Clinical studies (also known as trials) are research studies that evaluate the effectiveness and safety of new treatments, with the goal of preventing, diagnosing, or treating cancer, or improving existing treatments.
: FREQUENTLY ASKED QUESTIONS
What Is a Clinical Trial?
A clinical trial involves patients with the goal of finding new ways to prevent, diagnose, or treat a disease, or to improve existing treatments.
The programs are divided into:
- Observational studies: in which doctors collect information about participants’ health without changing the care they receive.
- Interventional (or experimental): in which a treatment or intervention is tested, such as a new drug, a combination of drugs, or a new therapeutic technique.
Some studies may be randomized: this means that participants are assigned at random (similar to a lottery) to different treatment groups. This allows for an unbiased comparison of the effectiveness of treatments.
Why are clinical trials important?
Clinical trials are essential for advancing research and providing increasingly effective and safe treatments.
Thanks to them, many of the cancer treatments used today have been discovered and improved.
Participating in a clinical trial means contributing to the development of new treatment options—for yourself and for future patients. In addition, in some cases, it provides access to innovative and promising therapies before they become widely available.
What are the phases of a clinical trial?
The “phases” of a clinical trial primarily refer to studies that evaluate new drugs or new treatments. Each phase is designed to gather different types of information, always with the goal of ensuring safety and efficacy for patients.
- Phase I: evaluates the safety, dosage, and initial efficacy of a new drug in a small number of people;
- Phase II: evaluates the treatment’s efficacy and further assesses its safety;
- Phase III: Compare the new treatment with the standard treatment in a larger group of patients;
- Phase IV: Studies conducted after a drug’s approval to monitor its safety and efficacy in real-world clinical practice, identify rare side effects, and optimize its use in patients.
Not all clinical trials, however, are divided into phases: some observational or non-pharmacological studies follow different research methodologies.
Who can participate in a clinical trial?
If the doctor believes a study may be appropriate, they will provide all the necessary information and invite the patient to an informational meeting.
Before beginning, an Informed Consent form is signed—a document that clearly explains the study’s objectives, procedures, benefits, and possible risks.
Participation is always voluntary, and the patient may withdraw at any time.
Are there any risks involved in participating?
As with any treatment, clinical trials may also involve risks or side effects.
All trials are approved by ethics committees and monitored by specialized medical teams to ensure the highest possible level of safety.
Before enrolling, the potential risks and available alternatives are clearly explained.
What are the benefits for participants?
Participants can access innovative treatments before they are available to everyone , while receiving careful and frequent medical monitoring.
Furthermore, they contribute directly to the progress of research and the development of new therapies for the future.
Can I continue my treatment with my oncologist?
Yes. If you participate in a clinical trial, your oncologist will continue to monitor you and manage your treatment.
The study team works in collaboration with your doctor to ensure continuity, safety, and support throughout your participation.
How can I find out if there is a clinical trial that’s right for me?
The first step is to talk to your oncologist, who can check whether there are any ongoing clinical trials that match your clinical situation.
You can also review the information available on the Institute’s website or contact the clinical research staff for assistance. We’d be happy to work with you to evaluate the most suitable options.
What does it mean when a study is “active” or “in the process of being activated”?
- Active trial: The trial is open, and the clinical center is already evaluating new patients for participation. If you think you might be interested, you can discuss it with your doctor or contact the center conducting the trial.
- Clinic in the process of opening: The clinic is not yet open to patients because the organizational and authorization procedures required to launch it at the clinical center are still underway. This means it may become available in the coming weeks or months.
ABOUT US
The Clinical Research Unit (CRU) is the unit within the Clinical Research and Innovation Division that coordinates, in an integrated manner, all departments and services involved in clinical trials, both for-profit and nonprofit.
With organizational, management and regulatory expertise, the CRU ensures consistency, quality and continuity at every stage of trials, facilitating collaboration among researchers, sponsors and patients.
The Unit operates in accordance with standard operating procedures (SOPs) that are constantly updated in line with Good Clinical Practice (GCP) and Italian and international regulations, promoting efficiency, transparency, and collaboration among researchers, patients, and sponsors.
The CRU’s activities are organized into ten main areas, which include: quality, regulatory affairs, study management, pharmacovigilance, Phase 1 studies, compassionate use, studies sponsored by the Institute, administrative management, and staff training.
Director of Clinical Research and Innovation

For more information or to find out if you are eligible to participate in a study, please email: ufficio.trials@inoc.it
To initiate new clinical trials, please email: clinicalstudy.startup@inoc.it