Considering a clinical trial may seem like a daunting prospect, but sometimes it can be the smartest strategy. Here are some basic questions to help you make a good decision.
1. What is a clinical trial?
The search for new and better treatments for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL / SLL) is constantly in progress. To develop new drugs or combinations of drugs to treat CLL / SLL, research is first completed in the laboratory and then moves into clinical testing also known as a clinical trial to continue studying the safety and efficacy of these agents which has already been supported by basic science investigation and analysis. This research is critically important to advance the treatment of CLL / SLL and is required by the Food and Drug Administration (FDA) for all new drug approvals.
2. Why should I consider entering a clinical trial?
Entering a clinical trial may allow access to a new drug, combination of drugs, or innovative therapy otherwise not yet available which may offer the best treatment possible. Clinical trial participants contribute to progress in CLL / SLL research and assist in identifying better treatments.
3. What are the advantages?
A clinical trial may offer the most advanced and best treatment option that would otherwise not be available, and which may work better than the standard therapy. In most but not all cases, the test drug may be provided free of cost, and there may be included in the trial additional coverage of specialized tests not normally conducted during routine care. Clinical trial participants also often receive closer monitoring of symptoms and side effects.
4. What are the disadvantages?
The treatment may not be effective. There may be unexpected untoward side effects. Participants may not be able to choose their treatment in the trial, and instead may receive the current standard of care and not the new therapy. There will be additional paperwork, possibly more blood and other tests, including more computerized tomography (CT) scans and bone marrow biopsies, as well as additional medical appointments. There may be additional costs for travel or related expenses as needed.
5. How safe is a clinical trial? Will I be a “guinea pig”?
- Initiating and running a clinical trial requires a long carefully developed and closely monitored multistep process with many levels of strict federal and expert medical oversight.
- First an application for “initial drug approval” must be submitted to the Food and Drug Administration (FDA) which carefully reviews preclinical data from laboratory testing to confirm drug efficacy and safety as well as to review and approve the protocol to be used in the trial.
- Following “initial drug approval” by the FDA, the process then moves to the Institutional Review Board (IRB) of the medical facility which will be running the clinical trial. The IRB following federal guidelines and consisting of expert medical personnel carefully reviews the submitted protocol.
- The IRB makes sure clinical trials are ethical and that the possible benefits outweigh any possible risks in order to approve the study.
- Once underway, a clinical trial must strictly adhere to the treatment protocol and is closely monitored by the IRB.
- The principal investigator must make sure that safety protocols are followed and report findings to the IRB.
- Before enrolling in a trial, participants will be given a detailed informed consent form that has been approved by the IRB, explains the risks and benefits of the new treatment, and enables people to make a fully informed decision
- Clinical trial participants are protected under federal law. Participants have many rights and protections.
So no, you definitely will not be treated like a guinea pig.
6. Could I get a placebo?
Placebos, also known as “sugar pills,” are very rarely used in clinical trials for cancer. They are never used in a study if there is a known effective treatment available. In the unlikely situation that a trial does include a placebo, patients would be fully informed before partaking in the study.
7. What are my rights?
Patients are given extensive information about the trial, ample time to have all their questions answered and are asked to sign an informed consent form before entering a study.
8. What if I want to quit the trial?
You may leave a trial for any reason at any time and without any penalty.
9. What are my costs?
This may vary from trial to trial. Generally, the medication being studied, and research-related tests are covered. Routine tests and treatments that would be considered part of standard treatment for CLL / SLL are usually billed to the patient or insurance policy if it is in place. The definition of routine care varies widely among trials, as many studies do far more extensive and frequent testing than is routinely done in clinical practice. Specific information regarding your costs should be provided to you during the process of and prior to signing the informed consent form to enter the study.
10. Does insurance cover it?
Under federal law most health insurance plans must cover routine costs in clinical trials if you are eligible and partaking in an approved clinical trial. However, insurance may not cover care provided by out-of-network doctors or hospitals, if out-of-network care is not a provision of your insurance plan.
11. What are clinical trial phases?
For a drug to be approved by the Food and Drug Administration it must undergo three distinct phases of clinical testing.
- These phases are described here: Clinical Trial Phases, the Drug Approval Process, and Measuring Responses.
- And for a more in-depth look follow this link to the American Cancer Society: Types and Phases of Clinical Trials.
12. How do I find a clinical trial?
Clinicaltrials.gov is a website listing all US clinical trials and you can use this site to identify and locate a potential clinical trial that you may qualify for.
The Leukemia and Lymphoma Society (LLS) also offers the Nurse Navigator program to individually help you find and navigate the clinical process and can be found here.
13. How do I use clinicaltrials.gov?
This link will take you to an extensive review of how to use this website.
14. What questions should I consider asking before enrolling in a clinical trial?
- What is the purpose of the trial?
- How will it benefit me?
- What have the results been so far in the trial?
- What have been the adverse events (side effects) so far in the trial?
- Have there been any deaths?
- Are any results published for me to review?
- What clinical phase is the trial?
- What will the treatments be?
- What tests are required?
- Will there be additional medical visits?
- What are the risks?
- How is my privacy protected?
- What will my insurance cover?
- What additional costs will I incur?
- How long is the trial?
- Will the results be published and will I be advised?
15. Is participant diversity important in clinical trials?
Yes, people of different race or ethnicities, ages, and genders may react differently to treatments. A drug or treatment may differ in how well it works, in the chances of causing side effects, or in the side effects caused. A broad range of diverse clinical trial participants can help answer these questions.
16. How might I learn more?
This section of our website lists additional information about clinical trials.
A clinical trial might be a smart choice at any point in the treatment journey, not just when running out of options. Trials might research best care during watch and wait, first line and later treatments and when in remission. By participating in a cancer clinical trial, patients with CLL / SLL have access to the newest and most advanced treatments before they are widely available.
Thanks for reading about clinical trials. It is only through clinical trials that old therapies will be improved and any new ones will become available.
We share in this journey together.
Kim Davidson, MD
Kim Davidson received her Doctor of Medicine degree from the Medical College of Virginia. Following training in both Obstetrics and Gynecology and Family Medicine, she provided medical care and taught for over thirty years until recently retiring. She too is a CLL patient and shares in this journey with all of you.
