Clinical Trials

A clinical trial is a scientific investigation conducted on patients in order to identify specific responses to new therapies/procedures, or new ways of using known treatments. Clinical trials provide a great contribution to knowledge and progress in the fight against many diseases. Many of today's most effective treatments are the result of extensive studies and clinical trials that often suggest new directions for future research. IEO has always been engaged in conducting clinical trials, often in collaboration with leading international research institutes.

What a Clinical Trial is

The term "Clinical Trial" means a scientific research aimed at patients with the objective of identifying specific responses to new therapies or procedures, or new ways of using known treatments.

Why Clinical Trials are important

Clinical Trials provide a great contribution to knowledge and progress in the fight against many diseases. Many of the current most effective therapies are the result of extensive studies and clinical trials, that, in addition, suggest new directions for future research.

How one can participate to a Clinical Trial

Every clinical trial is based on a set of rules, called the protocol. The protocol describes the characteristics of the people who can be treated within the framework of a clinical trial, the program, logistics, the necessary tests and examinations, the details on the treatment and the study duration.

To verify if a person can be enrolled onto a clinical trial, a careful program of tests is set up in order to determine whether all the study requirements are met. The inclusion criteria define the eligibility to participation on the clinical trial while the exclusion criteria are those describing non-eligibility. It is important to emphasize that these criteria are essential in identifying the most appropriate people for the trial and ensuring their safety, and that these criteria have no discriminatory intent, but rather that they allow us to achieve the best information for patient care. The study program schedules regular appointments carried out by the personnel involved in the research to monitor the patients’ health and to evaluate the safety and efficacy of the treatment.

What kinds of Clinical Trials exist

Clinical studies may relate to all research areas, prevention, diagnosis and treatment of cancer, aspects of the quality of life, symptom control, and psychological aspects of patients and their families.

Clinical Trials testing new treatments are classified in phases. Each phase depends on the previous phase results and is realized on the basis of the discoveries made from time to time:

Phase I is aimed at assessing the safety of the dose and the biological effect of a new drug or therapy.
Phase II is for a further assessment of safety and efficacy of the therapy.
Phase III is aimed at confirming the efficacy in the long term, comparing the new therapy with the standard clinical practice.
Phase IV is the application to various populations.

There also clinical studies conducted to evaluate surgical techniques and medical devices, or observational studies that require no specific classification and are defined as studies without pharmacological intervention, aimed at the simple observation of the experimental data.

How participants in a Clinical Trial are protected

Scrupulous guidelines have been set to duly protect patients choosing to participate in a Clinical Trial. All studies conducted at IEO are firstly approved and monitored by the IEO Ethical Committee, in order to guarantee that risks are minimized and that they are significantly less than the potential benefits.

The IEO Ethical Committee, the body responsible for safeguarding the rights of patients, evaluate the scientific merit of a research study, its scientific importance, the adequacy of the experimental design, the statistical analysis, and the risk/benefit ratio.

The IEO Ethical Committee is an independent committee consisting of physicians, pharmacists, nurses, bioethicists, legal experts and other experts that guarantee that the study is ethical and the rights of the participants are preserved.

All the Institutions conducting biomedical research that involves human beings are required by law to provide for an Ethical Committee, such as at IEO, which approves each study and revise it periodically.

INFORMED CONSENT AND PRIVACY
Patients must be fully informed about the trial aims and the protection of their rights, before entering the study.

Candidates have to be fully informed that they have a number of rights, both before agreeing to participate and during the trial. The process by which participants are made aware of the main aspects of study before deciding whether to participate or not is called “informed consent”; the participant is given a document written specially for the clinical trial and approved by the Ethics Committee that he/she has to sign after accepting to participate. Candidates receive information about the protection of their rights, when they are offered to participate in a clinical trial.

This document includes the following information:
- definition of the population involved in the study;
- research objectives;
- study logistics, including tests, therapy, treatment duration and follow-up period;
- possible benefits;
- potential risks;
- therapeutic alternatives.
The “Informed Consent Form” expressly states that the patient may withdraw from the treatment whenever he or she wishes it. Subjects who refuse to participate or who withdraw from the study at any moment will be treated without prejudice.

The possibility to participate in Clinical Trials is part of the discussion between the research team and the patient as part of their regular interactions.

Before signing the Informed Consent Form, participants must have sufficient time to clarify any doubts on the proposed trial and discuss it with their family and/or their General Practitioner.

If a patient decides to participate in the study, the Informed Consent Form must be signed simultaneously by both patient and physician investigator. After the signature of the Informed Consent Form, the patient will receive a copy of this document.