Volunteering for a Clinical Trial
- What is a clinical trial?
- Should I join a trial?
- What kind of clinical trials are there?
- How do I know a trial is safe?
- What is informed consent?
- Who runs clinical trials?
- What role does Banner Research play in this process?
- Am I eligible?
- What happens after a clinical trial?
- How to participate in a research study at Banner Health
- Clinical trials conducted at Banner Health
What is a clinical trial?
A clinical trial is a study that is used to find information about new medicines. Information gathered during clinical trials can help pharmaceutical researchers to develop new and better medicines for life-threatening diseases, such as cancer or Alzheimer's disease, and more minor ailments such as hair loss or the common cold. Without clinical trials, we would not have many of the medications and vaccines that we use every day to protect our health.
Should I join a trial?
As a volunteer in a clinical trial, you help in the development of medical therapies—therapies that may offer better treatments and even cures for life-threatening and chronic diseases. People volunteer to participate in a clinical trial for a number of reasons. You may get involved in a trial because you simply want to help in the advancement of science. Or you may be suffering from a disease for which a good treatment does not exist presently. You may join a clinical trial hoping to get improved medical care. Or you may not have health insurance and clinical trials are a way to get study-related medical care.
What kind of clinical trials are there?
There are clinical trials for every medical condition—including life threatening diseases such as cancer or AIDS, chronic conditions such as acne, allergies or hair loss, and psychological illnesses such as depression or anxiety.
Clinical trials are generally divided into four phases:
Phase I trials are designed to confirm the safety of a new medication. Phase I trials generally involve a small group of healthy volunteers and typically last three to four months.
Phase II trials help to confirm whether or not a medication is effective. These studies are “randomized”. Randomization means that participants are divided into two groups—one group receives the active treatment and the other group receives a “control”. (Usually the standard treatment available).
Phase III trials are initiated once a treatment has demonstrated both safety and efficacy. Phase III trials help determine whether a medication is effective over a longer period of time. These trials are longer and larger, in terms of the number of participants. Phase III trials can provide enough data for a product to be submitted for approval by the Food and Drug Administration (FDA).
Phase IV clinical trials are conducted to obtain more information on a new medicine that has been submitted to the FDA for approval. Phase IV trials are also conducted when a company is gathering more information about a product already on the market.
How do I know a trial is safe?
Before a clinical trial is started, the United States Government requires pharmaceutical researchers to conduct years of safety testing on a new product. All clinical trials must also be approved and monitored by an institutional review board (IRB), which is a special committee of independent physicians, medical experts, and lay people. The IRB reviews the design of the study and the progress of the trial to make sure that patients are not exposed to unnecessary risks.
How do I know if I am eligible to participate?
All clinical trials have specific eligibility requirements, which are outlined by the pharmaceutical company and the FDA. Anyone who meets the eligibility requirements for a clinical trial may apply for the trial.
What is informed consent?
If you qualify for a clinical trial, you will usually be asked to sign an informed consent form. This form contains important information about your trial, such as what will be asked of you during the trials and why the research is being done. Informed consent also gives you the right to withdraw from the trial at any time.
Who runs clinical trials?
In most cases, clinical trials are sponsored either by the federal government, through the National Institute of Health (NIH), or by pharmaceutical companies. The physicians and health care professionals who actually run the daily operations of a clinical trial are known as “trial investigators”. These professionals are chosen because of their medical expertise in a specific therapeutic area.
What role does Banner Research play in this process?
Research Administration,a corporate division of Banner Health, exists to ensure research is conducted ethically, safely and efficiently. Banner Research maintains oversight of any and all clinical trials performed at a Banner Health facility. Such oversight includes review and approval by the Banner Institutional Review Board to ensure the protection and safety of clinical trials for volunteers. If you choose to volunteer for a clinical trial on a Banner Health campus and should have any questions or concerns, please contact our offices directly at (602) 747-9700.
What happens after a clinical trial?
When a clinical trial ends, several things might happen. For a serious illness, a pharmaceutical company might continue to provide study medication to those patients that are responding well. On some occasions, a patient will stop receiving the investigational treatment. In this case, a patient may have to wait for the drug to become available to the public. After a study is complete, all of the information is collected and analyzed. This information determines whether a study drug is working, whether it is safe and whether it has any side effects. FDA medical advisors and specialists closely review this data before approving any new drug.
Even after a new drug is approved, pharmaceutical companies will continue to conduct studies to compare the new drug—in terms of safety, effectiveness and cost-to other drugs already on the market. Other research studies may determine if a therapy can be administered to children or special populations. Some studies assess a drug’s long-term effectiveness and its impact on the quality of a person’s life.
Every volunteer in a clinical trial is extremely valuable and important. Without volunteers, there would be no new drugs to fight diseases and ailments. By participating in a clinical trial, you are helping yourself and others like you live longer and healthier lives now and long into the future.