Clinical Trial
Isola Tiberina – Gemelli Isola Hospital has among its main objectives to promote research for the benefit of patients.
The ultimate goal is to offer the best possible treatment options by accessing the most up-to-date healthcare innovations to improve care, diagnosis, and quality of care. Therefore, the Clinical Research Center (CRC) has been established since October 2022.
This Center is to support all personnel who are or would like to be involved in Research in order to properly manage and conduct both Profit and Non-Profit studies (Clinical Trials with drug, with devices and/or Observational Studies) in accordance with all applicable Regulations.
Clinical-Scientific Area Director: Prof. Sergio Alfieri
Head of Clinical Research Center: Dr. Vincenzina Mora
If you intend to submit a study, contact:
Technical-Scientific Secretariat: Elisabetta Berrettoni
tel. 0668370502
email: elisabetta.berrettoni@fbf-isola.it
and view the Lazio 3 Ethics Committee website
Understanding clinical trials
A clinical trial is any human study designed to discover or verify the effects of a new drug or an existing drug tested for new therapeutic uses, with the aim of ascertaining its safety or efficacy.
Data collected from a clinical trial are analyzed by the Italian Drug Agency (AIFA) or the U.S. Food and Drug Administration (FDA), which decide whether or not to approve the drug.
Participation in a clinical trial is voluntary. The greater the number of participants, the more information there will be about the drug and thus it will be easier and more effective to develop new therapies by improving the treatment offerings for patients. The results of these studies can help researchers find new ways to prevent, diagnose and treat various diseases.
Before agreeing to participate in a clinical trial, it is important to know that there are also risks, but the study investigator will be able to help you understand them. However, because the drug is experimental, efficacy is not yet proven, and before starting a clinical trial, not all the risks are known, so you may experience side effects during treatment.
Information about trials is available from the Hospital’s Clinical Research Office and at: 0668370502
Clinical trials are conducted by a team that includes:
- A principal investigator, a physician who leads the research team
- A research team, which may include physicians, nurses, study coordinators, and other health care professionals
- Participants, who are the people who agree to take part in the study
The research team follows a “protocol” that gives instructions on how to conduct the study. The protocol includes information on:
- Why the study is being conducted
- Who the study is for
- What drug or treatment will be used
- How long the study will last
- What tests will be performed on the participants
The location of the clinical trial depends on who is conducting the study. It can be in several locations, including:
- A hospital
- A clinic
- A university
- A medical office
Developing a new drug takes a long time, as there are several steps before it is marketed, so a trial can usually last up to 10 years.
The first step includes a preclinical trial, which includes study of the scientific literature and laboratory experiments with the drug.
Drugs that appear to be better move on to the next step of clinical trials. There are four phases of a clinical trial. Each stage has a different purpose and helps the researcher answer specific questions.
- Phase 1 usually tests the safety of a drug or treatment. It helps researchers know what dose of medicine people can safely take. Any side effects are also checked. This phase includes 20-90 people.
- Phase 2 is used to test effectiveness, that is, whether the drug or treatment works in people with the condition to be treated, for which the drug or treatment was designed. It goes on to test safety in a larger group, usually between 100-300 people.
- Phase 3 makes sure that the drug or treatment works. You continue to check for side effects. You also test how well it works compared to other treatments. This phase includes a larger group of people, usually between 1,000-3,000 participants. After Phase 3, all information is shared with AIFA or FDA who decide whether the drugs can be approved.
- Phase 4 examines the drug or treatment after it has been approved. Researchers continue to monitor its safety. New information can also be obtained about how it works and the best way to optimize its use.
Common reasons why people decide to participate in a clinical trial include:
- Gaining access to experimental drugs not yet approved by AIFA or FDA
- Taking an active role in their own health
- Helping researchers study and understand so they can develop better drugs so they can treat all those patients who do not yet have an adequate therapy
Whatever the reason, there are many things to think about before making a decision. Information on trials is available from the Hospital’s Clinical Research Office and at: 0668370502
Every clinical trial has guidelines. These guidelines help physicians decide who should or should not participate in the study. Guidelines in studies may include:
- Age
- Gender
- The type or stage of a disease
- Treatment history
- Other medical conditions
The reasons that allow people to participate in the study are called inclusion criteria. The reasons that prevent people from participating in the study are called exclusion criteria. Informed consent: People interested in a clinical trial have an interview with the physician overseeing the study. Doctors and nurses on the team explain the details of the study using the informed consent form and help people understand the potential risks and benefits of the study and then decide whether they can and want to participate in the study or not. Those who want to participate in the study will be asked to sign an informed consent document. This document explains:
- The purpose of the study
- How long the study will last
- How the study will be performed
- Key contacts in the study
- Risks and potential benefits
Signing this document does not mean you have to stay in the clinical trial. You can leave the study at any time.
If you decide to participate in a clinical trial, you will probably have questions. Some of your questions may be answered in the informed consent document. However, you will be able to ask the research team as many questions as you need to get a better understanding of the study. It is important to have all the answers before you decide to take on the clinical trial. Not sure what to ask? Here are some food for thought:
- Why are they doing this clinical trial?
- What types of tests and treatments will be involved?
- How long will the study last?
- How might this study affect my daily life?
- Where will I have to go to participate in the study?
It is important to understand that possible risks could include:
- Side effects that can range from unpleasant to more serious
- The treatment does not work or help you get better
Possible benefits of participating in a clinical trial include:
- Taking an active role in your own health
- Gaining access to an experimental treatment
- Helping others
Participant safety
Safety is very important in a clinical trial. The researchers leading a study will closely monitor the progress. They will assess any impacts that may not be safe for you. Clinical research also follows safety rules set by AIFA or FDA. These rules are built in to protect people in the study. Results are shared with AIFA or FDA and medical journals as the study goes on so that everyone can see the results. You should always feel comfortable talking to the study team if you feel unsafe.
