Things to Keep in Mind Before Joining a Clinical Trial

Treatment // June 14, 2017

Every new cancer treatment and diagnostic method comes from years of research and testing. Through the different phases of clinical trials, researchers learn what is and isn’t effective, any side effects, and potentially discover a new standard for how we approach cancer care.

Clinical trials are so important for every kind of cancer and disease, and can have an even larger impact on rare cancers like mesothelioma. This asbestos-caused cancer takes decades to develop, meaning most patients receive a proper diagnosis at a later stage. While early detection can certainly influence a patient’s prognosis, mesothelioma is still notoriously difficult to treat. Developing new treatments or determining new combinations of therapies through clinical trials have the potential to give these patients, who initially face just 12 – 21 months survival, their lives back.

For some patients, finding a clinical trial to join in the face of a dire prognosis can feel like finding a gold mine. For others, it can be a more conflicted, difficult decision to make. Much like any decision we make in life, there are positives and negatives to pursuing a clinical trial.

An Informed Decision

Besides discussing with your oncologist and doing research on your own about any clinical trials you may be eligible for, the clinical trial itself begins with an informed consent form. The form will include information from the master protocol, the detailed plan for how the clinical trial will be conducted and its intended purpose. Additionally, the informed consent form will detail the possible risks and benefits the participants should expect.

Those considering a clinical trial should also keep in mind this informed consent doesn’t end with signing up for the trial. Throughout the study, participants must be informed of any new risks or potential side effects that surface and will be required to sign updated consent forms to continue in the trial.

For many, the fear of the unknown can hold them back from wanting to participate. While there will still be a lot of unknowns throughout the duration of the trial, like whether or not the new treatment will work for an individual case, patients should understand that they are in control of much of the process itself. Joining a clinical trial is entirely voluntary and not binding in any way. Patients can choose to leave before or during the trial at anytime.

Choosing any course of treatment can be a big decision, and it’s always important to make an informed decision. Researchers always ensure patients fully understand what to expect by joining the trial so they can make the best decision for themselves.

Access to New Treatment

The chance of receiving a new, promising treatment is probably the main reason patients decide to join a clinical trial. Sometimes it’s a final option when they are not responding well to the standard treatment. For many mesothelioma patients, joining a clinical trial is their best chance at long-term survival.

Patients don’t have any guarantees, however. In general, many clinical trials randomly select groups of patients for a controlled group and another group that will receive the experimental treatment. So there’s a chance participating will mean a patient still only receives the standard treatment. Patients able to try the new treatment don’t have any guarantees either. Even if the therapy works for some, it could prove ineffective for the individual or not as effective as the standard treatment overall.

Regardless, this research goes well beyond patients in the current study. If these new treatments or treatment applications prove successful, future patients will have more, better options to (hopefully) successfully beat their cancer. For those facing a disease like mesothelioma, where only 30 – 40% of patients live over one year after diagnosis, the possibility of a more effective treatment to beat those odds means everything.

Immunotherapy has been an exciting emerging treatment that has shown promise for many cancers, including mesothelioma. Researchers are especially excited by a newer cancer drug, Keytruda, that has already been approved to treat melanoma and non-small cell lung cancer. It has shown promising results for some mesothelioma patients so far, and hopefully will continue to show improved effectiveness as studies continue.

Learn more about emerging treatments for mesothelioma

Facing Side Effects

The side effects of a cancer drug still being studied can be potentially positive or negative. In early phases of clinical trials especially, the potential side effects, safety, and effectiveness of the treatments are still being ascertained.

In some cases, patients may experience less side effects than they would undergoing more conventional treatments. But some may face more or worse side effects than they otherwise would. While the researchers will lay out some of the potential side effects in the informed consent process, they will not always be aware of all the potential risks ahead of time. Since each cancer case is unique, it can also be difficult to determine just how an individual will react to a certain cancer drug.

If a patient does begin to experience side effects, their doctor may be able to recommend lifestyle or dietary changes to help better manage them.

Additional Tests and Procedures

Patients should also consider the potential time commitment and additional costs that may be associated with joining a clinical trial. Typically, patients have to undergo more tests and scans to understand how their body is reacting to this new treatment. This could entail more doctor’s visits, and in some cases may even require periods of hospitalization.

For some, being more closely monitored may be more reassuring, while others may find it difficult to commit to. It can be especially difficult if participation entails a lot of travel. Mesothelioma specialists are scattered around the country, so a patient may have to travel far even when seeking standard treatment.

Another factor to consider with these additional tests is the cost. Most health insurance plans will not cover the additional care required from a clinical trial. Health insurance will cover routine patient care costs, like treatment for side effects and imaging work, while a patient is in a clinical trial if:

  • The patient is eligible for the particular clinical trial;
  • The trial is federally approved and funded, and have submitted an application for FDA approval of the drug; and
  • The trial only involves in-network hospitals and doctors.

Any research associated costs, like extra doctor’s visits or lab work, will often not be covered by insurance because it goes beyond the scope of standard treatment costs. In some cases, however, these additional costs may be funded by the sponsor of the trial.

Ultimately, deciding to join a clinical trial is a very personal choice with many considerations to keep in mind. There are no guarantees in choosing a clinical trial over standard treatment or vice versa. But clinical trials and their participants can greatly benefit future patients and potentially bring researchers that much closer to a cure.