ONCOLOGIC CLINICAL TRIALS AND RESEARCH CLINIC

What is a clinical trial?

A clinical trial is a procedure to study a drug’s safety and efficacy. A study drug is compared either to a placebo (pharmacologically inactive substance), when there is no standard treatment, or to current standard treatments to determine whether it is more effective and helps approve its market release and administration in daily clinical practice.

In settings where there is already a standard treatment with a proven survival benefit, a study drug is compared combined with the standard treatment versus standard treatment alone, to determine whether adding this new drug to the standard treatment would result to a greater survival benefit or disease response compared to that standard treatment alone.

How can a patient benefit from taking part in a clinical trial?

Being involved in clinical research offers multiple benefits, including receiving a high standard of therapeutic approach and monitoring according to a strict, internationally established framework that governs the clinical protocol of each study.

Through participation in clinical trials, the following are achieved:

1. Access to modern treatments that combine an internationally approved treatment with the addition of a new study intervention at no cost to the patient or their payer.
   All study patients have free of charge access to our Hospital’s services to undergo study-related tests and procedures (blood testing, imaging Trials, biopsies, One Day Clinic for the administration of the study drug, inpatient stay, medical and tumor follow-up by the study physicians).
   Depending on the requirements of the clinical research, patients often have the possibility to undergo modern imaging, laboratory, or genetic testing at no cost; such tests are particularly expensive and, occasionally, not covered by payers.
   Additionally, patient transportation costs to and from the Hospital and their accommodation are usually covered in many international clinical trials. This makes it easier for patients from all around Greece to access high-level treatment options during these challenging economic times.
2. The opportunity to access advanced and promising treatments earlier than they are marketed worldwide, provided that research demonstrates such treatments to have a therapeutic benefit in cure or overall survival improvement.
   This is a particularly important fact, especially for people with incurable, usually metastatic, malignancies.
3. The opportunity to receive treatments when standard treatment options are limited or exhausted.
4. The opportunity for uninsured people to receive the best standard treatment combined with the study intervention, in a prestigious hospital setting, at no cost.

NOTE: Participation in a clinical study is ONLY offered if this is actually the best possible disease-specific treatment option and ONLY after the prospective participant has received full and detailed information on the study. Participation in a clinical study IS VOLUNTARY. Participation in a clinical study is not binding, even if a participant has initially agreed and signed the Patient Consent Form. Participants may withdraw from the study at their discretion and/or the study physician’s discretion.

In international clinical trials, protocol-related supply of drugs and paraclinical tests are free of charge both for patients and their payer.

Early access programs

Early access programs refer to new drug therapies that have demonstrated their efficacy in treating target malignancies, have been approved by the US FDA (United States Food and Drug Administration) and/or by the EMA (European Medicines Agency), however, they are not currently on the Greek market, typically for pricing reasons.

Through such programs, one can have access to these interventions, much earlier than these are priced and prescribed. Thus, study drugs can offer their benefit sooner to people who need them at no cost (in some programs, even payers are not financially burdened, as the drug is provided free of charge by the pharmaceutical company that manufactures it - in this case, a program enrolls only a limited number of patients).

Early access programs are not clinical trials.

Research programs

There are active research programs on Prostate and Lung cancer.

How can I find out if I am eligible for a clinical trial, early access program, or research program?

You can search on the websites of Metropolitan General Hospital and Oncologic Clinical trilas and Research Clinic for Clinical Trials, Early Access Programs, and Research Programs that are currently open or anticipated to open. Then, you can get in touch with the Clinic's Oncologists to schedule an appointment and find out whether you might be able to participate in one of them, depending on the nature of your medical condition. *

If you are already under medical care, your attending physician can also inform you about the value of clinical trials and discuss your participation in one of them with you or refer you to someone from our Oncologic Clinical Trials and Research Clinic Team.

*you can also send any inquiries or questions you may have about our Clinic’s ongoing Clinical Trials, Early Access Programs, or Research Programs to the e-mail below: OncoCTR.Clinic@yahoo.com