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Participation in Phase I studies

The Campus Bio-Medico University Hospital is a reference centre for the study of new drugs. Some of these studies, so-called Phase I Studies, involve the administration of a new drug to healthy volunteers or to individuals who are already suffering from the disease the drug is designed to treat.

 

During Phase 1 studies, the distribution of the drug in the human body is analysed by taking small samples of blood (similar to the volumes taken for normal medical examinations). Phase 1 trials are conducted under conditions of maximum safety. Before moving on to the Clinical Trials phase, each new drug must be tested against a series of experimental models to show that it is tolerable, and also have successfully passed the relevant manufacturing quality checks. The manufacturer must have also been given permission for the drug to undergo testing from the national regulatory authority. During the study phase, the drug will be administered in primarily very low doses.

 

Anyone participating in a Phase I study at the Campus Bio-Medico University Hospital will do so in a welcoming and comfortable setting. The studies are carried out either on an outpatient basis or at a special Clinical Trials Unit which meets the requisite international standards.

 

Participants in a Phase I trial receive guaranteed insurance cover, financial compensation proportional to the time they are able to devote to the study, and various free medical checks, hence providing them with the opportunity to monitor their own state of health free of charge. Volunteers are also individually monitored by specialists at the University Hospital with specific competence in the study of new drugs.

 

By taking part in a Phase 1 study, you will be able to make your own contribution towards scientific progress in the interests of human health.

 

If you would like to receive information about Phase I trials that are either already underway or in course of preparation and would like to take part, please contact us:

 

   |  Fax: (+39) 06.22541.456

 

(IMPORTANT: please mark your fax for the attention of Professor Giorgio Minotti).

 

 

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