Banner Health
Making healthcare easier

Clinical Trials FAQs

Clinical trials are necessary for advancing health care. They help researchers discover and develop new methods to prevent, treat and even cure life-threatening diseases, chronic illnesses and other health-related conditions. And clinical trial volunteers are a critical component of this important work.

People volunteer to participate in a clinical trial for several reasons. From seeking treatment where one currently does not exist, to gaining access to promising new treatment methods and expert clinical care, to simply the desire to be a part of the research that is advancing knowledge in an area of interest or personal meaning - joining a clinical study is a personal choice that benefits everyone.

What Kind of Clinical Trials Are There?

There are clinical trials for every medical condition—including life-threatening diseases such as cancer, Alzheimer’s disease or AIDS, chronic conditions such as acne, allergies or hair loss, and psychological illnesses such as depression or anxiety. Additionally, clinical trials are conducted in phases and each phase is considered a separate trial that builds on the previous one and is conducted to answer its own specific questions.

Are Clinical Trials Safe?

Yes. Before a clinical trial is started, the U.S. Food and Drug Administration (FDA) requires pharmaceutical researchers to conduct years of safety testing on the new treatment. All clinical trials must also be approved and monitored by an Institutional Review Board (IRB), 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.

Can Healthy Volunteers Participate in Clinical Trials?

Yes. Healthy volunteers can participate in clinical trials, even if they aren’t diagnosed with an illness or don’t have any known significant health problems. Healthy volunteers play an essential role in medical research, as they can help define what “normal” looks like when developing and testing new treatments. In clinical trials, healthy volunteers serve as controls and are given the same treatment as patients that share similar characteristics. The test results are then compared between the healthy volunteers and the patient groups. 

Healthy volunteers can also participate in observational studies, which are intended to provide more knowledge about populations, diseases, beliefs or behavior by tracking health outcomes over time. Observational studies don’t include any treatment and generally require less participation time. 

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. Anyone who meets the eligibility requirements for a clinical trial may apply for the trial.

At What Point During My Treatment Can I Join A Clinical Trial?

Clinical trials are offered to you at any time after receiving your diagnosis. To receive the greatest access to cutting-edge treatments, we encourage you to join a clinical trial early on. Before joining a clinical trial, ensure you understand what to expect and the questions you should ask.

Can Children Participate In Clinical Trials?

Yes. Children are considered a unique population with specific developmental and physiological differences from adults. Involving children in clinical trials is essential for discovering and improving age-specific, evidence-based treatments and therapies. Since children’s bodies work differently, it’s critical to develop treatments specifically for children versus modifying adult doses and treatments. Researchers usually have specific requirements when enrolling children in a clinical trial. If you are interested in enrolling your child in a clinical trial, reach out to your child’s health care team.

Can Caregivers Enroll Their Loved One with Alzheimer’s In a Clinical Trial?

Yes. In addition to the informed consent, research studies that involve participants with Alzheimer’s disease or related dementias also include what’s called an “assent process.” This enables a caregiver or another legally authorized representative to enter a participant into a clinical trial. The staff at the research institute will, to the greatest extent possible, confirm with the person with Alzheimer’s or dementia his or her desire to participate. However, given the vulnerability of this population, it’s critical that you, as the caregiver, understand the requirements and be willing to assist in fulfilling the study responsibilities with the person for whom you care.

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 trial 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 Institutes 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?

Banner Research, 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 participants. If you choose to volunteer for a clinical trial on a Banner Health campus and have any questions or concerns, please contact us.

What Are Caregiver Responsibilities During a Clinical Trial?

When your loved one participates in a clinical trial, you may take on several responsibilities for them, including:

  1. Making sure they attend all appointments
  2. Ensuring all diary/journal information for the clinical trial is entered and current
  3. Helping identify and communicate adverse effects from the treatment
  4. Monitoring and ensuring your loved one is taking the treatment properly and on schedule
  5. Attending trial visit appointments and taking detailed notes so your loved one understands the process. Ask the research team any questions  as needed
  6. Keeping files and documents organized so your loved one can easily find a document if needed
  7. Offering emotional support

The research staff and trial sponsors appreciate the hard work of caregivers and may offer compensation programs and travel reimbursement.

Do I Need to Pay to Be In a Clinical Trial?

Every clinical trial is different. Usually, the participant or their insurance company is asked to pay for routine tests, treatments or procedures that would normally be a part of their standard care. The trial’s sponsor generally pays for any costs related to the study, including any special testing that needs to be conducted and additional out-of-pocket expenses for treatments related to the study. The informed consent will disclose the costs that the participant is expected to pay and those that the trial sponsor will pay.

How Long Will The Trial Last?

The duration of a clinical trial depends on several factors, including the illness being treated, the treatment being tested and the clinical phase the participant is placed in.

A treatment for a short-lived infection, such as an antibiotic, will typically take a shorter time to test and conclude. On the other hand, a treatment for a chronic disease may require that participants’ progress is tracked over a longer period of time.

What Are The Chances I’ll Receive a Placebo?

A placebo pill is most commonly used when a standard treatment is available and the research team wants to compare the treatment being tested against the standard treatment combined with a placebo. A placebo does not provide any health benefits. Placebos are only given for clinical trials when it’s safe and medically appropriate. If a placebo is given for a clinical trial you are considering, you will be informed before the trial begins. 

Can I Quit The Trial?

Yes. As a volunteer, you have the right to quit the clinical trial at any time, for any reason. Before quitting a trial, we recommend first talking to your doctor to learn how quitting may affect your health and if there are other treatment options available. If you decide to quit the trial, the principal investigator will ensure you are safely removed.

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 who 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 treatment 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 treatment is working, if it is safe and whether it has any side effects. FDA medical advisors and specialists closely review this data before approving any new treatment.

Even after a new treatment is approved, pharmaceutical companies will continue to conduct studies to compare the safety, effectiveness and cost of the new treatment to other treatments already on the market. Other research studies may determine if a treatment can be administered to children or special populations. Some studies assess a treatment’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 treatments 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.