For patients

Clinical trials are a responsibility.
It’s a courage to look further.

We choose this courage every day, together, for the patients.

Participating in trials, patients not only support an individual treatment process, but also contribute to the science development, potentially affecting the life of millions of people in the whole world!

What are clinical trials:

Clinical trials are precisely planned scientific studies conducted with the participation of people, aiming at getting understanding of how new medical therapies work. Trials allow to determine how safe and effective used drugs are, specify correct doses, and identify potential adverse events. A key element is to ensure that benefits resulting from using a drug outweigh potential risks.

Before being registered and introduced to the market, every drug must undergo several stages of clinical trials. These trials also allow for the identification of new applications for already registered drugs. Conducting clinical trials requires the approval of the relevant regulatory authorities, such as the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, and a positive opinion from the Bioethics Committee. Patients’ participation in these trials is completely voluntary.

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What are the benefits
of participating in a clinical trial?

Participating in a clinical trial is not only a chance, it’s also a decision that can change your life, actually contribute to the development of world’s medicine, and give you access to the highest quality care.

Access to innovative therapies

– before they are available in the pharmacies.

It is especially important in chronic, rare, or standard-treatment-resistant diseases.

Expert care of the
specialists’ team

Each decision is consulted, thought through, and compliant with international guidelines.

Free-of-charge and
complex health care

In many cases, the quality of care outweighs the standard outpatient pathway thanks to more intensive monitoring and access to modern diagnostics.

What can you expect?
The course of the trial,
step by step

For many patients, the biggest barrier is the lack of knowledge on what happens during the trial. From the first contact, to the very last visit, you will be under the care of an experienced team, which will carefully and considerately direct you through every stage.

Informacje dla pacjenta | Penta Hospitals Badania Kliniczne

1

Registering your
willingness

to participate starts with a conversation

Pomieszczenia dla zespołu monitorującego i koordynatorów

2

Medical
verification

Can you participate?

3

Signing the informed consent

4

Participating in the trial

We are with you on every stage

5

End of participation and the follow-up support

Trust is built on transparency

Learn about your rights and safety during a clinical trial.

Informed
consent

A decision to participate in a trial is taken only after reading all information about the trial, its course, benefits, and risks. You make this decision voluntarily, without any pressure from us.

Right
to withdraw

You have a full right to withdraw from participating in the trial in any moment, without providing any reason and with no negative consequences. Your decision is always respected.

Safety
monitoring

During the trial, we continue monitoring your health and reactions of your organism. In the case of appearing adverse events or warning signals, we react immediately, providing you with full medical support.

Your
data protection

Your personal and medical data is protected pursuant to the GDPR regulations. We ensure complete confidentiality and safety, and the access to data is only given to authorized persons. All data is anonymized to protect your privacy.

Do you have any questions?

Talk to us

Questions
and answers

Who can participate in trials?

Clinical trials are a medical process in which only individuals who meet specific requirements can participate. The most important of these is meeting the criteria and medical assumptions strictly defined in the trial plan. If you apply for the trial, your doctor will decide whether it is safe for you to participate. They will also assess the potential risks of participating in the trial.

What is an informed consent?

Informed consent is essential for the participation in any clinical trial. Before you decide to participate, you must understand all the details that may apply to you. The doctor conducting the trial will provide you with the necessary information and only based on it will you make your final decision. If you agree to participate, you will sign two copies of the informed consent in the presence of the doctor – one for you and one for the study records.

What is the course of participating in a clinical trial?

Participating in the trial is divided into several stages. In the first stage, you will receive all necessary and interesting for you information related to the trial. This is the best moment to ask questions to the doctor that might address all your doubts.

In the second stage, you make a decision and sign the consent to participate in the trial. Remember that joining the group of trial participants is related to certain obligations. You have to observe all doctor’s recommendations and follow the information included in the trial information form. It is also your responsibility to inform about your health status.

The third and the most important stage is the trial itself. The condition of your health will be controlled by the trial doctor at all times. Specialists will carry out analyses and laboratory tests, measure vital signs and implement specialized procedures required by the protocol (e.g. computed tomography, MRI, X-ray, biopsies, neurological and ophthalmological examinations). You will also have access to the results of your tests performed for the project. During some tests, participating patients are required to keep a trial diary in which they record any symptoms of disease.

What are the benefits of participating in a clinical trial?

Participating in a trial, you mostly gain access to medical care, and the condition of your health is constantly examined and assessed. It is often done with the use of devised and diagnostic methods that are unavailable or difficult to access in standard medical care.

Apart from that, you significantly help doctors to gain knowledge which might one day save life or health of other people.

Do I have to pay for participating in the clinical trial?

Participation in clinical trials is completely free-of-charge at all stages. Participants are reimbursed for any expenses incurred (e.g. related to travelling to a medical facility for appointments). Our team will discuss reimbursement policies during the study.

Is there any danger related to participating in the clinical trial?

Our clinical trial centres are supervised by proper authorities and subject to all required legal regulations.

Each clinical trial participant is the strict supervision of the specialist doctors conducting the trial throughout its duration.

Using any drug is related to a risk of adverse events. However, before joining the trial you get all available information about any danger.

Remember that during the whole process of the trial, the condition of your health is monitored and assessed by a specialist. If they decide that you are not befitting from the participation in the trial, they will offer you to end your participation in the trial. What is more, you can also withdraw from the trial at any time in case of any doubts.

Can I withdraw from the clinical trial?

You can withdraw from the trial at any time, at any stage, without any consequences. Please also remember that your doctor may decide to exclude you from the trial. This happens if the risk of the study impacting your health is too high.

