-to-face, group work, and other interactive teaching activities (debate on course topics, simulation of preparing and conducting a clinical study), according to the schedule provided by the Graduate Program.

Students must ensure attendance to at least 75 percent of the lectures; in fact, classroom participation is a key moment in the process of discussion and learning.

SYLLABUS/CONTENT

Introduction to the course

Management in health care

From idea to project: concept phase, planning phase, implementation phase, closing and evaluation

Context assessment: the SWOT analysis

The Logical Framework Approach

Action plan: what is a Gantt chart? 

Quality management in health care: tools and indicators

Quality clinical research

Hierarchizing scientific sources: the pyramid of evidence

Tools and guidelines for operating in quality

From research question to study design 

Time to ask some questions: why? Who? How many? For how long?

The sample, the right sample

Treatment management

Pharmacovigilance in pills

Observational studies

A brief roundup of observational studies

Bias and confounding

Limitations and strengths of an observational study

Ethics and regulations

Experimental studies

Identifying the scientific rationale

Setting the stage: scientific evidence and disease history

The sample to be enrolled: Biostatistical SOS

• Enrollment criteria
• Sample size
• Defining study populations
• Selecting subgroups
• Someone always gets lost along the way... "lost to follow up"

Appropriate experimental design

Endpoints (primary, secondary, and composite) and outcome measures

Randomization: is it just a matter of chance?

Masking: the not knowing in favor of scientific rigor

Placebo

• Singing the placebo: a history thousands of years long
• Is it unethical to use it or unethical not to use it? 
• Much ado about nothing? 
• What guarantees the curative effect of placebo

Clinical trials: a long journey

Person involved in clinical research: a shared responsibility

Before beginning: Declaration of Helsinki & GCP

Step-by-step from research question to scientific paper

Scripta manent: drafting key documents

Is everything possible? Feasibility analysis.

Funding is needed: the role of Sponsors

Submission of documentation to Competent Authorities 

Execution of the research

The right data in the right place: the CRF

Software for managing a study

Data management: data congruence and consistency

Data speak: what do they tell us?

CSR: Clinical Study Report... or rather, We succeeded!

Sharing results with the working group.

So much effort to...?...Public or perish

Ethical and editorial aspects of a publication

Where to publish?

Drafting the manuscript 

Submitting, waiting, revising and ... crossing fingers!

"Quality" of the manuscript and "quality" of the researcher: bibliometric indicators

 The tools for reading and interpreting the results of a clinical trial

RECOMMENDED READING/BIBLIOGRAPHY

Teaching materials will be prepared by the professor and shared on web classroom.