Should People 65 or Older Join Cancer Clinical Trials? An Expert Q&A

June 18, 2020
Brielle Gregory, ASCO staff

This content is adapted from a Cancer.Net podcast recorded in Spanish. This conversation has been edited for length and content.

Enrique Soto, MD, is a geriatric oncologist. A geriatric oncologist specializes in the care of older adults with cancer. Dr. Soto works at the Salvador Zubirán National Institute of Medical Sciences and Nutrition in Mexico City. He is a member of the Cancer.Net Editorial Board. Follow Dr. Soto on Twitter @EnriqueSoto8.

Clinical trials are an important part of improving care for people with cancer. Through clinical trials, researchers find new ways of preventing and treating cancer. Here, Dr. Soto discusses the benefits and potential challenges adults age 65 and older might experience if they choose to find or participate in a clinical trial.

Q: What are clinical trials, and why are they so important for cancer research?

A: A clinical trial is an experiment in which the effectiveness and safety of a new product is tested. This product could be an active substance, a drug, an intervention, or something diagnostic, like a new imaging test or a new laboratory test. The idea of clinical trials is to demonstrate that these new substances, studies, or treatments work for a specific outcome. For example, what do they do so that people with cancer are cured, live longer, or have a better quality of life? It’s very important to carry out these clinical trials because it’s the only way to be sure that new interventions are beneficial for our patients and don’t cause harm.

There are many types of clinical trials, but the most advanced types of clinical trials are “randomized clinical trials.” In these, 2 different treatments are compared. So, we may compare our new treatment or new intervention combined with a long-standing treatment against something that is called a placebo, which is a drug that has no active substance. We see if the people who enter the study and who receive this new compound live longer, are cured, or have a better quality of life. This is incredibly important, because if we are going to give people a new treatment that potentially has costs or side effects, we want to be sure that these treatments make people feel better or live longer and that the new drug or intervention is as safe as possible.

Q: When should people participate in a clinical trial?

A: I think the best answer to that is: always. Whenever people participate in some sort of clinical trial, this helps to increase knowledge and to establish new treatment options. In fact, almost all treatments that we use today have initially been used in clinical trials. So, participating in a clinical trial can ensure that a patient gains many benefits, not just for them, but for others, too.

Unfortunately, this is not always possible, as there aren’t always clinical trials for the specific illness that a patient has and not all cancer centers throughout the world or United States have access to clinical trials. A third point is that not all patients meet the criteria to enter a clinical trial. This is called inclusion criteria, and it can be a problem for older people. All clinical trials set forth a series of criteria, and people who meet these criteria can participate. Those who don’t cannot participate. And, unfortunately, in many clinical studies, the criteria exclude older people because the items on the inclusion criteria are different in older people.

Q: What should older adults know about clinical trials?

A: First of all, older adults should know that there’s no reason why they shouldn’t participate in clinical trials. The other thing they should know is that it’s important to ask about availability of clinical trials. There are interesting studies that show that older people are just as willing or more willing than young people to participate in research studies. So, I think it’s very important that older adults know that these studies exist and that they are available in many places. They also need to ask about these studies and talk with their doctor to see if they are a candidate to take part in one of them -- because this could really benefit them, and not only them, but other people, too.

Q: How can older adults find clinical trials that are right for them?

A: The first and simplest way is to ask their doctor what clinical trials are available in the center where they’re being treated. But also, there are many resources for people looking for clinical trials. For example, Cancer.Net has a dedicated page on finding a clinical trial where there are different links to places where you can search for studies. There are different pages for patient organizations and clinical trials organizations that offer this information, too. One of the most well-known is ClinicalTrials.gov. On this page, you can enter the type of illness you have and where you live, and this shows you a list of different clinical trials and inclusion criteria for each of the studies.

Q: What are the specific challenges older adults may experience when finding or participating in a clinical trial?

A: Older people face many challenges when they try to enter a clinical trial. First, as I mentioned before, is that clinical trials may not be available in their centers. Lots of older people are treated in their community, and sometimes access to clinical trials in the community is much more limited. Second, inclusion criteria for clinical trials can be very strict. So, for example, kidney function or liver function, which are things that are used in clinical trials, may be different in older adults. An older person who is perfectly fine may not be able to enter a study because their kidney function values are higher than those of the younger population, solely because they are older, and that is a problem.

There are many initiatives, including an American Society of Clinical Oncology (ASCO) initiative with Friends of Cancer Research, to change inclusion criteria so that older people can enter clinical trials more easily. The U.S. National Cancer Institute, for example, legally requires that clinical trials contain a significant number of older adults because studies need to be representative of the population. But inclusion criteria are still an obstacle for older people.

Another thing that could be an obstacle for older people is the distance that they have to travel to get to sites that have clinical trials and the number of visits they have to make. Many clinical trials are conducted at sites that are far from where older people live and frequent trips are needed for imaging studies, laboratory studies, etc. For older people who live, for example, in retirement homes or who depend on their families for transportation, this could be a significant obstacle.

Another challenge is this mistaken idea that people who participate in clinical trials are used as guinea pigs, that they’re used as nothing more than experimental subjects, and that they don’t have rights. And it’s very important that people know that participating in a clinical trial does not only have obligations, but that the people participating have rights. Their personal health information must be respected, and participant safety should be safeguarded at all times. For a drug to be tested in a clinical trial, it has to have gone through many prior steps to see that it is safe.

Q: Why is it important for older adults to join clinical trials?

A: The majority of drugs that we use in cancer have mainly been tested on young people. This is because historically, older people haven’t participated in clinical trials. So unfortunately, many of the things that we use to treat older people are not tested on them. So it’s very important that older people participate in clinical trials in order to produce evidence of what really benefits them and what is useful and safe for them. Allowing older adults to participate in clinical trials and encouraging them to join them is the only way we can have concrete evidence of what treatments should be given to older people with cancer.

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