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Misconceptions about clinical trials are common. Many people with lymphoma never consider participating in a research study, and they may miss out on opportunities that could present the most effective treatment option for their condition.
MyLymphomaTeam talked with Dr. Robert Dean to find out the truth behind some of the fears and misunderstandings regarding participation in lymphoma research.
Dr. Dean is board-certified in medical oncology and hematology. He is a member of the department of hematology and medical oncology at Cleveland Clinic Taussig Cancer Institute, and an assistant professor in the department of medicine at Case Western Reserve University.
I think the biggest barrier for most patients to enroll in a clinical trial for cancer treatment is a combination of fear and lacking information. It's easy to understand how someone who's dealing with a new cancer diagnosis, or cancer that has come back, is worried about what will happen and whether their treatment will be successful. And a lot of people don't know what's involved in receiving treatment as part of a clinical trial — how it's similar to being treated with standard-of-care treatments outside of a study, and where the differences really lie. It's important for people to have a discussion openly with their oncology care teams about those questions.
I would suggest that they start by asking:
 | Is there a clinical trial that I should consider as an option for my lymphoma treatment? |
| How is the treatment in a clinical trial similar to the standard treatment I might receive if I weren't participating in a study? |
| How is it different from the treatment that I might receive if I weren't participating in a study? |
Depending on the patient’s situation, a clinical trial may involve something that's very close to the standard of care, or it may involve an opportunity to try something that's new and different from standard treatments that maybe didn't work that well for them.
In most cases, treatments in a clinical trial for people who have never received cancer treatment before are based upon our standard treatments or very similar approaches, with the addition of a new drug or another new aspect to the treatment.
Sometimes, patients may have the opportunity to try a treatment that is newer and might belong to a totally new class of drugs. For example, we talked about the targeted drug ibrutinib (Imbruvica) being a very effective drug for some blood cancers. The patients in those first clinical trials had very high success rates, which led that drug to being brought to market fairly quickly. But it must have felt like a leap of faith for the very first patients to try that treatment, as a previously untested drug that worked in a different way from other available drugs.
I think a lot of people would really be surprised and reassured by just how much effort and attention are put into making sure that someone's rights are protected when they're participating in a clinical trial. There are a lot of layers to this.
When a treatment or drug is being tested as part of a clinical trial, the plan is spelled out in advance in great detail, based on all the research that's been done with that treatment or drug up to that point. There's already going to be some information about how the drug performed in laboratory tests or earlier trials, what kind of side effects are known, and at what doses those side effects were seen. As drugs advance further in clinical trials, the focus shifts to getting a better understanding of how effective the drugs are at treating the cancer that is being studied or treated. So, one important right for patients who participate in a clinical trial is to understand what is already known about the treatment, and what the possible side effects or risks of the treatment are, to the extent that those factors are known.
Another important right of patients who decide to participate in a clinical trial is that if new information comes out about the treatment as they're receiving it, then they need to be informed of that. If the new information potentially changes their risk, they have the opportunity to consider whether continuing treatment on the trial is still the right decision.
The second layer of protecting your rights is knowing that clinical trials are regulated very carefully by an extensive system that involves both the U.S. Food and Drug Administration at the national level, and by oversight at the local level where the patient is receiving care. The FDA oversees the conduct of clinical trials, making sure that they're scientifically sound, are not putting patients at any unnecessary risk, requiring that patients understand the known risks of a treatment before it begins, and enforcing the prompt and accurate reporting of the risks and results of treatments on clinical trials.
Those risks and other details about the treatment are spelled out in an informed consent document that is written in plain language. A patient who is considering participating in a clinical trial is presented with a copy of that consent form, given the opportunity to read that at length at their own pace, and offered the chance to ask and have answered any questions that they have before they make a decision.
At the local level, there will be an organization called an institutional review board (IRB) that oversees the conduct of clinical trials at that location. The IRB reviews all of the clinical trials at the site to make sure that they're being conducted in a manner that explains and minimizes the risk to patients and follows all best practices. The IRB also reviews the informed consent document to make sure that it's complete, thorough, and readable.
Even after a patient agrees to receive treatment as part of a clinical trial, they still have a lot of say in what happens to them. They can discontinue their treatment on a trial at any time. If there are aspects of the clinical trial that they find problematic, then they should discuss those concerns with their doctors to learn why the study includes those procedures and whether they are required. As the team responsible for both your care and the research study, it's our obligation to address those questions for our patients, not just when they're considering whether to sign up for treatment on the trial, but at every point along the way.
How we protect your privacy rights in a clinical trial is explained as part of the informed consent process. We don't share your identity with any third party unless it's required by law to do so. For example, if a medical facility were being audited by the FDA to confirm that we were following all the appropriate rules and regulations, then the agency would have the legal authority to review patient records to confirm that we were accurately documenting informed consent, following the protocol for treatment, and reporting the results as required. But none of that information would be subject to public release.
There are other regulations that govern people's privacy for their health care, whether as part of a clinical trial or during routine standard treatment, including the Health Insurance Portability and Accountability Act (HIPAA). For instance, genetic information or other sensitive health data could never be shared with a health insurance company or sold to a third party in a way that allowed an individual patient to be identified.
For procedures or treatments that are billed to a health insurance company, they would have information that certain tests were performed, but not the results of that testing, unless they required it to approve coverage for another standard-of-care procedure.
