Why should I join a trial?
There are many reasons individuals may choose to join a clinical trial, including a desire to take part in the advancement of science, receive access to treatments and therapies not currently available to the general public or because they have not benefited from other traditional therapies.
What about safety?
Before a new treatment is tested in participants, it is carefully studied for several years in laboratories and evaluated for safety. Before a trial is approved at a specific site, it must also be approved and monitored by an Institutional Review Board. This ethical committee reviews research studies and related activities to ensure the rights and welfare of participants are protected.
What is informed consent?
If you participate in a clinical trial, you will be asked to review and sign an informed consent form and patient privacy forms. This document contains important information about your trial, including what will be asked of you during the trial and why the research is being done. Informed consent lets you know that participation is voluntary and also gives you the right to withdraw from the trial at any time.
Clinical trials involving participants with Alzheimer's disease and other dementias also include an assent process, which enables the caregiver or other legally authorized representative to enter a participant into a trial. The research institution will, to the greatest extent possible, confirm with the patient that it is his or her desire to participate. However, given the vulnerability of this population, it is critical that the caregiver understand the requirements and be willing to assist in fulfilling the patient's study responsibilities.
Who runs clinical trials?
In most cases, clinical trials are sponsored either by the federal government, through the National Institute of Health, or by pharmaceutical companies. The physicians and health care professionals who run the daily operations of a clinical trial are known as "trial investigators." They are chosen for their medical expertise in a specific therapeutic area.
What role does Banner Research play in this process?
Banner Research, a corporate division of Banner Health, exists to ensure research is conducted ethically, safely and efficiently. Research activities conducted at a Banner facility, including Banner Alzheimer's Institute (BAI), are overseen by an Institutional Review Board.
How do I know if I am eligible to participate?
All clinical trials have specific eligibility requirements, which are outlined by the pharmaceutical company, the U.S. Food and Drug Administration (FDA) and the agency or institution leading the trial. Those who meet the eligibility requirements for a clinical trial may apply.
What happens after a clinical trial?
When a clinical trial ends, several things may happen. In some cases, a pharmaceutical company will continue to provide study medication to those patients who are responding well. In other cases, patients will stop receiving the investigational treatment and have to wait until the drug becomes available to the public. After a study is completed, all of the information is collected and analyzed. Study data is used to determine the efficacy, safety and side effects of the study drug. FDA medical advisors and specialists closely review this information before approving any new drug.
Even after a new drug is approved, pharmaceutical companies continue to conduct studies to compare the safety, efficacy and cost of the new drug with others already on the market. Additional research studies may determine if a therapy can be administered to children or special populations. Some studies assess the long-term effects of a drug and its impact on a person's quality of life.
Every volunteer in a clinical trial is extremely valuable and important. Without volunteers, there would not be new drugs, treatments and therapies to fight illnesses and diseases. By participating in a clinical trial, you are helping yourself and others like you live longer, healthier lives now and for generations to come.