Clinical trials are the new and one of the most widely used treatments for cancer patients. This scientific research involves people surviving from cancer and provides them a ray of hope to prevent cancer. Clinical trial treatment has multiple stages where the experts thoroughly study the entire background of an individual before giving them a new intervention. Once the studies on the patient show promising results, they are moved to a clinical trial.

As confusing and jargon-ish as this sounds, clinical trials are nothing but a modern way to evaluate new and refined methods of preventing, detecting, diagnosing, treating, and curing cancer. For a layman and even for a cancer patient understanding what exactly is a clinical trial can be challenging. Therefore, to help you out with the same, we have created this FAQ section. Keep reading and know what exactly to expect in the treatment, benefits, and cost associated.

Why are clinical trial treatments important?

Most cancer treatments today are nothing but the extension of a clinical trial. Moreover, due to the progress made in the arenas of this scientific research, it promises a long life for people living with cancer with guaranteed remission from the disease. Hence, if you want to gain promising results and new interventions, participate in a clinical trial.

What type of clinical trials are available?

There are many stages and trials of clinical trials, for example:

• Prevention: Not just remission, clinical trials, and research aim to find new ways to eliminate the chances of cancer.
• Screening: Regular screenings are the sole variants for people who have high chances of cancer mutation. Clinical trials try and test new ways of detecting cancer at an early stage and treating the same.
• Diagnostic: Clinical trial researchers are on a voyage to study new procedures that assist people in identifying and diagnosing cancer at an early stage.
• Treatment: One of the first stages of the trial is treatment tests. Here the specialists thoroughly examine whether or not the new treatment used is yielding good results. The treatments under clinical trials include cancer-killing drugs, surgery, radiation, and vaccines.
• Quality of life/Supportive care: The role of clinical trials doesn’t end on prevention and diagnosis. However, once the person has been diagnosed with cancer, the trial focuses on improving the patients’ lives.

What are different clinical trial phases?

The entire exercise of the Clinical trial is conducted in different phases. Here each phase has been designed specifically to answer scientific questions regarding the treatment:

Phase 1

Phase one of the clinical trial is primarily conducted to find the best dosage from the new intervention with the least side effects. The low medication dosage is given to a small section of people who are then watched very closely by the medical team.

If the group doesn’t show any severe side effects or only minor effects, the doctor increases the medication ratio. This process continues until the doctors find an ultimate ratio that works ideally in the treatment and has acceptable side effects. Once the optimal dosage and medicine schedule are found, the trial moves to its second phase.

Phase 2

Phase two of the clinical trial aims to check if the new intervention works and how effective it is. To check that the researchers provide the “optimal dosage” as decided in phase 1 to the participants. If the interventions appear to help, the researchers move the study to phase 3.

Phase 3

The prime purpose of the phase three trial is to check/ compare if the new intervention is more fruitful than the cancer care treatment already in practice. In phase 3, the participants are either provided the drug of the study group (further intervention) or the control group (standard intervention). This is clearly to compare which intervention works best for them. Here the probability for the participants to fall in the study group to the control group is 1:1.

Many a time, while a participant is under clinical trial, neither the doctor nor they themselves know which treatment they are going through. This is called blinded randomization.

What is cancer staging?

Cancer Staging is an extension of clinical trials which describes the extent of cancer adversities depending upon the size of the tumor. It also detects whether or not cancer inside your body can spread to other body parts.

How does cancer staging work?

Suppose a person has been diagnosed with breast cancer. In that case, cancer staging will allow the oncologists to determine whether the gene mutation is bilateral or has affected only one side. Furthermore, based on the staging results, the doctor will plan treatments and suggest the ideal clinical trial for the patient.

What are the risks and benefits of clinical trials?

Forget the prejudice that under a clinical trial, you will be the lab hamster. Understand that every new clinical trial treatment has both benefits and risks associated.

