What does a typical clinical study look like?
Clinical studies help determine whether new treatments are safe and effective. And research participants make it all possible. Participants may receive specific interventions — which may be investigational medications, devices, or procedures — according to a research plan (referred to as a protocol) developed by the scientists and doctors involved in the studies. Clinical studies may compare a new medical approach to a standard one that is already available, to a placebo that contains no active investigational medication, or to no intervention at all. These elements vary depending on the clinical study, and the study team will discuss these in detail before you agree to participate. With participant safety in mind, governing bodies have established many rules to help ensure that research studies are conducted in the most ethical and safe way possible to keep participants protected throughout.
How long is a clinical study?
The duration of a clinical study will vary depending on the protocol. Clinical studies are designed by a team of expert scientists, physicians, and statisticians. When you learn about a study, you will be informed about the time commitment needed before you consent to participate.
Will taking part in a clinical study cost me anything?
There is no cost to participate, and some research studies offer reimbursement for your time and effort. This will vary depending on the research study and is discussed during the informed consent process.
What if I want to leave a clinicalh study?
You can leave a clinical study at any time and for any reason. You are under no obligation to complete a clinical study or give a reason why you’re leaving one. Although we do our best to make our research studies as easy as possible for you to take part in, we understand that there are many reasons why finishing may not be possible.
What happens after I complete the clinical study?
After you complete the clinical study, the study team will answer any questions you may have and get your feedback on your overall experience during the trial. After the study, participants should continue to see your local primary doctor or healthcare provider for routine medical care.
Can I talk to other people about the clinical study?
We understand that talking about your experience is an important part of feeling supported. You may speak with your family, friends, or doctor about your potential participation in the clinical study. We also have a talented team of doctors, researchers, and coordinators who are happy to address your questions and concerns.
What about my primary doctor? Can I tell to my doctor? Will my doctor get involved?
You can always share information about the clinical study with your primary care doctor or other healthcare provider, such as a specialist. We encourage you to do so, especially if this is someone you know well and trust. Your doctor can be an additional resource when you are first learning about a study and have many questions. You can continue to see your doctor throughout the clinical study for routine visits and tests. Our research study team is available to talk to both you and your doctor if there are any concerns or questions. Working together helps to ensure that you are fully supported for your health needs.
Will my normal healthcare be affected?
No, your normal healthcare will not be affected by taking part in a clinical study. During the study, you can continue to visit your doctor for any health issues not related to your participation in the study. We will keep your doctor informed about your participation, the parameters of the trial and its impact on your condition. On leaving the trial your usual healthcare will not be affected, as your doctor will care for you exactly as they did before the clinical study.
How are clinical studies regulated?
All clinical studies are regulated by approved governing bodies, to ensure the health and wellbeing of all patients participating. A clinical study can only be offered to our study patients once it’s been approved by EMA, FDA and the local pharmaceutics institute (HU: National Institute of Pharmacy and Nutrition – OGYÉI) and with supportive opinion of local research ethics committee (HU: Medical Research Council Committee of Clinical Pharmacology and Research Ethics – ETT KFEB) whose job it is to ensure the rights, dignity and wellbeing of all trial patients, are not being compromised.