Frequently Asked Questions

Our frequently asked questions guide will clarify any doubts you have regarding clinical trials as a patient, and hopefully motivate you to join our studies at Sanos.

What is a Clinical Trial?

Clinical trials are research studies regarding the safety and efficacy of medical treatments in humans. They are an important for promoting medical knowledge and patient care, therefore crucial in diagnosing and reducing the risk of diseases, as well documenting how new treatments work. These studies may also show which medical approaches work better in certain conditions, illnesses or groups of patients.

Signing up for clinical trials may benefit medical research and help future generations, but in many instances, clinical trial patients also gain personal benefits, as improved disease outcomes or better health care.

If you take part in a clinical trial, you may have more tests and medical examinations than you normally do with your own doctor. The purpose of these exams is research, so the studies follow strict rules and standards that ensure patient protection and safety.

What are the phases of Clinical Trials?

There are four phases in clinical trials and each phase serves a different purpose in helping researchers answering different questions.

• In Phase I the medicine is tested to evaluate safety, identify possible side effects and what is the safe dosage. This treatment is usually tested in small groups of healthy patients.
• Phase II the medicine is tested for effectiveness, so it is given to large groups of patients with a specific disease.
• In Phase III researchers compare the results of the new medicine with common treatments already existing. The treatment is given to large groups of people so that it is easier to confirm the effect and make the comparison.
• Phase IV is conducted when the treatment in test is approved and on the market. The goal is to identify the its impact in the long term, including optimal use, benefits and treatment risks.

Who can participate in a Clinical Trial?

Everyone can participate in clinical trials, but some of them need to enroll patients with a certain condition or disease, while other enroll healthy people to ensure new approaches to diagnosis, prevention or screening. Each trial must only include patients that fulfill the study criteria, such as patients with a certain age or gender, patients that have received certain treatments or have some specific health problems. Before joining a clinical trial, the participants will be screened in order to qualify for the study.

All attempts are 100% volunteer and you can withdraw for the study at any time without affecting your usual treatment.

How can I register for a Clinical Trial?

If you are interested in taking part in a clinical trial you can register in your website by going to Register for a Clinical Trial and choosing the trial you want to participate. Alternatively, you can book a meeting at our clinic and directly talk to our research members about your registration. Please see our address and phone number in contacts.

How are patients protected in a Clinical Trial?

Before our clinical trials begin, all participants are introduced to an informed consent. This is the process of learning about the clinical trial before you decide to take part in it. Signing the consent means that you agree to participate in that study and that the research team has explained you the trial’s purpose, how long it will take, what will happen, all potential risks and benefits if any, and information about your rights.

Even if you have signed the consent, it is still possible to withdraw it and leave the study.

What are the benefits and risks associated with Clinical Trials?

Participating in clinical trials has many benefits. Firstly, you are helping to gather medical and scientific information, which consequently will be important in the process of medical care advance and help others patients improving their living conditions. Not only that, but you may have access to new treatments before they are available to the regular patients, thus making you part of the first group getting its benefits.

Before beginning a clinical trial, our health professionals will inform you about the potential risks that may occur during your participation. These may include side effects, adverse reactions to the medicine in study or even no changes to your condition. There is strict supervision and control in our studies, so if there would be any complications that constitute a risk to our patients, the clinical trial will be stopped or put on hold until the possible risk is resolved.

What are my responsibilities as a Clinical Trial patient?

As a clinical trial patient in our studies, you are expected to comply with the studies’ requirements, which include:

• Read the consent form and other documents, and ask questions if you do not understand something about the study. It is important for us that you fully agree with the study before registering.
• Follow directions for proper use, dosing and storage of self-administered study medications.
• Inform the clinic about any negative experiences or side effects you have while participating in the studies.
• Show up at scheduled appointments on time or inform the clinic within a reasonable time if you need to reschedule the appointment.
• Provide truthful answers to questions asked during the study.

If you decide to withdraw from the study, inform the clinic and follow the procedures for withdrawal.

What is a control group?

During clinical trials patients are normally divided in two groups. One group will receive the new medicine, while the other group (called the control group) will receive either approved standard treatment for the disease or some treatment with no effect (called placebo). This is done in order to compare the effects of the new medicine in study, to the already approved medicines or to no treatment at all (the placebo).

Can a patient leave a Clinical Trial?

A patient participating in a clinical trial can leave the study at any time. In order to help our research, patients leaving a study can be invited to a brief meeting, which they can also choose not to attend.

Do I have to pay to participate in a Clinical Trial?

Participating in our clinical trials has no costs for our patients. Sanos Clinic cover all expenses associated with clinical trials, including the medicine being tested and the medical procedures and exams.

If you have any other questions, please contact us by calling +45 7370 8200 or by sending an e-mail to info@sanosclinic.com

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