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What is a clinical trial?

Clinical trials are special research programs based on observation and evaluation of the effectiveness of using new treatment methods. Clinical trials also confirm the action, efficacy and safety of drugs - both those already in use and those just entering the market.

Is participation in clinical trials safe?

Yes. Participation in clinical trials is safe. The research is conducted in accordance with the GCP (Good Clinical Practice) principles. Compliance with this standard is a guarantee of data reliability and respect for the rights of persons participating in the research. The patient signs an informed consent to participate in a clinical trial, which he can withdraw at any stage without consequences, and the attending physician must stop the trial at the time of danger.

Is participation in clinical trials free?

Yes, participation in clinical trials is free.

What are the phases of clinical trials?

Before the drug is approved for sale in pharmacies, it goes through a clinical trial process, which consists of 4 phases. Each of them must be completed successfully so that the next stage can begin. Phase I initially assesses the safety of using the tested medicinal product. Most often dozens of healthy volunteers take part in it. Phase II the purpose of the second phase is to determine whether the new medicinal product works in a specific group of patients and whether it is safe. In this phase, a correlation between dose and drug effects is also established. Phase two trials include several hundred patients struggling with a given disease. Phase III is implemented with the participation of several thousand patients. The assumption of the third phase is the final confirmation of the drug's effectiveness in a given disease and checking the relationship between safety and effectiveness. Phase IV of clinical trials concerns medicinal products already registered and available for sale. It aims to determine whether the drug is safe in all indications recommended by the manufacturer and for different groups of patients.

What does the patient inclusion in the trial look like? Who decides about the eligibility?

Application for clinical trial in 5 steps: Step 1. Fill out the contact form. Step 2. Phone conversation with the Medical Information Center to conduct a medical interview. Step 3. The result of a telephone conversation may be an invite for a free visit to the Pratia Research Site. Step 4. After reviewing the medical records and laboratory results, the doctor decides whether to continue treatment as part of the clinical trial. Step 5. After talking to the doctor, the patient can make the decision to give their informed consent to participate in the clinical trial.

Who can participate in clinical trials?

A person who has been diagnosed with the disease and meets the inclusion and exclusion criteria contained in the clinical trial protocol may participate in the clinical trial. After reviewing the patient's medical records, the doctor may offer him / her participation in a clinical trial. After talking to the doctor, the patient gives informed consent to participate in the clinical trial.

Who will I be in contact with during the clinical trial?

The patient participating in the clinical trial has contact with the research team, i.e. doctors (primary investigator and co-investigator), nurses and the study coordinator. As part of participating in a clinical trial, the patient has 24-hour contact with people working in the trial.

What are my rights as a clinical trial participant?

The patient in the clinical trial has all the rights of the patient. In addition, at any time during participation in the study, the patient may opt out of participation without giving any reason.

Am I insured during a clinical trial?

Yes, a patient participating in a clinical trial does not lose insurance status. In addition, the sponsor conducting the clinical trial buys additional insurance for study participants.

Is it safe for me to take the test medicine?

The study drug is administered to patients under the strict control and supervision of the research team. In addition, the patient has constant health monitoring.

What if I'm treated with a placebo?

A placebo is a substance that looks and tastes like the tested medicinal product. Patients are informed about placebo-controlled studies before entering the clinical trial, i.e. at the stage of signing informed consent. Clinical trials are usually conducted with a double-blind method, which means that neither the patient nor the doctor knows whether the patient is receiving the study drug or a placebo. When the therapy does not bring any results, the attending physician decides to exclude the patient from the trial and directs him to specialist treatment.

Will I be able to opt out of the trial after deciding to participate in it?

Yes, at any stage of the clinical trial, the patient may withdraw his consent to participate in the trial without any consequences or giving any reason for doing so.

Will I incur additional costs for participating in the study?

No, participation in the clinical trial is free for the patient. The patient does not pay for visits, tests and medications in the clinical trial. He receives it free of charge as part of being a participant in the trial. In addition, in most studies, patients may be reimbursed for travel expenses.

How to prepare for participation in a clinical trial?

Before visiting the clinical research site, collect medical records of the diagnosed disease from medical facilities such as clinics, specialist clinics and hospitals.

What is patient's informed consent?

The patient's informed consent to participate in the study is a process that protects the patient's safety during the clinical trial. The patient gives his/her consent in writing on the so-called informed consent form in duplicate. One copy remains at the siteconducting the clinical trial, the other the patient takes with him/her. During the trial, the patient may withdraw informed consent at any stage.

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