Welcome to our Clinical Trials Page!Here we hope to educate readers about the world of Clinical Trials. Read an overview below about how Clinical Trials work, or to learn more about specific studies that you or a loved one could participate in by Joining AlzU.org Today!
What Are Clinical Research Trials?Clinical research - also referred to as clinical research trials, are conducted in order for medical researchers to decipher just which therapies or interventions are the most effective and safe to detect, treat or prevent a disease such as Alzheimer’s disease (AD). Not only do clinical trials look at the effectiveness and risks of specific treatment interventions or drugs, researchers also evaluate other aspects of medical care, such as how to improve the quality of life for people with chronic illness such as AD.
Before a new drug or treatment can be used to treat a disease, it must first be carefully tested in a laboratory, then with live people, in what is called a clinical research trial, in order to evaluate the effectiveness and safety of the drug or treatment.
There is a protocol that is followed for every clinical trial, designed to answer a specific research question, as well as protecting the safety of the participants in the study. A protocol describes exactly who will participate in the trial, which tests and procedures, medications and dosages will be used, as well as how long the study will last, and what type of information will be collected during the study.
The federal government mandates that all clinical trials are governed closely by an Institutional Review Board (IRB) - comprised of a committee of physicians, statisticians and members of the community. The IRB is appointed in order to ensure the risks of the clinical trial are minimal and that potential benefits are worth the risks.
What if I don’t want to take an Experimental Drug, but I do want to Help Advance Alzheimer’s research?
There are a variety of research studies that aim to assess the effectiveness of things other than drugs, like exercise, dietary changes, or even educational strategies (which is why www.AlzU.org was created).
Taking part in a research study does not have to mean that a person needs to take an experimental “drug”, specifically.
Phases of a Clinical Trial
There are several different phases of a clinical trial, each developed in order to help researchers answer different questions. Phases include:
Phase I - an experimental drug or treatment is tested in a small group of between approximately 20 and 80 participants to test a drug or treatment’s safety and identify any side effects
Phase II - an experimental drug or treatment is tested in a larger group of approximately 100 to 300 participants in order to continue to evaluate its safety
Phase III - an experimental drug or treatment is given to a very large group of (on average) approximately 1,000 to 3,000 participants (could be more or less) in order to compare it with standard treatment and gather information on side effects and safety
Phase IV - after the drug has been FDA approved, studies continue in order to track of its long term safety and effectiveness as well as its optimal use
What is a Double Blind Placebo Study?In a single blind placebo study, participants are NOT aware of whether they receive the real drug being tested or a placebo (“sugar” pill with no therapeutic effect whatsoever). This study reinforces the fact that participants are not subject to being influenced in any way by how they anticipate the reaction to the experimental drug to be. In a single blind study, only the participant is NOT told whether she/he is taking a drug or a placebo. A double blind study involves none of the members of the research team (including the participants) being told which group is getting the investigatory drug or which group will get the placebo.
The Good News Regarding Clinical Trials!
Those who have been newly diagnosed with AD and their caregivers and family members may be very interested to know that there are some great benefits to becoming involved in local research trials. You can learn more by joining AlzU.org, or there are also informative websites designed in order to help participants locate new clinical trials, such as TrialMatch (sponsored by the Alzheimer’s Association), and www.ClinicalTrials.gov. These websites allow users to search according to the disease entity being studied, age group of participants, and geographic area.
Benefits of Becoming Involved in Clinical Trials
- Participants get to take an active role in their plan of care
- Individuals involved in clinical trials contribute to helping others
- Many clinical trial participants receive free medical care by experts in their respective field of medicine
- Those involved in clinical research receive the latest in medical advances before they are available to the general public
- Participants may be able to continue treatment/medication even after the clinical trial is over
- Those with chronic untreatable illnesses gain hope for a brighter future or perhaps even a cure for the disease
- Clinical trials can provide a positive milieu in which participants can seek the support of others going through the same experiences regarding their disease