What are clinical research studies?
Clinical research studies are conducted to determine whether an investigational medicine works in treating a particular disease. ‘Investigational’ means that the drug has not been approved for a particular clinical use and is still being evaluated in studies. Clinical research studies also check for any unwanted side effects that may develop while taking the investigational medicine.
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 medicine is collected. Once these studies are completed, government agencies review the information then decide whether the investigational medicine should be made available for public use.
What are the phases of clinical research studies?
An investigational medicine must pass three phases of clinical testing before it is approved by a country’s regulatory authority and made available to the public.
Phase 1 – The investigational medicine is given to a small group of healthy volunteers or patients. Researchers look to see how much is safe to take and how the human body responds when it receives the medicine.
Phase 2 – The investigational medicine is given to a small group of people with the target disease or condition it is intended to treat. In this phase, researchers evaluate what dose is appropriate and begin to test how well it works and whether it is associated with any unwanted effects.
Phase 3 – Researchers test how well the investigational medicine works (and whether it is associated with any unwanted effects) in a much larger group of participants and over a longer period of time. Sometimes comparisons are made between the investigational medicine and other medicines that are already approved for the same purpose.
The PROTECT Study is a Phase 3 study.
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?
- Access to potential future therapies
By participating in a clinical research study you will receive investigational medicines that would otherwise be unavailable.
- Advance understanding
By playing a more active role in your own healthcare, you are contributing to medical research that may help other people with T1D in the future.
- Medical care
You will be provided with extensive information about your health through regular physical examinations and medical tests. Numerous health check-ups may help to uncover undiagnosed medical conditions.