Why should I volunteer for a clinical research trial?

Only you can make a responsible and informed decision on whether participating in a clinical trial is good for you.

In making such a decision, you should always consider that participation in a clinical research trial gives you the possibility to:

- Play an active role in your own health care
- Gain access to advanced new treatments that are not yet available for the general public
- Gain access to complementary health exams or/and treatments
- Assist your family and/or others
- Make a significant contribution to the advancement of both basic and clinical research, as well as, health care

At the CRC we make sure your experience is comfortable and provide an enjoyable environment where you can study, read, relax, or watch TV and videos.

If you would like to know more about clinical trials, please read our clinical trial brochure Guide for Study Participants.

Guide for Study Participants

As you consider participating in a clinical trial you may have some questions.

What is a clinical trial?
A clinical trial is a research study employing human volunteers, and designed to therapeutically address specific health issues. Clinical trials measure the safety and effectiveness of drugs, devices and/or medical procedures in humans.

Who is eligible to a clinical trial?
All clinical trials have standard guidelines delineating who can participate to a research study. Before participating to a clinical trial, a participant must qualify for the study. Some clinical trials seek participants with specific illnesses or health conditions, while others only need healthy participants.

What are the advantages of participating in a clinical trial?
Participating to well-executed clinical trials will allow eligible participants to:

- Participate in cutting-edge research from top pharmaceutical industry and academic investigators.
- Gain access to new research treatments.
- Help to advance medical science.
- Obtain complementary medical exams and care during the trial.

Are there risks involved?
There are generally known and unknown risks associated with clinical trials. Some clinical trials can have unpleasant or even life-threatening side effects. Some side effects appear during treatment, while others may not show up until the study is completed. Side effects can be temporary and last only throughout the study, some can be permanent. Most of the risks depend on the treatment being studied as well as the overall baseline heath condition of the people involved. All risks are fully explained by the researcher before the trial begins and/or any time they arise during the study.

How are people protected?
Most clinical trials are regulated by government authorities, and designed with built-in safeguards to protect participants. To help protect the rights and welfare of volunteers and to verify the quality and integrity of data submitted for review, the Italian Ministry of Health performs regular “on site” inspection of clinical trial study sites and interviews on anyone involved in the research.

What is a protocol?
A “protocol study” is a study plan on which all clinical trials are based. The plan is designed to validate the effectiveness and safety of a molecular compound or a medical device on humans. The study protocol describes the time schedule of tests, procedures, drug dosage, as well as, inclusion/exclusioncriteria for volunteer enrolment.

What is an informed consent?
Regulations require that volunteers participating to a study are informed about key facts concerning the trial before one is asked to participate. To help volunteers in their decision, physicians and nurses illustrate to the volunteer all the details of the study, such as: purpose, duration, procedures, potential risks and benefits. The volunteer then decides whether or not to sign and participate to the study.

Can I change my mind?
When volunteers join a clinical study, he or she can leave the study at any time. A participant can leave the trial or refuse to take part in any aspect of the trial.

What should I ask to my Physician before participating in a trial?
Volunteers should know as much as possible about the clinical trial and feel comfortable asking at any time CRC staff about issues and questions related to any aspect of the study.

Here are some questions you might want to discuss with the CRC staff. Some of the answers to these questions can be also found in the informed consent document.

Why is the study being conducted?
What kind of tests and experimental treatments are involved?
How often do I need to come to the Clinical Research Center?
Who is going to be in the study?
What makes the researchers to believe that the experimental treatment being tested could be effective?
Are there possible health risks and/or side effects, involved in the study I am participating to?
How long will the trial last?
Who will pay for the experimental treatment?
Is insurance coverage being considered?
Will I be reimbursed for other expenses?
What kind of long-term follow up is part of this study?
Who will be in charge of my care?

Join Us!

Are you interested in participating as a volunteer in cutting-edge research, lead by top pharmaceutical industries and academic investigators? Do you wish to help further medical science while having access to new drugs and prior to their approval for marketing?

Join our database: s.cicolini@unich.it
Or, contact us: +39 0871 541 359

The CRC values the importance of bringing medical breakthrough to Society as quickly as possible, but does so following rigorously volunteer safety standards.

To ensure the safety of clinical trials, proposals must be reviewed and approved by both the:
- Ethics Committee of the University “G. d'Annunzio”
- CRC Advisory Committee

The Ethics Committee carefully evaluates proposals and makes sure that the risks involved in participating in any given trial are always significantly outweighed by potential benefits. The Ethics Committee reviews clinical trial protocols assuring sound scientific design and feasibility. It makes sure that protocols are completely compliant with National and European Community regulations.

The CRC Advisory Committee (AC) is composed of multidisciplinary faculty members with significant experience in clinical research. The AC provides oversight and monitoring of the performances of clinical trials and ensures total respect of patient's dignity and rights.