What is a clinical trial?

Cancer clinical trials are conducted with the goal of improving the way we prevent, diagnose or treat cancer. Clinical trials are used to carefully examine if a certain drug or procedure is safe and effective, which can lead to its approval, resulting in better care and outcome for patients. Virtually all of today’s FDA-approved cancer treatments were investigated in a clinical trial.

Are there other options if I do not match with a clinical trial?

Yes, through expanded access or “compassionate use”. This is the use of new, unapproved drugs to treat those who do not necessarily meet clinical trial criteria for patients with life-threatening, or serious conditions. Access might be appropriate given the following conditions by the FDA: Patient has serious disease/condition, or whose life is threatened by disease/condition No comparable alternative treatments available for the disease or condition Clinical trial enrollment is not possible Potential benefit outweighs the risks of treatment Investigational medical product will not interfere with investigational trial, and further support medical products development You can find additional information related to Expanded Access in the USA here. You can find additional information related to the Special Access Programme in Canada here:

Are clinical trials free for everybody?

Generally, participation in a clinical trial is free, however, there can be costs associated with clinical trials, such as patient care costs that are not covered by trial sponsors (e.g. pharma companies that run trials). The National Cancer Institute explains in depth below: Patient Care Costs: These are general costs related to treating your cancer. While these costs can be covered by trial sponsors (e.g pharma company), this is not always the case. This is dependent on specific trials and companies. It is important to note that patient care costs can often be covered by your health insurance. Patient care costs can include the following: Doctor visits Hospital stays Standard cancer treatments Treatments to reduce or eliminate symptoms of side effects from treatment Lab tests X-rays/Imaging tests Research Costs: These are costs associated with taking part in the trial itself (e.g, cost of the experimental drug). Trial sponsors (e.g., pharmaceutical companies) often cover these expenses. Research costs can include the following: Study Drug or procedure Lab Tests for research purposes (e.g. a biopsy) What happens if I do not have health insurance? This is on a per-trial basis, where some trial sites will accept patients without insurance (self-pay patients), while others do not. If you’re interested in applying to a specific trial, please let your clinical trial specialist know and they will inquire with the trial site on their specific insurance policies. If you do not have medical insurance, there are nonprofits available that help cover costs associated with cancer treatment. You can find a list of these non-profits by going to our Patient Support Resources.

What are the possible benefits of participating in a trial?

According to the National Institute of Health, the following are potential benefits: You may receive a new treatment for a disease before it is available to the public You can play a more active role in your own health care Researchers might be able to provide you with medical care and more frequent health check-ups as part of your treatment You can have the chance to help others receive better treatment for their health problems in the future. According to the National Comprehensive Cancer Network Guidelines, patients enrolled in clinical trials receive the best management of care. A Penn State Cancer Institute 2020 study of 12 million cancer patients found that those enrolled in clinical trials live longer. What are the possible risks in participating in clinical trials? According to the National Institute of Health, the following are potential risks: New treatments might cause side effects New treatments might not work better than the standard treatment. You may NOT be part of the treatment group (or experimental group) that gets the new treatment

How often/long are the trials? Am I able to withdraw?

It depends on the trial and the procedure. It also depends on your response to the treatment. As long as you clinically benefit from the treatment with no or manageable side effects, you will continue to participate.

What are the four phases of clinical trials?

Phase 1: Experimental testing is performed on a small group of “healthy” individuals to judge the safety and side effects to find a correct dosage.
Phase 2: Effectiveness of the trial is tested on a larger group of individuals during this phase. Its main goal is to retrieve preliminary data on whether the drug works in people who have a certain disease/condition. This phase can last several years.
Phase 3: More information is obtained about safety and effectiveness, studying different populations and dosages, while also combining with other drugs. There is a larger subject group, and if the FDA agrees that trial results are positive, the experimental drug or device will be approved.
Phase 4: This takes place after the FDA has approved their use. The device or drug is closely monitored in large and diverse populations. Sometimes the true effects of a drug might not be clear until more people have taken it over a long period of time.

Can I withdraw in the middle of a trial?

You have the right to leave at any point during a trial, however, we strongly recommend that you consult with your doctor first, as there could be side effects.

What is a trial drug?

This is a drug that is administered in order to test, diagnose, and prevent current cancer.

What is a placebo drug?

A placebo (often called a sugar pill) is an agent that has no effect on the disease or patient, and is used in some clinical trials as a control to measure the success rate of the new medication. Today many studies use the current standard of care as a control. This means that patients will be administered either the conventionally available treatment or the new experimental treatment. There are a few different structures that a trial can take: Open label clinical trial: Both clinicians and patients know which treatment is being administered Double blind clinical trial: Neither clinicians nor patients know which treatment is being administered. However, it’s important to note that even in blind trials patients are almost always offered, at a minimum, the current standard of care, meaning that you will receive treatment while enrolled in a trial. Note: In trials where this is not the case (i.e., patients are not getting the standard treatment), the trial coordinator and investigator will disclose all necessary information to the participant. Standard of care: patients will receive the most up-to-date treatment available.

What happens if I get a placebo?

The FDA has made a commitment to ensure that patients with serious conditions undergoing clinical trials will not go untreated, or receive placebo unless administered under certain circumstances. Further, the FDA has urged the drug development industry to avoid using placebo if there are other treatment options available that could save patients lives. It is important to note that during clinical trials, patients are usually not given zero treatment, and are instead divided into two groups.

Control group: receives the standard-of-care treatment. The standard of care treatment is usually the most commonly used existing treatments available. Overall, the most common placebo drugs administered are standard of care (approved therapy for your stage of cancer), verus the same therapy used in conjunction with the new experimental therapy.

Is there eligibility criteria for clinical trials?

Yes, each clinical trial has different eligibility criteria…but this is our job! We use your personal medical profile to match you with clinical trials that you are eligible for.

Do I need to be an American citizen to participate in clinical trials in the U.S?

This is dependent on the specific clinical trial. If a clinical trial is recruiting international patients then a visa will be necessary, please read below steps necessary to participate in clinical trials based in the U.S.

Will I need a visa, and if so, what type?

Yes, a B-2 visa is required

Where and how can I apply for a B-2 visa?

You can apply for a B-2 visa at your local embassy/consulate

What will I need to apply for a B-2 Visa for U.S. medical treatment?

You must prove that a clinical trial is “necessary,” and that it is unavailable in your home country. Please click on this link to learn more about what is needed to enroll in a trial in the U.S.

Will I need letters from my physician?

We currently match patients to clinical trials in the United States, Canada, and Israel. We will be expanding to other countries in the near future.

Is Leal HIPAA Compliant?

Leal meets all the security measures of HIPAA requirements. We have strict security management with all patients’ medical information and only work with software that is HIPAA compliant.