What are clinical research studies?
Clinical research studies are conducted to determine whether an investigational drug is safe and effective in treating a particular disease or condition. They also check for any unexpected or undesirable health changes that may develop while taking the drug.
Clinical research studies are performed according to strict governmental and ethical guidelines. These guidelines help ensure that patients’ rights are protected in the study while valuable information about the investigational drug is collected. Once a clinical research study is completed, government agencies review the information and decide whether the investigational drug should be made available for public use.
What are the phases of clinical research studies?
An investigational drug must pass 3 phases of clinical testing before it is approved by a country’s regulatory authority and made available to the public.
- Phase 1 – The investigational drug is given to a small group of healthy volunteers. Researchers look to see how much is safe to take and how the human body responds when it receives the drug.
- Phase 2 – The investigational drug is given to a small group of people with the target condition, or condition it is intended to treat. During this phase, researchers evaluate what dose is appropriate and begin to test the safety and efficacy of the drug.
- Phase 3 – Researchers test the safety and efficacy of the investigational drug in a larger group of participants over a longer period of time. Sometimes comparisons are made between the investigational drug and other medications that are already approved for the same purpose.
The SPI2 Study is in Phase 3.
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 participating in a clinical research study?
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?
- Investigational drugs
By participating in a clinical research study you can gain access to investigational drugs that would otherwise be unavailable, play a more active role in your own healthcare, and contribute to medical research that may help other people with MS in the future.
- Medical care
You will receive close attention from the study staff while on the study. You will be provided with information about your health through regular physical examinations and medical tests. Extensive health check-ups may help to uncover undiagnosed medical conditions.
- Flexible participation
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 treatment as you did before joining. A study doctor will discuss alternative treatment options that may be available to you.
- MD1003 guaranteed
During the extension period, no placebo will be taken so all participants will have the opportunity to receive the investigational drug, MD1003.