Clinical trials are an effective way for researchers to provide new medical, surgical or behavioral standards of care to patients facing any type of disease at any stage. Howard S. Hochster, MD, FACP, is the director of oncology research for RWJBarnabas Health, as well as the associate director for clinical research and the director of GI Oncology for the Rutgers Cancer Institute of New Jersey. We asked him who should seek a clinical trial, what to ask your doctor before enrolling in one, expanding access, how it can change the course of cancer treatment and more.
New Jersey Family: How do clinical trials work?
Dr. Howard Hochster: Clinical research brings what we learned from laboratories to people. We’re looking into medical records and getting information from patients to help us understand this new treatment. Usually when we say clinical trial, though, we mean an intervention whose goal is to help improve treatment. Clinical trials can involve any aspect of what we’re treating in a patient or we’re learning about their condition.
A clinical trial is always an important consideration whenever you decide on any cancer treatment, and you should look into these options before you decide to go ahead with standard therapy. The National Cancer Institute supports hundreds of trials in all kinds of hospitals across the country, with 225 clinical trials open for treatment at the Cancer Institute of New Jersey. Every medication that has been approved by the FDA must show it’s beneficial to people through a series of clinical trials. As a participant in a clinical trial, you can receive treatment earlier–before FDA approval–with more attention to your treatment and safety than you do in standard treatments.
NJF: Who should seek a clinical trial and how do they go about enrolling?
Dr. Hochster: Anyone can ask their doctor about trials, and there are many patient advocacy groups for different kinds of cancer and other diseases. You can also go to a website run by the U.S. government called clinicaltrials.gov; all clinical research in the U.S. and often a lot of international research must be listed there. You can search by institution, by location and by disease diagnosis to find clinical trials that may be available.
Usually, we want to take patients who are relatively healthy, without many abnormalities, because then we may not be able to tell if side effects are due to the toxicity of the treatment or just because the person is already sick. We have eligibility criteria, which usually allow a certain level of abnormalities, but if you fall outside of those, then you may not be eligible for a trial. Sometimes, it can be a bit of a challenge for cancer patients who have been treated for a long time and are generally ill to enter clinical trials.
NJF: Are clinical trials the last or only option a person has?
Dr. Hochster: No. We have clinical trials in every stage of cancer treatment. Many of the trials are bringing new treatments into first-line therapy (that is, initial treatment after diagnosis), adding new or novel drugs to the current standard therapy, or trying to replace the current first-line therapy with a better regimen that will be more effective or less toxic. Clinical trials are definitely not only for late-stage cancers where there are no other alternatives.
Clinical trials are bringing tomorrow’s treatments to our patients today. We are participating in such trials to get these drugs approved by the FDA, so in trials they can be given even before they become generally available. I have personally been involved in trials that have led to the approval of probably 30 drugs over my career, and it’s made a huge difference in treatment for cancer.
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NJF: If someone is interested in a clinical trial, what questions should they ask their doctor?
Dr. Hochster: I think the important questions to ask are:
- What are the pros and cons of being in the trial?
- What are the likely side effects and what are the likely benefits?
- How can I expect to benefit from the trial?
- If I don’t go into trial, what are my alternatives?
- Do I have good alternative therapies?
Many of our early trials are randomized because the only way we can know if adding a new drug to the other two or three works is by comparing it to the standard treatment, but there are also many non-randomized trials.
NJF: How successful are clinical trials, in general?
Dr. Hochster: Every cancer is a little different, but the new medications that are coming to the clinic over the last 10 years have made a huge difference in many diseases. In colon cancer, which is my area of specialty, when I started practicing we had one drug, and if you had metastatic colon cancer, the median survival was around one year; now it’s about four years, and we have about eight drugs available. We have made a lot of improvements in treatment and helping people live better for much longer.
NJF: How can you alleviate some of the fears surrounding clinical trials, especially the concern of being given a placebo?
Dr. Hochster: Some people join clinical trials as a public service to improve treatment for everyone. No matter the stage of a person’s illness during the start of a clinical trial, it is important to compare it against the standard treatment itself. At times, the only way to receive a new drug is through a clinical trial. And, some people are under the impression that, “If I go into a trial, I’ll be like a guinea pig,” thinking that they’re a research subject for something that isn’t well justified.
