The U.S. Food and Drug Administration (FDA) last year approved 60 therapies for new or expanded use in the treatment of cancer.1 Those medications vary widely in terms of how they work, the types of cancer they treat, and the circumstances in which they are prescribed, but Iuliana Shapira, MD, explains that they all have one thing in common. “Every single therapy that we are able to offer our patients today is available only because other patients stepped forward in years past to participate in a clinical trial evaluating that agent,” says Dr. Shapira, a board-certified medical oncologist and hematologist who serves as Chief Medical Officer of Regional Cancer Care Associates (RCCA), one of the nation’s largest networks of oncology specialists, serving patients in New Jersey, Connecticut, Massachusetts, and the Washington, D.C., area.
Kimberly Salwitz, MD, a board-certified medical oncologist and hematologist who practices at RCCA’s Little Silver, NJ, office, adds, “Recent data show that approximately 22% of people being treated for cancer participate in some form of clinical research, with about one in three of those people – or 7.1% — enrolling in trials of cancer therapies.2 As an oncologist, I am deeply appreciative of those people and the role they played in enhancing my ability to offer my patients life-saving or life-extending therapies. Everyone affected by cancer owes a debt of gratitude to trial participants.”
Dr. Shapira and Dr. Salwitz say that while involvement with clinical studies is increasing, several misperceptions continue to discourage many people with cancer from participating in trials, slowing the pace of treatment advances. In a recent interview, they noted – and refuted – five common myths about cancer research.
Myth 1: Clinical trials are only for people who have no other options left. Dr. Shapira says, “It’s true that when people have experienced disease progression on approved therapies or cannot tolerate those therapies, we consider whether they may be candidates for a clinical trial, but that is far from the only circumstance in which we assess whether someone could benefit from enrolling in a study. In many other cases, the question is whether someone who is doing well could do even better by adding a therapy to their treatment regimen or, in some cases, by moving from an approved drug to one that has shown even greater promise in initial trials.” In other studies, she adds, therapies that have been approved for use in an advanced stage of cancer are evaluated to determine their effectiveness in early-stage cancer, which is hardly a “last resort” situation.
Myth 2: If I participate in a clinical trial, I will have to stop taking my current medications and could be assigned to the placebo arm of the study, meaning that my cancer would go untreated for the length of the trial. Dr. Salwitz explains that people participating in trials of an investigational agent receive that medication – or placebo – in addition to their other current medications. She continues that when a trial is conducted to compare a newer agent to a current therapy, study participants are assigned to receive one or the other of those agents – not placebo.
The cancer specialist adds, “Clinical trials are governed by very strict ethical standards and must be approved by review boards charged with guarding patient safety and well-being. We do not have patients who have been receiving treatment come off all their therapies. Further, patients are given detailed information about how the study is designed and will be conducted, so that they can make a truly informed decision about whether to participate. And on an important related note, treatment trials include frequent in-person visits, as well as regular phone outreach by study nurses, to closely monitor patients’ health.”
Myth 3: There’s no point in participating in a trial if I have a 50-50 chance of not receiving the drug being studied. Dr. Shapira says, “To understand the efficacy and safety of an investigational therapy, it is important to compare it to placebo or to a currently approved treatment. As a result, during the main part of a trial, a patient may be assigned at random to receive placebo or other therapy. And, because we want study results to be unbiased by physician and patient perceptions, studies typically are conducted in a ‘double-blind’ fashion, meaning that neither the doctor nor the study participant knows whether the patient is receiving the study drug or the comparator. However — and this is a big however — Phase 2 and Phase 3 clinical trials typically have an open-label extension period that follows the main study. This means that after the 24 weeks, 48 weeks, or other duration of that main study, patients who received placebo can “cross over” and receive the study drug on an ongoing basis. Studies are designed in this way to give all participants access to the investigational agent and in order to monitor the long-term efficacy and safety of the therapy in a large population. Furthermore, the study drug typically is provided to participants at no cost during this open-label extension, so even if someone is randomized to the placebo arm of the main study, he or she generally can be assured of receiving the treatment eventually, and at no charge.”
Myth 4: Clinical trials are only conducted at academic medical centers in cities like New York City, Philadelphia, or Boston. Dr. Salwitz says, “The days of having to travel to a major city to participate in a study – or to receive cutting-edge therapies, for that matter – are long past. Over the last 20 years or more, the focus has been on offering both the latest treatments and access to clinical trials in the community, where 80% of cancer care is delivered. Besides being convenient for patients, saving them time and
travel-related stress, this enables people to receive care in a setting where they are well-known to everyone in the practice. RCCA offers patients access to roughly 300 trials across its 26 community-based offices, and people can visit https://www.regionalcancercare.org/all-clinical-trials/ to see which trials are being conducted at which offices.”
Myth 5: My participation in a trial won’t really make a difference. Dr. Shapira says, “The adage that there is strength in numbers is particularly apropos for clinical trials, because the larger the study, the more reliable the findings. So, everyone can make a difference by signing up to be in a trial. Additionally, for too long, cancer trials did not adequately reflect the full U.S. population. White people and adults aged 60 years and younger were disproportionally represented. Of course, cancer strikes people of all races and ethnicities, and the incidence of cancer increases with age. So, it is essential that people from different backgrounds be included in trials and that people older than age 60 – who often were excluded in the past due to safety concerns that have since been largely allayed – be enrolled. A diagnosis of cancer can often make people feel that they have been put in reactive mode – responding to a threat over which they have limited control. Signing up for a clinical trial is a very powerful way to take a proactive approach toward your health and toward helping other people who one day will find themselves where you are now.”
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Dr. Shapira and Dr Salwitz are among 100+ medical oncologists and hematologists who practice with RCCA at 26 locations across New Jersey, Connecticut, Massachusetts, and the Washington, D.C., area. RCCA’s cancer specialists see more than 30,000 new patients each year and provide care to more than 265,000 established patients, collaborating closely with those patients’ other physicians. RCCA physicians offer patients innovative therapies, including immunotherapies and targeted therapy, as well as access to approximately 300 clinical trials. In addition to serving patients who have solid tumors, blood-based cancers, and benign blood disorders, RCCA care centers also provide infusion services to people with a number of non-oncologic conditions — including multiple sclerosis, Crohn’s disease, asthma, iron-deficiency anemia, and rheumatoid arthritis — who take intravenously-administered medications.
To learn more about RCCA, call 1-844-346-7222 or contact us.
References
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