What are clinical trials?

These are programs of research on already used or new drugs, which are carried out in order to confirm their effectiveness, extend therapeutic indications and safety of use. Around the world, hundreds of thousands of patients each year participate in such studies. Approval for their conduct is issued by appropriate institutions: the independent Bioethics Committee, the Minister of Health, additionally the test is registered in the Central Register of Clinical Trials. These institutions constantly monitor clinical trials, ensuring their proper course.

The research is carried out by the Chief Researcher / Principal Investigator – a specialist doctor with the highest professional qualifications and experience in diagnosing and treating patients. Before treatment, each patient is informed in detail about the course of the study (medications taken, diagnostic tests performed, frequency of follow-up visits, duration of individual visits and the entire study, etc.) and gives their informed consent to participate in the clinical trial.

The introduction of innovative methods of treatment over several years has resulted in significant progress in the prevention and therapy of diseases that are an age-old problem in medicine. A patient participating in a clinical trial does not bear any costs of treatment and diagnostics provided by the clinical trial protocol. There is a possibility of reimbursement of travel costs to the center for individual control visits.

Who can take part in a clinical trial?

A person suffering from a specific disease and meeting the so-called inclusion criteria that are included in the study protocol. The decision about inclusion in a clinical trial is made by the attending physician-researcher who recruits patients for the trial.

Before deciding to enter a clinical trial, the patient should obtain as much information as possible about the trial in order to be able to give free, informed consent to participate in the clinical trial.

How to apply for a clinical trial?

Each test has a precisely defined so-called inclusion criteria and exclusion criteria. They tell you what conditions must be met in order to be included in the study and what factors make it impossible to take part in the study. It should be very clearly stated that according to the requirements of Good Clinical Practice (GCP), only the attending physician (researcher) is entitled to include the participant in a clinical trial, so he will make the final decision.

PATIENT SAFETY / BENEFITS

By participating in the study, the patient has a chance to benefit from commonly unavailable methods of treating many diseases, especially chronic diseases.
Detailed examinations are performed in the patient participating in the study, often not available in primary or even specialist medical care.
A patient in the program (clinical trial), apart from contacting his doctor, is covered by free medical care in the center conducting the clinical trial, and if necessary, he / she receives free consultations with specialists.
Throughout the course of the study, the patient is under the care and daily contact of the doctor who conducts the program and under the supervision of the principal investigator. During the course of the study, the safety of patients and the effects of drug side effects are monitored on an ongoing basis, and if disturbing events are noticed, the study is terminated.
At any time during the study, the patient may withdraw consent to participate in the program without giving a specific reason.
If anything abnormal or disturbing occurs during the program, the attending physician decides to exclude the patient from the study.
Patient travel expenses for visits are reimbursed

CURRENT CLINICAL TRIALS

FORMULARZ KONTAKTOWY

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Wyrażam zgodę na przetwarzanie przez firmę Małopolskie Centrum Kliniczne moich danych osobowych zawartych w powyższym formularzu rejestracyjnym w celu mojego ewentualnego uczestnictwa w bieżących i przyszłych rekrutacjach do badań klinicznych realizowanych przez firmę Małopolskie Centrum Kliniczne która obejmuje także kontakt drogą elektroniczną (email, sms) i kontakt telefoniczny ze mną jako ochotnikiem do badań klinicznych. zgodnie z ustawą z dnia 18.07.2002 r. o świadczeniu usług drogą elektroniczną (Dz.U. Nr 144, poz.1204 z późn. zm.) i Art. 6 ust. 1 lit. f RODO.
Wyrażam zgodę na przetwarzanie danych osobowych, medycznych i danych o stylu życia do celów pełnej realizacji procesu rekrutacji do badań klinicznych, zgodnie Art. 6 ust. 1 lit. A, c, f RODO oraz art. 9 ust. 2 lit. a RODO w zw. z art. 37 f, a ustawy Prawo farmaceutyczne.
Wyrażam zgodę na przesyłanie mailem lub smsem ofert marketingowych zgodnie z Ustawą z dnia 18 lipca 2002 r. o świadczeniu usług drogą elektroniczną (Dz.U. 2017, poz. 1219).