Why are clinical studies conducted?

Clinical studies constitute a response to the needs of broadly understood medicine - an attempt to find an effective way to treat and diagnose diseases that we still cannot fully cope with. The purpose of clinical studies is to test new, thus far unknown and unavailable on the medical market methods of diagnosis or treatment in terms of effectiveness, usefulness, and safety for patients.

Each new substance that seems to have therapeutic potential is repeatedly tested in laboratory tests and animal studies. Only after passing all laboratory tests and documenting their results, and after obtaining approvals from the Bioethical Committees and offices exercising control over drugs on a national and/or global level, it is possible to start a phase I clinical study. .

A new form of treatment cannot be introduced, that is, registering a drug or admitting a new method of diagnosis or therapy, without a clinical study.

Are a clinical study and biological therapy one and the same thing?

Currently, biological treatment is mainly carried out in the so-called "drug programs" under the National Health Fund (free-of-charge for the patient, paid by the National Health Fund). Qualification for a drug program is very similar to the case of a clinical study (appropriately high disease severity and/or presence of complications, ineffectiveness of previous treatment, no severe infections). The difference is that in the biological treatment program, only biological drugs are administered t... (zobacz więcej)hat have already been approved... (see more)for treatment in a given disease entity and are available for sale.

Of course, in a clinical trial you can also be placed in a group in which a drug already approved for marketing is administered, but you can also receive a research drug that is currently in the testing phase or a placebo (a substance that does not affect health - e.g. saline or glucose solution ). All of this depends on the structure of the study. In most clinical studies, a patient who has received a placebo has the option of receiving the drug later in the study.

Biological treatment programs currently treat various autoimmune diseases, not only inflammatory bowel diseases (ulcerative colitis and Crohn's disease) but also rheumatological and allergic diseases. Biological drugs are also used in oncology, hematology, cardiology, and dermatology. The only way to receive a drug under the biological treatment program is to apply to the National Health Fund (NFZ in Poland) facility conducting biological treatment and go through the qualification process.

At the Melita Medical Center, we do not run biological treatment programs on the National Health Fund - in our facility, you can participate in clinical trials of new biologicals as well as "non-biological" drugs. (zobacz mniej)

Is participation in a clinical study free of charge?

The patient's participation in the study is completely free of charge, the patient cannot incur any costs in connection with participation in it. Therefore, costs related to travel to the center are reimbursed and, if necessary and at the discretion of the Sponsor, other costs that the patient might have to incur.

THE PATIENT DOES NOT RECEIVE ANY REMUNERATION FOR PARTICIPATING IN THE STUDY.

Is participation in a clinical study free of charge?

Can I agree to only some procedures as part of a clinical study?

By signing the informed consent form, the patient agrees to participate in all procedures provided for in the clinical trial. In practice, this means that he cannot choose the number of blood draws or endoscopic examinations that he will have to undergo, or refuse to complete the disease symptom diary if keeping it proves to be burdensome for the patient. Therefore, as a rule, refusal to participate in one of the study procedures means withdrawal of consent to participate in the entire study and, at the same time, termination of treatment.

In some clinical studies, additional blood tests or tests are carried out if the patient agrees to take part in them. For example, an extra vial of blood may be taken for genetic testing, an additional biopsy taken during a routine endoscopy, or an additional visit with blood drawn for pharmacokinetic testing. Sometimes participation in the optional part of the study may require an additional time commitment from the patient (e.g. visiting the Center between visits to collect blood), so it is worth reading the optional part of the consent carefully and asking the staff of the Center for details. The patient may not consent to optional procedures and this does not entail any consequences - it is enough to select the appropriate option in the appropriate place of consent.

Of course, it should be remembered that at any time during the study, the patient may withdraw their participation providing any reason - just communicate your decision to the treating physician or study coordinator and decide whether you want to participate in the observation part of the study.