Clinical trials

Why are they conducted?
 

To confirm that the therapy really works (fewer relapses/slower progression) and to determine its safety profile. This is especially important in MS, as there are currently more than 20 approved DMTs (disease-modifying therapies), and research helps to identify the best options and their place in the treatment sequence. 
To provide evidence-based justification for the use of a drug or method, government agencies or registration agencies require data from studies to make a decision on registration. In order for a new drug to be approved for medical use in a country, it must usually undergo several stages of clinical trials — only then will the registration authority grant approval.
 
 
 How are studies (phases) organized?
 
 Phase I — safety and dosage.
 
 Phase II — does it work in people with MS and preliminary safety.
 
 Phase III — confirmation of efficacy/safety in a large sample before submission for registration.
 
 Phase IV — post-marketing: long-term efficacy/safety.
 
Are there placebos?
 

Yes, sometimes a new drug is compared with a placebo or standard therapy; this is done ethically, with informed consent, and helps to honestly assess the benefits/risks. 
 
How can you get into a clinical trial?
 

1. Information: Research centers, clinics, and doctors often advertise open clinical trials. For example, a patient can ask their specialist if there are any trials for their condition.

2. Participation criteria: Studies have clear inclusion and exclusion criteria—age limits, disease stage, comorbidities, presence or absence of certain treatments.
 
 3. Informed consent: Before participating, you will be explained what will happen, what the risks may be, and you will sign an informed consent form.
 
4. Regular monitoring: Study participants undergo examinations, tests, possible changes or monitoring of medication/therapy, and data collection on results and side effects.
 
5. Right to withdraw: Participants have the right to withdraw from the study at any time. 
 
 
If you are undergoing treatment but are currently ill and your doctors are discussing the option of participation, it is important to discuss with your doctor what the benefits are, what the risks are, and how it will affect your current treatment.
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What are the first steps? 
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1. Discuss with your neurologist whether you meet the inclusion/exclusion criteria. 
 
 2. Find active trials:
 

• Information on clinical trials in Ukraine can be found on the website of the State Expert Center (SEC) of the Ministry of Health of Ukraine, in particular at https://clinicaltrials.dec.gov.ua. This resource provides data on current studies according to various criteria, such as disease, location, and drugs. News and reports on the status of clinical trials are also available on the SEC's official Facebook page.  

• EU Clinical Trials Register / CTIS — trials in EU/EEA countries.

• Ask at your hospital or regional hospitals, in the neurology departments.
   

 1. Contact the study coordinator (contact details are available on the trial page) and undergo screening.
 
 2. Sign an informed consent form describing the objectives, procedures, risks, confidentiality, and your right to withdraw from the study at any time.
 
 
Benefits of participation: more frequent monitoring (neurologist/MRI), access to innovations, contribution to science. Possible risks: side effects, additional visits/time, chance of receiving a placebo. The decision is made jointly with your doctor.
 
What are the possible risks and what should be considered?
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•  Temporary uncertainty. Even if the drug has undergone laboratory and preliminary studies, people may experience side effects that have not been previously identified. 

• No guarantee of effect. Study participants may not experience any real improvement — in some cases, the study may show that the drug does not work better than the existing standard. 

• Treatment regimen may change. Participation in the study may mean that you will be given either a new drug or a control group, and there may be regular examinations and additional burdens.

• Refusals or additional procedures. Participants may be offered additional tests, visits, and possibly restrictions (e.g., on other medications or procedures).

• Impact on current treatment. It is important to discuss participation with your doctor to ensure that it does not interfere with or conflict with your basic treatment.

• Withdrawal from the study. If you decide not to continue, how will this affect your further treatment, your access to the drug, and are there any alternatives?