Benefit

We know cancer is a chronic disease whose cure is still unknown. Having said that, we need to understand that in order to gain access to a promising treatment, we need to participate in a clinical trial. Many prejudices and debates surround clinical trials and their benefits, and no one knows the assertive answers. However, we as medical researchers know that clinical trial participation might not always be advantageous. Still, it undeniably will be good and much more beneficial than the current standard of care.

Risks

Clinical trials are a research ground to find new and better treatments for cancer. Therefore, receiving a new treatment as a study participant may:

• Not work or be as beneficial for you as others
• Cause health risks or unknown side effects that may/ may not be as worse as current care treatments
• Hamper personal time as a patient under clinical trials has to visit the clinic and undergo a variety of tests

Is clinical trial safe?

Clinical trials around the globe and especially in the USA, aim to provide patients with one of the safest and effective treatments. Researchers study the entire history of the patients before allowing them to become a part of any clinical trial. And unlike the common understanding of clinical treatments, the researchers don’t mindlessly test every known unknown drug on the patients. In fact, every patient undergoing a clinical trial is given:

• The best treatments available, or
• A new and much more helpful treatment.

Furthermore, every patient that participates in a clinical trial stays under close supervision of the doctor or the medical team to detect any and every minute response to the treatment.

Consent process

If you are paranoid about the safety of your loved one, ensure that before participating, you get a legal document or consent form. Read and examine the consent form thoroughly and study the purpose, possible risks, and benefits.

To ensure peace of mind to the patients at the university cancer center, we have added a new clause to inform them if the treatment poses any new risk or side effect. After the information is circulated, it is up to them to decide whether or not they wish to participate in the same.

Not just that, if anyone wishes to leave the clinical trial due to any reason, they are free to walk out without accountability. Safety and success are in our hands. All we need from you is support!

Oversight

Patient undergoing a clinical trial is not only in the hands of the researcher and patient but is also protected by federal and international laws. In addition to the laws protecting safety and privacy, multiple committees approve and monitor every trial to ensure the ultimate protection. These committees hold the right to pull the plug on any clinical trial that deems unsafe immediately.

What is the average cost involved in a clinical trial?

In the entire research span, there are multiple types of expenses incurred. A few of those include:

• Routine care costs: Routine costs usually comprise visitation charges. You will incur this cost whether or not you participate in a clinical trial. Health insurance usually covers the cost of routine care, though be careful about any co-payments.
• Research costs: The patient does not pay any research costs.
• Additional charges: Apart from routine care costs, the patients might incur travel expenses. Those expenses might or might not be covered by health insurance. At the university cancer center, we provide transportation facilities to anyone in need.

Does insurance cover clinical trial cost?

As per the provisions of federal law, the health insurance plans have to cover the patient’s routine cost. However, you need to ensure that you meet the three necessary conditions, which include:

• Eligibility for the trial
• Trial through an approved center
• No involvement of out-of-network doctors, especially if it is not part of your insurance plan.

Note: If you meet these requirements and wish to join the clinical trial, no health insurance plan can stop you or limit your benefits.

Which costs are not covered?

Almost all costs of clinical trials are covered under health insurance plans. However, there are a few conditions where the health insurance refuses to cover the cost. It includes:

• Health plans such as extra blood tests or scans are done primarily for research purposes.
• Out of network doctors or hospitals.

Note: If your plan has the provision to cover out-of-network doctors or hospitals, you can hold the insurance company accountable to cover these costs.

Glossary

While reading medical blogs, it’s hard to keep up with the jargon used; here is a short glossary for the terminologies we used in the blog.

• Intervention: Intervention refers to new treatments for cancer. These can be anything, even a new drug that might help diagnose, prevent, or screen cancer.
• Dose schedule: A dose schedule refers to how often you are expected to consume the drug. It can be once a day, twice a day, once a week, etc.
• Extent: Extent simply refers to the severity of cancer. The doctors often use the term while diagnosing the tumor in the body.

If you found these FAQ answers helpful and need more information on clinical trials or any cancer-related topic, visit the University Cancer Center. We run clinical trials for every age group. Feel free to navigate to our website and interact with the best oncology researchers today.