F.A.Q.

What is a clinical trial?
A clinical trial is a scientific study conducted in humans, whether patients or not, in order to assess the safety and effectiveness of new drugs, therapies, or medical practices. It aims to determine whether a treatment works, what its side effects are, and how it compares to others. It is carried out under strict regulatory and ethical guidelines.
Participating in a clinical trial gives people access to innovative treatments that may not yet be widely available. You contribute to medical progress and help improve care for future patients. Most participants receive close medical monitoring and support throughout the study. Participant involvement plays a key role in ensuring new therapies are safe and effective for the broader public. In many cases, there may be no-cost treatments or even compensation.
Selection is based on specific criteria called “inclusion and exclusion criteria” that help researchers find appropriate participants. These criteria may include age, gender, type and stage of disease, previous treatment history, and other medical conditions. Each trial has different requirements to ensure the study results will be meaningful and applicable to similar patients.
All clinical trials in Greece must follow strict regulatory guidelines and receive approval from the National Organiszation for Medicines and the National ethics committee. Before any trial begins, extensive laboratory testing and sometimes animal studies are conducted. Additionally, trials include safety monitoring throughout, with regular check-ups and the ability to withdraw if needed. While all medical interventions carry some risk, protocols are designed to minimize potential harm.
Informed consent is a process where you learn the key facts about a clinical trial before deciding whether to participate. It includes information about the study’s purpose, duration, required procedures, potential risks and benefits, and your rights as a participant. You’ll receive a document explaining these details and have opportunities to ask questions before signing. Remember that even after signing, you can withdraw from the study at any time.
Generally, the study sponsor covers the costs of the experimental treatment and any special testing or extra visits related to the trial. Regular standard care may still be billed to your insurance. Some trials offer compensation for your time, travel expenses, or other inconveniences. The exact financial arrangements will be explained during the informed consent process.
The duration varies widely depending on what’s being studied. Some trials might require only a single visit, while others may continue for years, especially for chronic conditions. The expected time commitment will be clearly explained before you enroll. Some studies also include a follow-up period after the main treatment phase is complete.
You have the right to withdraw from a clinical trial at any time, for any reason, without penalty. If you decide to leave, inform the research team so they can guide you through a safe withdrawal process and discuss alternative treatment options if needed. The research team may ask why you’re leaving, but you’re not obligated to explain.
Consider asking: What is the purpose of the study? What treatments will I receive? What tests and procedures are involved? How might this affect my daily life? What are the potential risks and benefits? What alternatives do I have? Who will oversee my care? How will my privacy be protected? Will I be informed about the results? Will I have costs not covered by the study? Who can I contact with problems or questions?
Yes, maintaining your relationship with your regular healthcare providers is important. The research team will typically communicate with your doctor about your participation. Your regular doctor can provide valuable insights to the research team and continue to manage aspects of your health not related to the study. Always inform both your doctor and the research team about any medications or treatments you receive.
A placebo is an inactive substance that looks like the treatment being tested but has no therapeutic effect. Some clinical trials compare an experimental treatment to a placebo to determine true effectiveness. If a study uses placebos, you’ll be informed during the consent process about the possibility of receiving one. Many trials, especially for serious conditions where standard treatments exist, compare new treatments to existing ones rather than placebos.
After a trial concludes, the research team analyzes the data collected. You’ll typically have a final assessment, and the team may share overall study results when available. If the experimental treatment benefited you, in some cases, you might be able to continue receiving it through a compassionate use program or extended access study, though this isn’t guaranteed. The research team will discuss options for continuing your care.
Your privacy is protected through several safeguards. Personal information is coded and kept confidential according to Greek and EU data protection laws. Results are typically published without identifying individual participants. The informed consent document will explain how your information will be used and who will have access to it. Ethics committees review these protections before approving studies.
Phase I trials test a new treatment in a small group (20-80 people) to evaluate safety and determine appropriate dosage. Phase II involves more participants (100-300) to assess effectiveness and further evaluate safety. Phase III trials include larger groups (1,000-3,000) to confirm effectiveness, monitor side effects, and compare to standard treatments. Phase IV studies occur after marketing approval to gather information on long-term effects in various populations.
Generally, participation in multiple clinical trials simultaneously is not recommended as it can compromise both your safety and the validity of study results. Multiple experimental treatments might interact in unexpected ways or confuse the source of any benefits or side effects. However, you may be eligible for a new trial after completing your current one, depending on the specific requirements.
Most clinical trials provide comprehensive support throughout your participation. This typically includes a dedicated contact person (often a study coordinator or nurse) who can answer questions and address concerns. Some trials offer additional services such as transportation assistance, counseling, or support groups. The research team aims to make your experience as comfortable and convenient as possible.
The research team will analyze data from all participants to determine if the treatment met its objectives regarding safety and efficacy. This process can take months or years after the trial concludes. Once analysis is complete, many sponsors publish results in medical journals and public databases. You can request to be informed about the overall findings, though these might not include your individual results. Success is measured not just by whether a treatment works but also by the valuable knowledge gained about the condition and potential treatments.
Side effects vary depending on the treatment being studied. Common side effects might include headaches, nausea, fatigue, or skin reactions. More serious side effects are possible but less common. The research team will inform you of known potential side effects before you join and monitor you closely throughout the trial. All side effects, whether expected or unexpected, should be promptly reported to the research team. Remember that identifying side effects is actually one of the important purposes of clinical trials.
Communication methods vary between trials, but most provide regular updates through scheduled visits, phone calls, or emails. Some studies have newsletters or secure online portals where participants can access information. Your study coordinator is your primary contact for updates and questions. While complete results may not be available until after the trial concludes, you’ll typically be kept informed about the overall progress and any significant developments that might affect your participation.
While you’re free to share your personal experience, there are important considerations. First, check your informed consent document for any specific guidance. Avoid sharing confidential information about the treatment or study procedures that might compromise the trial’s integrity. Consider using general terms rather than specific details about the experimental treatment. Remember that sharing your experiences could inadvertently influence other participants or potentially bias results if information spreads widely.
If you experience a medical emergency, seek immediate medical attention first, then inform the research team as soon as possible. Always carry your trial participation card with emergency contact information for the research team and information about the study. When seeking emergency care, inform healthcare providers about your participation in a clinical trial and any study medications you’re taking. The research team should have procedures in place for handling emergencies and will follow up with you afterward.
Clinical trials in Greece are regulated under European Union legislation (EU Clinical Trials Regulation 536/2014) and national laws. All trials must be approved by the National Organization for Medicines (EOF), the National Ethics Committee, and local institutional ethics committees. These bodies review the scientific merit, ethical considerations, and participant protections. Additionally, all trials must be registered in the EU Clinical Trials Register. Regular monitoring and reporting ensure ongoing compliance with these regulations throughout the trial’s duration