What are clinical research studies?
Clinical research studies are designed to test the safety and effectiveness of investigational study medications. Government agencies require that before any medication can be prescribed to the general public, it must go through multiple phases of research.
All clinical research studies follow strict government guidelines to help ensure that the rights and health of participants are observed during the study while allowing researchers to collect valuable information about the investigational study medication.
What are the phases of clinical research studies?
Before any investigational study medication can be approved for use in the general public, it must go through three phases of clinical research.
The investigational study medication is given to a small group of healthy volunteers. Researchers consider the dosage of the investigational study medication that can be safely given and monitor how the human body reacts.
The investigational study medication is given to a small group of people with the disease or disorder being studied. In this phase, researchers are investigating what dose is appropriate and to start testing the safety and effectiveness of the investigational study medication by comparing it to a placebo (a tablet that has no active drug in it).
Researchers test the safety and effectiveness of the investigational study medication in a larger group of participants. Sometimes comparisons are made between the investigational study medication and another medication that is already approved to treat the disease or disorder being studied.
The AMARANTH Study is a Phase II-III clinical research study. This means that the investigational medication will be tested for both safety and effectiveness compared with another regimen (in this instance, a placebo).
Why are clinical research studies conducted?
Clinical research studies are needed to determine whether an investigational study medication is effective and safe. Every new investigational medication must have completed all three phases of clinical research before it can be approved by government agencies for use in the general public
What is informed consent?
Informed consent is the process that allows you to learn the important information about a clinical research study so you can decide if the study is right for you and if you want to take part in the study.
Before participating, we will take you through a written Informed Consent Form (ICF) that has important information to consider before joining the study. The study doctor will go through this document with you and answer any questions you may have.
This document provides details of the study, such as study expectations, duration, and what you will need to do. All known possible risks and potential benefits are also explained in the ICF. After you have read and discussed all of the information about the study, you can decide whether or not to sign the consent form and participate in the study. You are always free to leave the study at any time and for any reason, with no penalty to you.
Additionally, during your participation, the study doctor will let you know in a timely manner of any new information that may change your mind about participating.
What to consider before participating in a clinical research study?
Participation in a clinical research study is associated with some risks. Some of these risks are known, some may not yet be known. The investigational study medication may possibly cause side effects and may have limited or no medical benefit.
Participation in a clinical research study is an important decision and should be carefully thought out. You should never feel obligated to participate in a clinical research study. Even if you join the study, you can quit at any time for any reason. If you decide to quit, you will receive the same standard of treatment as you did before joining the study, however, you will not be able to continue taking the investigational study medication. A study doctor will discuss other treatment options that may be available to you.
Why should I join a clinical research study?
Taking part in a clinical study is a big decision and needs to be thought through carefully. Many people do take part in clinical trials for different reasons.
Access to new investigational study drugs
By participating in a clinical research study you can gain access to new investigational drugs that would otherwise be unavailable, and have an opportunity to contribute to medical research that may help people in the future.
Study-related free 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 future treatments in early Alzheimer’s disease.
Remember there is no guarantee that you will benefit by participating in this clinical research study, and if you choose to participate, you are free to quit at any time for any reason. If you do decide to quit, you will receive the same standard of treatment as you did before joining the study, however, you will not be able to continue taking the investigational study medication. A study doctor will discuss other treatment options that may be available to you.