In our Medical Center, the initial qualification for a clinical trial begins during a medical visit - first, the doctor checks the patient's medical record in terms of the duration of the disease, previous treatment, and concomitant diseases. If the doctor decides that we currently offer a treatment that could be a good solution for the patient (better than standard pharmacotherapy), he initially discusses with him the basic aspects related to the course of the study and issues an Informed Consent Form for you to read.... (zobacz więcej)
When the patient becomes familiar with the issued document and informs the Center about their willingness to participate in the study, an appointment is arranged with the signing of the Informed Consent and the period of proper qualification for the study described above begins.Currently at the Melita Medical Center, we are recruiting for clinical trials in the following indications:Clinical Study Qualification
In order to participate in a clinical trial, a patient must pass the qualification process - this means that he/she must meet a number of criteria set by the Sponsor.
The time when these criteria are checked is called the "screening period" or "screening".
Every clinical study has its own unique criteria, but some of them can be considered universal, and these include:
Signing the informed consent form and the willingness and ability to adapt to the schedule of study visits Properly confirmed diagnosis of the underlying disease to be treated in the clinical trial (e.g. in a hospital discharge card or from a specialist doctor, confirmed by test results) Stable medical history - if the patient has concomitant diseases, they must be well controlled with constant doses of drugs Stable treatment of the underlying disease - no treatment or stable doses of appropriate drugs Appropriate severity of symptoms of the underlying disease (usually at least moderate) no ongoing severe infections (especially those requiring hospitalization) No deviations in the results of laboratory, imaging and/or endoscopic tests that may threaten the patient's health or indicate an undiagnosed new disease Participation in the study must be in the best interest of the patient and must not endanger their life or health... (zobacz więcej)
Depending on the study, screening may take from a week to 2 months. The time required for all tests and checking the patient's documentation is always imposed top-down by the study Sponsor. Naturally, the patient can receive the drugs earlier than the maximum time allowed for screening, as long as all the required procedures can be carried out in this shortened time.
After all the tests required by the protocol have been conducted and it has been made sure that the patient meets all the criteria for inclusion in the study, the screening period can be closed and the patient can be given drugs under the so-called "randomization visit" or "visit 0".
The time when these criteria are checked is called the "screening period" or "screening".
Every clinical study has its own unique criteria, but some of them can be considered universal, and these include:
Signing the informed consent form and the willingness and ability to adapt to the schedule of study visits Properly confirmed diagnosis of the underlying disease to be treated in the clinical trial (e.g. in a hospital discharge card or from a specialist doctor, confirmed by test results) Stable medical history - if the patient has concomitant diseases, they must be well controlled with constant doses of drugs Stable treatment of the underlying disease - no treatment or stable doses of appropriate drugs Appropriate severity of symptoms of the underlying disease (usually at least moderate) no ongoing severe infections (especially those requiring hospitalization) No deviations in the results of laboratory, imaging and/or endoscopic tests that may threaten the patient's health or indicate an undiagnosed new disease Participation in the study must be in the best interest of the patient and must not endanger their life or health... (zobacz więcej)
Depending on the study, screening may take from a week to 2 months. The time required for all tests and checking the patient's documentation is always imposed top-down by the study Sponsor. Naturally, the patient can receive the drugs earlier than the maximum time allowed for screening, as long as all the required procedures can be carried out in this shortened time.
After all the tests required by the protocol have been conducted and it has been made sure that the patient meets all the criteria for inclusion in the study, the screening period can be closed and the patient can be given drugs under the so-called "randomization visit" or "visit 0".
