Answers To Common Questions About Clinical Trials

Research has contributed to many incredible advancements in medicine. Every available treatment and prescription medication went through clinical trials. They let researchers safely test treatments and medications on patients, discovering the benefits and potential side effects and improving future treatments. These carefully controlled trials ensure participants' safety, and they give patients a chance to access new, exciting advancements in medicine.

Understandably, patients may have several questions about clinical testing before they sign up. Participating in a clinical trial is a personal decision, and it's important you know all the facts beforehand. Misconceptions can prevent patients from partnering with researchers in clinical trials and receiving cutting-edge treatments that could significantly improve their quality of life.

Perhaps you've wondered about participating in a clinical trial. Here is your opportunity to get answers to common questions and see if signing up for a clinical trial is the right step for you.

What are clinical trials?

Clinical trials, also called interventional studies, are research studies that look at the effectiveness of medical treatments. They can test medical devices, protocols, medications, procedures, and even lifestyle changes.

These trials might look at the effectiveness of a new treatment by comparing it to an older treatment or against a placebo. They may also compare current treatments against each other to see which is the most effective in combating or preventing a disease.

The Federal Drug Administration (FDA), an Institutional Review Board (IRB), ethics committees, and the researchers rigorously monitor clinical trials. New treatments undergo extensive testing, ensuring they are as safe as possible before trials begin with participants. There are federal regulations and standards that clinical trials must meet before moving through the phases. If a new treatment passes tests, the FDA can approve it. After that, doctors can prescribe new remedies to patients.

With the help of participants, clinical trials improve medical care options and ensure patients are getting the safest, most effective treatment methods possible.

Why are clinical trials important?

Each clinical trial is an opportunity to improve medical treatments. Researchers can use safety and efficacy information learned in a clinical trial to improve current treatments or develop new ones for widespread use.

It would be much more difficult to test new medical treatments in a safe and controlled environment without clinical trials. These trials allow the medical community to share crucial information on the treatment of cancer, depression, diabetes, and many other conditions.

By gathering this information in a careful, scientific, and regulated way, clinical trials can improve healthcare for patients worldwide.

What are the phases of clinical trials?

New treatments go through extensive testing before they are ready for a clinical trial. This testing ensures they show promise of improving a current treatment method and are safe for participants in the study. When a new treatment is ready for a clinical trial, it will go through several phases of testing, as defined by the FDA:

Phase I

Since this is the first testing phase involving people, the number of participants in a study will be small, usually between 20 and 80 healthy people. This phase looks at the safety of the treatment and any side effects it causes.

Phase II

If the treatment passes Phase I, it goes into Phase II, which tests the new treatment on groups of 100 to 300 people with a specific condition or disease. Researchers continue to monitor the safety of the treatment and any side effects. In Phase II, they are trying to determine if the treatment works against the particular condition.

Phase III

When a treatment reaches Phase III, researchers test on a bigger and more diverse group of participants. Here, they compare the new treatment against an old medication or a placebo. They continue to look at the safety of the treatment and how effective it is in treating a condition or disease. They will check if the new treatment interacts with any other medications or treatments used by the participants.

Researchers might use a double-blind study. This type of study is where neither the researchers nor the participants know who is getting the new or existing treatment. This method allows the researcher to compare the results without bias and see which is the most effective.

Phase IV

The FDA must approve a new treatment before it can move onto this phase. These studies can last a decade or more because Phase IV enlists large groups of participants to determine the long-term effects of the new treatment. Long-term effects may be increased survival rates or rare side effects when used for a long time.

As the new treatment has FDA approval, doctors can prescribe it for their patients. Therefore, you can access Phase IV treatments without being in the clinical trial. 

How long do clinical trials take?

The length of a clinical trial depends on several factors:

• The number of participants

• The results of the research

• The testing required

These factors mean there is no set duration for a clinical trial. According to the FDA¹, Phase I usually takes several months, while Phases II and III take months to years. On average, it takes around four years for a new treatment to go through the first three clinical testing phases before the sponsoring company can apply for FDA approval.