However, by the time any one of these drugs or treatment protocols gets to individual patients, it has undergone a lot of scrutiny and a lot of review for scientific validity and for safety and potential benefit. Each trial goes through continued review by scientific peers as part of an Institutional Review Board (IRB) for safety and benefit. Also, our IRBs ensure that anyone who participates in a trial does so with consent and is aware of the risks and benefits of being in the trial. This informed consent document also tells you what the alternatives are to participating in a clinical trial.
Generally, we don’t conduct trials unless there is sufficient preliminary work to show it would be worthwhile, because trials are very time-consuming. In some cases, we may discover that the standard therapies are effective but the new therapy works better.
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NJF: What happens if a patient finds themselves in a situation where the clinical trial isn’t working for them?
Dr. Hochster: If a treatment isn’t working, we stop it. We don’t want to keep people on a treatment that is not effective. If the person is having too many side effects, usually we have built-in dose reductions and treatment modifications to make it easier for people to tolerate. But anybody can stop participation in a clinical trial anytime they wish if they feel it is no longer in their best interest. Then it would depend on what the standard treatments were.
We have several treatments now for people who’ve gone through all the standard drugs. Then, if those kinds of cancer-specific trials aren’t effective, we have what we call Phase I studies. In Phase I studies, we’re looking to find out more about how to give new drugs, and such trials tend to be open to a lot more people and are not diagnosis-specific. Those are often available to people who want to continue to receive treatment when all the standard treatments have been exhausted.
NJF: Why has there been some distrust around clinical trials, and how can people be sure their best interests are at heart?
Dr. Hochster: Since the time of World War II, with experiments performed on people under duress, it is considered unethical to experiment on people without their consent, understanding of what they’re engaged in, and understanding the alternatives to trial participation. As I mentioned previously, we have groups called IRBs/committees to ensure trials respect the rights and privacy of all people enrolled in trials.
NJF: Have you found that clinical trials tend to attract a diverse population? Are there barriers such as transportation, insurance funding and language or cultural barriers where not everyone is receiving that same access?
Dr. Hochster: I think our healthcare system has a lot of inequity in healthcare delivery to people who are underinsured and of various ethnicities. We try to work through that at Rutgers Cancer Institute of New Jersey through our community outreach and engagement efforts, where we are trying to reach the communities where people are underrepresented in clinical trials and help such individuals understand what clinical trials are and how to enroll in them.
We want to be sure that the people participating in trials represent our New Jersey community and in 2022, we saw just under half of all participants come from underrepresented and minority groups, which about matches the composition of ethnicities and minorities in the State of New Jersey. Some of this success is due to a lot of outreach, and also to our many research personnel who are of those same ethnicities. We also make all consent forms available in Spanish and other languages that are common among our population.
NJF: What message would you share with anyone facing treatment or a clinical trial?
Dr. Hochster: I encourage people to do screenings early because we’re seeing many younger people with cancer. When it comes to clinical trials, I think the main thing is that we can only make progress with your help by participation in clinical trials. Our goal is to bring you tomorrow’s treatment today.
Thinking about screening for yourself or someone you love? Start by talking to your primary care doctor about screening options or contact ScreenNJ, a cancer prevention, screening, and early detection program brought to you by Rutgers Cancer Institute of New Jersey, the NJ Department of Health, and healthcare and community organizations statewide.
As the Associate Director for Clinical Research and Director of Gastrointestinal (GI) Oncology, Dr. Howard S. Hochster shares the vision of the Rutgers Cancer Institute leadership of a unified, robust, and broad-based clinical trials program. In these roles, and as Director of Oncology Research for RWJBarnabas it is his goal to bring the very best clinical trials to patients in the Garden State, at both Rutgers Cancer Institute and across the many hospitals of RWJBarnabas Health.
Dr. Hochster’s clinical expertise includes GI Cancers, colon cancer, pancreatic cancer, biliary cancers and neuroendocrine tumors. His research interests are dedicated to early drug development and clinical pharmacology, focused on tumors of the gastrointestinal tract. Dr. Hochster has led numerous clinical trials and has been at the forefront of clinical research in GI Oncology and has been instrumental in the approval of eight new drugs for the treatment of colon cancer. His vision is to bring the very best in treatment via clinical trials and clinical research to the people of New Jersey and to make the Rutgers Cancer Institute a treatment destination venue for patients around the world. To learn more about Dr. Hochster or to make an appointment, click here.
