Should I join a clinical trial?

Six questions every patient should ask

by Denise Reinke, SPAGN Board Member.

 

When you have been diagnosed with sarcoma you are faced with making important, and at times, daunting decisions about treatment.

A flood of emotions and questions can quickly become overwhelming and make it challenging to sort out and determine the best treatment for you. You may have talked with other people who have the same type of sarcoma and compared notes. But how does your situation compare with theirs? You likely have sought the advice of family and/or friends. It helps, but they are not standing in your shoes.

There is so much to absorb and learn about sarcoma and treatment when you are first diagnosed or when you get the news that your disease has returned or spread. There may be new terms, new treatments, perhaps even a new clinician. You want to understand it all, weigh all the choices, make the very best decisions so that you can live your normal life as much as possible.

Among the treatment choices, a clinical trial may be an option. But how do you know if it is a good option for you?  Is it something you should even consider?

I would like to address six questions that patients frequently ask me regarding clinical trials. My aim is to help you overcome the hurdle of thinking about a clinical trial for your treatment so that you can determine if it is right for you.

#1 - What is a clinical trial?

A clinical trial or clinical study is a systematic way to test a new medicine, or a new surgical or radiation approach to determine if it will control the sarcoma and/or reduce symptoms associated with the disease.

A clinical trial is the best way to know if something new is better, worse, or the same as what is currently available. A trial details the treatment approach so that everyone is treated precisely the same way, controlling as many variable factors as possible, so that conclusions can be made.

A clinical trial can be designed in a way that everyone on the study receives the new treatment, or  they are randomly assigned to one of two treatments, comparing a new treatment with the current treatment approach. Clinical trials help answer the question whether the new treatment is as effective as the existing one with fewer side effects or perhaps more effective.

#2 – Will I be used as a “guinea pig”?

When you mention a guinea pig, some people think of a small furry animal that they may have had as a pet at one time. But since guinea pigs have been used for doing testing in a laboratory, some people also associate participation in a clinical trial with being used as a "guinea pig”. They fear that something will be done to them for which they have not given their consent or that the trial will only benefit the researchers, who want to carry out “experiments” at the patient’s expense.

This is simply not the case. Research rules and laws have been established to protect people who participate in clinical studies. A trial offers participants the chance receive a new treatment that is not yet approved.

#3 –  How am I a protected as a patient?

International rules, laws, regulations, and guidelines must be followed for clinical trials research to be conducted involving people. There are governmental agencies that oversee, review, and approve research before a trial can be started.

In many countries, hospitals have Institutional Review Boards (IRB) or similar bodies that include people from a variety of backgrounds like scientists, researchers, and patient advocates. They carefully review a proposed clinical trial to make sure that all the regulations are followed, ethical standards are adhered to, and that people participating in the clinical trial are protected from harm.

It is their responsibility to make sure there is a written document for patients that outlines in easy terms and language all the details of why, what, how, as well as the potential risks and/or benefits of a trial. This document is called the consent form. All people who participate in a trial must be informed about the study and they must give their permission to participate.

But informing does not end with simply reading a written explanation. An explanation of the clinical study must be also given verbally to the person who is thinking of participating. Ensuring there is sufficient time to talk, answer questions and concerns is all part of being informed and providing consent.

#4 – Can I get out of a trial?

People always have the right to withdraw from a clinical study at any time. Their clinical team will continue to care for them, offering treatments and care, respecting their decision. Certainly, if someone is considering withdrawing from a study, the potential effects of stopping the study treatment should be discussed with the clinical team so that they can make the best choice for them, their health, and their well-being.

#5 – Why are clinical trials particularly important for sarcoma patients?

Not every sarcoma patient who receives treatments that are currently approved will benefit from them. Unfortunately, we don’t always understand why that is the case. What is it about the same disease in a different person that results in one person benefitting from treatment and not another? Is it something about the disease that is different? Is there something that all those who had a good response to treatment shared? For example, a common genetic alternation or tumor characteristic?

Unless information is gathered and shared about the effectiveness or lack of effectiveness of a treatment, each clinical team will be limited by their own experience in their day-to-day practice. In rare cancers like sarcoma, it can be difficult to have sufficient experience treating enough people with the same disease to draw conclusions and suggest better approaches.

Multi-center clinical trials in sarcoma can be one way to systematically collect and share information to understand what treatment approaches are helpful. Giving the same treatment, delivered in the same way, to people with the same disease in a clinical trial is a powerful way to better understand a disease. Key information can be collected in the trial with the goal of looking at the pooled data to potentially identify a commonality amongst people treated on the clinical study.

Participating in a study can not only contribute to a better understanding of  a specific type of sarcoma, identify a new treatment, but can also be of help to others who will be facing diagnosis and treatment of sarcoma in the future.

#6 – Yes but… What is my benefit?

There are potential benefits for people who participate in clinical studies.

In many parts of the world, newly developed medicines and treatments cannot be given unless they have been previously studied, shown to be effective, and ultimately approved by the regulatory authorities in that country. Clinical trials are the critical path to gaining approval for safe and effective new treatments. Therefore, a clinical study may be a very good option for some people as they will gain access to a new treatment that is not available in any other way.

Remember: the best treatments we have today for sarcoma and cancer were once tested in clinical trials.

 Clinical trials that demonstrate a new treatment is safe and effective are a pathway to having treatments broadly available around the world. We need better treatments. Clinical trials are a way to expand and improve treatment options.

A clinical trial might be right for you

Being diagnosed with cancer like sarcoma can be overwhelming and frightening. We each need to weigh our own situation, the state of our disease, our overall health, the effectiveness of currently approved treatments as well as the potential of a new approach being tested in a clinical trial.

You are not alone. There is a community of people who are willing to connect, share their experience, and provide information. We need to work together to find better options with better outcomes to help people facing sarcoma.

A clinical trial might be just the right approach for you. Ask your team.