After approval, clinical trials go into Phase IV, which is the longest phase of testing. During this time, researchers look at the long-term effects of treatment, which means this final phase can last for over a decade. Researchers tell participants how long they expect the clinical trial to take.

Who can participate in clinical trials?

There are clinical trials for people of all ages. There are even clinical trials for pediatric participants (21 or younger), which are invaluable for advancing research in areas such as pediatric oncology.

Each clinical trial has its own set of guidelines about who can participate in the study. These guidelines change for different phases of the trial. Researchers set the guidelines to ensure the safety of participants and to protect the integrity of their research.

You can check the eligibility requirements for the trial before you apply. Research sponsors carefully vet all applicants to ensure they meet the criteria. Due to strict guidelines, you may not qualify for a clinical trial; however, this won't prevent you from applying for others.

Should I use a clinical trial as a last resort?

A clinical trial may be a participant's last resort, but this is not true in every case. Some patients turn to clinical trials when other treatments have failed. Opting for a clinical trial can provide new treatment methods that aren't currently available to the public. Clinical trials can be an opportunity to improve quality of life while advancing research to benefit patients with the same condition in the future.

Other patients might choose a clinical trial when they are newly diagnosed with a health concern. They may see it as a way to take control of their medical care and access cutting-edge medical technology. Participants in clinical trials get extensive medical care and monitoring from leading specialists, which can be an appealing reason to sign up for a clinical trial, even with other options available.

Are clinical trials safe?

As with all medical treatments, there are risks associated with clinical trial participation. Researchers use trials to study the effectiveness of the treatment and any potential side effects, which may be unknown at the time of your involvement.

However, clinical trials are heavily regulated and strictly overseen. An Institutional Review Board (IRB) supervises every federally supported clinical study. This panel comprises doctors, researchers, and community members who monitor ethics and safety. They also ensure the study is doing everything possible to mitigate any risks to the participants.

Federal guidelines regulate clinical trials and reduce risk. The FDA also oversees the clinical trial process and routinely meets with researchers to look at the quality of their research. It also ensures researchers are following strict ethics in how they treat participants and their data.

Researchers must get informed consent from all participants. Before you participate, the researchers must give you all the information on the risks and potential benefits of the new treatment. That way, you can decide if you are comfortable with the risks before the trial starts.

As a participant, you are free to stop participating in a clinical trial at any time, for any reason.

As with all medical treatments, there can be issues in a clinical trial. These issues may include adverse reactions to medications or treatments that are not as effective as anticipated. Participants have a team of healthcare professionals and researchers on hand throughout the trial to monitor for harmful effects and take urgent action if needed. Research teams do everything possible to keep participants safe.

Will I get a placebo?

Placebos² are medications or treatments designed to have no effect on the patient. Researchers use placebos to compare a new treatment to the use of no treatment at all and to combat the “placebo effect.”

Not all clinical trials use a placebo. Researchers only use placebos if it's medically safe and appropriate to do so. You'll never get a placebo if it could put your health at risk. If the clinical trial you are in uses placebos, they will inform you of this ahead of time. You won't know if you are taking a placebo or not, and in double-blind studies, neither will the researchers.

Will I get paid to participate in clinical trials?

Participants in clinical trials often receive compensation, but not always. For example, most cancer clinical studies don't pay participants, but many others do. Reimbursement can make participation more appealing and help mitigate any travel expenses or time missed from work.

If there is compensation, the amount will vary from trial to trial. Factors that affect compensation include the estimated time commitment if you need to stay overnight, and the kinds of testing you'll undergo. The trial will detail the compensation amount upfront.

Your insurance company should cover the cost of routine care during the clinical tests, including doctor visits and routine lab tests. The clinical trial sponsor should cover the cost of any testing done for research. You can verify this information with the researchers and your insurance company before the trial begins to avoid unexpected expenses.

Where can I find clinical trials?

There are several resources where you can find clinical trials looking for participants. ClinicalTrials.gov is a database of clinical trials happening worldwide, compiled by the U.S. National Library of Medicine.

HealthMatch makes it easy to find and apply to clinical trials you are eligible for. Just answer a few questions and we will start searching for the right match for you.