What are the requirements to participate in a clinical trial?

Requirements regarding participating in the clinical trial can vary depending on specific criteria of a given trial. Generally speaking, participants must meet specific health-related and demographic criteria, such as specific age, no contraindications to the use of the tested substance. To learn more, please contact the research site conducting the trial directly.

What are clinical trials?

Clinical trials are precisely planned scientific studies conducted with the participation of people, aiming at getting understanding of how new medical therapies work. Trials allow to determine how safe and effective used drugs are, specify correct doses, and identify potential adverse events. A key element is to ensure that benefits resulting from using a drug outweigh potential risks. Before being registered and introduced to the market, every drug must undergo several stages of clinical trials. These trials also allow for the identification of new applications for already registered drugs. Conducting clinical trials requires the approval of the relevant regulatory authorities, such as the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, and a positive opinion from the Bioethics Committee. Patients’ participation in these trials is completely voluntary.

Is participating in a clinical trial safe?

Participants’ safety is absolute priority of every clinical trial.
Before starting, each research project undergoes rigorous review by independent bioethics committees and regulatory authorities. Trials are conducted in accordance with international Good Clinical Practice (GCP) principles, which guarantee the highest standards of participant protection.
Additionally, the patient is under the care of a qualified team of doctors, nurses, coordinators, and pharmacists throughout the trial. Any changes in health condition are carefully monitored and documented, and any adverse events, regardless of their nature, are immediately analysed and reported. Before you decide to participate, you will receive a full set of information—in an accessible format—and time to reflect and ask questions.

Can I withdraw from the clinical trial in any moment?

Definitely yes. Participating in the clinical trial is completely voluntary.
You have the right to withdraw from participation at any time, for any reason, without any legal or medical consequences. Your decision, at any time, will be respected with full understanding and respect.

Is participating in a clinical trial related to any costs?

No. There are no fees related to participating in a clinical trial. All medical procedures related to the trial, including consultations, laboratory tests, diagnostic imaging, and medications, are funded by the sponsor. Patients are also reimbursed for travel expenses to and from appointments.
This is to ensure that participating in the trial is as stress-free as possible, while ensuring that you feel treated with care, attention, and professionalism.

How can I register to a clinical trial?

It’s easy. You can contact us by phone, email, or directly via a form on our website. After you register, our team will contact you for a short interview to check if we are currently conducting a trial that is relevant to your health condition. If we are, we will invite you for a qualification visit, during which the doctor will explain all details.
If we aren’t currently conducting a trial that’s suitable for you, with your consent, we’ll retain your contact information and get back to you when a suitable project becomes available. We believe that every patient deserves access to modern therapies, and we’ll do everything we can to make the registration process clear, safe, and convenient for you.

What should I do before the first visit?

Your first visit at our site may seem surprisingly long, but don’t hold that against us. We care about you, and such a detailed examination, interview, and numerous procedures are essential to provide you with the best possible care. The first visit is usually time-consuming and rarely requires an empty stomach. However, if you need to fast, your doctor will inform you in advance. Our doctor will advise you when you should fast, so don’t bother coming to us without breakfast. Remember, however, to bring your reading glasses if you use them.

During your first visit to our site, your doctor will conduct a specialist consultation. They will check a medical history about your condition, so please prepare the following information:

– available documentation regarding your disease (including hospital discharge summaries, diagnostic test results, etc.). If possible, ask your specialist for a copy of your medical records; as a patient, you always have the right to this, but sometimes it may be necessary to wait a few days or pay for a photocopy, in which case we will reimburse you for the cost.

– Be prepared that your doctor will ask for the following information (that is why it’s best to have documentation):
+ date of diagnosis,
+ treatment history (it’s important to know the dates),
+ surgeries (including those unrelated to your condition).
– also, prepare a list of all medications you’re currently taking, as your doctor will ask you not only for the name of the medication, but also about the dose, how long you’ve been taking it, and why.

If you decide to participate in the trial, remember to inform your doctor about any illnesses, new medications, or hospital stays. This is important for us to provide you with appropriate care.

Is psychedelic therapy used in Poland only within the framework of scientific or clinical research?

Yes, currently, psychedelic-based therapy is conducted in Poland only within scientific research, including clinical trials. According to currently applicable law, psychedelic substances such as psilocybin, 5-MeO-DMT, and MDMA are not approved for general medical use and may only be used under strictly controlled research conditions. These trials aim at assessing the safety and effectiveness of these substances in treating various disorders, such as depression, anxiety, and post-traumatic stress disorder (PTSD). All trials are conducted according to rigorous guidelines and require approval from relevant regulatory authorities and bioethics committees. -> click to add information about psychedelics on the Site’s website

How to participate
in clinical trials

Step 1

Registration

Do you want to participate in a clinical trial? It’s simple. You just need to fill in a short registration form. Our team will contact you for an initial interview to check if the trial is suitable for you. Don’t worry, we will answer all your questions!

Step 2

Appointment with a doctor

After the initial qualification, we will invite you for an appointment with a doctor conducting the trial. The doctor will be available for you to tell you more about the trail, discuss any possible doubts and check the condition of your health.
The appointment is free-of-charge and non-committal.

Step 3

Decision

You are completely free to make your own decision about participating in the trial. After the meeting, you will have time to think through all the information. If you decide to participate, we will sign suitable documents and get you ready for next steps.

Step 4

Participation in the trial

After you make a decision, the actual part of the trial starts. You can always count on our support and use regular consultations.