frequently asked questions
Clinical Trial Basics
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.
Yes, “compassionate drug use”, which 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 (FDA):
- A patient has a serious disease/condition, or whose life is threatened by disease/condition
- No comparable alternative treatments are available for the disease or condition
- Clinical trial enrollment is not possible
- The potential benefit outweighs the risks of treatment
- The investigational medical product will not interfere with the investigational trial
Clinical Trial Costs
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)
Each clinical trial is different. Some trials accept patients without insurance (self-pay patients), while others do not.
If you do not have medical insurance, there are nonprofits available that help cover costs associated with cancer treatment. Please email us at firstname.lastname@example.org or use the Support icon if you would like to learn more about nonprofits that assist with medical costs.
Benefits and risks of being involved 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.
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.
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.
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.
Trial drug versus placebo drug
This is a drug that is administered in order to test, diagnose, and prevent current cancer.
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.
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.
- New experimental drug
- 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.
Eligibility for 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.
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. In order to do this you will need to provide the following:
- Traveling to the U.S. for the purpose to receive medical attention
- Length of stay is temporary (along with specified time)-this can be obtained from your treating physician
- Proof of permanent residence outside the U.S., as well as other binding ties (family, job, etc.) to demonstrate that you have intentions to return to your home country
- Valid, unexpired passport
- DS-160 form confirmation page
- Receipt of visa fee
- Copy of appointment letter
- Letter from employer
- Finances to pay for travel (Must provide bank statement or other records to show that you have the money readily available to pay for your medical care)
- If you do not have the funds, please have a close friend or family provide a Form 1-134, Affidavit of Support, where you can find the form here: https://www.uscis.gov/i-134
**Important note: When you visit the U.S. consulate you are given a short amount of time to request your visa, coming prepared with the above documents/ proof will support your request.
- Yes, you will need letters from both your physician, as well as the treating physician in the U.S.
- Nature of illness
- Diagnoses & recommended treatment
- Reason why treatment is available in your home country
- Your doctors recommendation that you seek medical care in the U.S
If you have further questions or clarification, please read this helpful article for B-2 visas for U.S. medical treatment.