Clinical research studies are conducted to determine whether an investigational drug is safe and effective in treating a particular disease. ‘Investigational’ means that the drug has not yet been approved for a particular clinical use and is still being evaluated in studies. Clinical research studies also check for any side effects that may develop while taking the investigational drug.
Clinical research studies are performed according to strict governmental and ethical guidelines. These guidelines help to ensure that patients’ rights are protected while information about the investigational drug is collected. Once these studies are completed, government agencies review the information then decide whether the investigational drug should be made available for public use.
What is informed consent?
Informed consent is the process through which you learn the most important facts about a clinical research study. Before participating, the study team will take you through a written Informed Consent Form (ICF) and answer any questions you may have. This document provides details about the study, what participation entails, and how the clinical information will be used. Potential risks and benefits, as well as your rights and responsibilities, are also explained in the ICF.
After you have read, understood and discussed all of the information about the study, you can decide whether or not to sign the form. The ICF is not a contract and you are always free to leave the study at any time and for any reason, with no penalty to you.
What should I consider before taking part?
Taking part in clinical research requires careful thought. Before you decide whether to participate, make sure that you understand any potential risks involved; these will be explained to you by the study doctor. There is no guarantee that you will benefit from taking part in this study and you should never feel obligated to participate in clinical research.
Why should I join a clinical research study?
Many people take part in clinical research studies for different reasons.
- Access to new investigational drugs: by participating in a clinical research study you may gain access to new investigational drugs that would otherwise be unavailable and contribute to medical research which may help other people in the future.
- Study-related medical care: you will receive study-related care from a clinical research study team composed of doctors, nurses, and other medical professionals who are committed to your well-being and to research that may lead to better future options for the treatment of axial spondyloarthritis.
- Flexible participation: remember there is no guarantee that you will benefit from participating in a clinical research study, and if you choose to participate, you are free to withdraw at any time for any reason. You will have the right to receive the same standard-of-care treatment as you did before joining. A study doctor will discuss other options that may be available to you.