A person's out-of-pocket costs for participation in a clinical trial should not be significantly different from what their out-of-pocket costs might be based on their insurance coverage for receiving a standard program of treatment. Everything that is standard of care is billed to health insurance, while everything that is considered outside of standard of care is paid for separately through a study budget that covers all of those costs. And, in cases where a clinical trial might ask for patients to do additional things that could pose a financial burden — for example, making extra trips to the cancer center or staying overnight to have additional testing done — budgets for clinical trials will often include reimbursement funds to help cover those additional out-of-pocket costs for patients.
For almost any situation, there’s a standard treatment for people with cancer. It's not a question of, “Am I getting a drug for treatment or am I not getting any treatment?” Rather, it's a question of whether you’re getting standard treatment only, or standard treatment plus something extra.
Rarely, cancer treatment on a clinical trial that includes a placebo-only treatment still makes sense, usually in cases where no standard treatment is known to be effective. But most of the time, a placebo is used when we're trying to figure out whether something added to our current standard best care yields better results or not. The gold standard way of answering that question is with a controlled trial where patients are randomly assigned a standard treatment with or without an experimental drug, but neither the patient nor their care team knows if what they're getting is the standard treatment alone, or the standard treatment plus the experimental drug. But you will be told upfront before the trial starts if you might get that kind of a placebo (sometimes referred to as a sham drug) along with the standard drugs in your treatment.
That's not true at all. In many circumstances, a clinical trial is a good fit for someone right upfront when they're embarking on their very first course of treatment.
Yes, there is a large network of community-based oncology practices that collaborate to conduct clinical trials, typically with common cancers that have existing standards of care, but that have room for improvement.
For people who want to travel to larger research institutions for more experimental treatments, there is sometimes funding to defray some of the potential out-of-pocket costs. For example, the Leukemia & Lymphoma Society often provides financial grants to help people with blood cancers with a number of expenses, including travel. Some people's insurance plans also include a clinical trial benefit, where they'll provide some money to help cover those kinds of out-of-pocket costs, too. If you're thinking about a clinical trial as an option, but the potential costs are a barrier, check with your health plan. You can also ask if your oncology doctor's office has a social worker or a nurse coordinator navigator who can help you identify resources and apply for them.
It depends on the trial. There are some clinical trials where the treatment is given for a defined period of time, and then it stops. In some studies of new treatments for people whose cancers had relapsed, people who are benefiting from the treatment and tolerating it OK can continue on that treatment in an open-ended manner. If the treatment ends up receiving FDA approval, then the patient will often transition to receiving the treatment through commercial insurance coverage rather than through the clinical trial. We certainly want people to maintain access to a treatment that's helping them, if it's working well for them.
Absolutely. As your treating doctor, my first obligation is to you and your health, and not to the study. If I can tell that that treatment is no longer helping you in terms of controlling your cancer, or if it's helping your cancer but causing significant health problems, then I have to do what's right for you. And in the case of clinical trial treatment that's no longer effective for somebody, we discontinue the treatment. The patient withdraws from the clinical trial, and we move on to a different option.
It depends on the study, which depends, in part, on the drug. There are some drugs that are meant to be given for a limited duration of time, then they’re discontinued and people are monitored to see how long that response to the treatment lasts. For other drugs, they may be designed to be taken for a much longer period of time. So it varies from study to study and drug to drug, but the length of time can be anywhere from a matter of months to years.
There's often a follow-up period of a couple of years or longer, during which they have completed their treatment on a clinical trial, but their health status is still being monitored. Follow-up periods help determine how long remission lasts, check for any delayed side effects, and determine how long it takes for any side effects that occurred during the treatment to go away.
You certainly can, even if they aren’t the team that is providing the study treatment. Depending on the study and where it's available, your oncologist, who has known you for years, may be in the best position to help monitor for symptoms in between study visits, help with evaluating any symptoms through blood tests or scans, and be accessible and available for anything that comes up.
It's also important to let your study team know if you have any symptoms that need to be treated in your local clinic or hospital. A big part of protecting the safety of patients in clinical trials is to collect information about any risks or side effects related to the treatment, and to report those in a timely and centralized way.
A good place to start is to talk with your doctor and see if they're aware of any clinical trials that would be a good fit for your situation. Also, it never hurts to get a second opinion from someone else who's an expert in the care of your cancer and who's familiar with what clinical trials are available.
You can also do some homework of your own. The National Institutes of Health (NIH) is the government-funded agency that supports medical research in all areas of health. The organization maintains a centralized database of clinical trials for all kinds of diseases, all around the country at ClinicalTrials.gov. Some nonprofit organizations, such as the Leukemia & Lymphoma Society, help patients find clinical trials.
On MyLymphomaTeam, the social network for people with lymphoma and their loved ones, more than 12,000 members come together to ask questions, give advice, and share their stories with those who understand life with lymphoma.
Learn more about when and why participating in a research study for lymphoma might be right for you.
Read more about recent advances in lymphoma treatment.
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Robert Dean, M.D.
is a staff physician in the department of hematology and medical oncology at the Cleveland Clinic Taussig Cancer Institute.
Learn more about him here.
Kelly Crumrin
is a senior editor at MyHealthTeam and leads the creation of content that educates and empowers people with chronic illnesses.
Learn more about her here.
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