All About Cancer Clinical Trials

If you or a loved one has just been diagnosed with cancer, one of the first things you're asking is: "What do I do now? How can I get treated?"

While there are many different treatment plans that may be beneficial, only you and your treatment team can make the best decision for you.

For some, this may be a traditional treatment, while for others, there may be alternative treatments. For others, the best option is a cancer clinical trial.

Read on to have your most important questions answered.

Why are cancer clinical trials important?

Clinical trials are essentially medical research studies involving people. Medical researchers work to find new ways to improve treatments and patient quality of life through the completion of clinical trials.

Cancer clinical trials are designed to test new ways for diagnosing, treating, and preventing cancer, as well as managing its symptoms and treatment side effects. Cancer clinical trials are the last step of a long process that began with laboratory research.

Prior to using any new treatment for people in clinical trials, many years of research have been put into understanding the effects of treatment on cancer cells and in animals, which can help in determining potential side effects.

Clinical trials are not just for those with advanced cancers that are unresponsive to other treatments. All clinical trials have someone in charge—typically a doctor, known as the principal investigator. This individual prepares the protocol, or plan, for the clinical trial, which explains what will be done throughout the course of the clinical trial.

The protocol also contains information that can help determine if the clinical trial would be a good fit for you.

Other information includes why the trial is being conducted, the eligibility criteria, the number of people needed, treatment details, medical tests required, and information collected. This document is important because it gives detailed information regarding treatment.

Cancer clinical trials are important because they enable medical doctors to save lives. Through clinical trials, doctors are able to determine if the treatment is safe, effective and whether it works better than current treatments.

Clinical trials are also important because they assist in determining ways to both detect and prevent cancer, as well as leading to improvement in the quality of life of patients, not only during treatment but afterward as well.

Cancer clinical trials are beneficial because all participants contribute to the field and improve the care for future patients. 

What are the different types of cancer clinical trials?

There are several different types of cancer clinical trials. Each individual type is designed to answer different questions and help researchers learn different tools for helping patients in the future.

Treatment trials

Most cancer clinical trials are treatment trials. The participants all have cancer and are used to test new treatments or new ways of using existing treatments.

These treatments can include new drugs, vaccines, approaches to radiation/surgical therapy, and combinations of different treatments. Another aspect is to assess treatments that boost the patient's immune system.

Newer treatment trials often require that tumors be tested for genetic changes to determine the most effective treatment option for the patient.

Treatment trials answer questions about safe dosage for new medications, length of time given, impact on longevity and quality of life, impact on tumors (such as shrinking or preventing from growing/spreading), impact on the prevention of recurrence, and side effects.

Prevention trials

Most cancer prevention trials involve people who either do not have cancer but are at high risk for developing the disease or who have had cancer and are at high risk for developing new cancer. The focus of these studies is cancer risk and how the risk can be reduced.

The prevention trials can be divided into action and agent studies. Action studies involve determining if the actions taken by people can prevent cancer. This may be based on more exercise or eating a more healthy diet, for example. Agent studies involve determining if taking certain medicines or dietary supplements (such as vitamins and minerals) can lower the risk of cancer.

Screening trials

Cancer screening trials are designed for the testing of innovative ways to find cancer earlier, allowing for potentially easier treatment. If such a trial is effective, there will be a reduced number of deaths from cancer.

Information of interest from these trials includes the change in prognosis for cancer survival if certain tests are better than others, and if there are unnecessary follow-up tests and procedures as a result of the screening tests.

Palliative care trials

This type of trial is used to learn how to improve the quality of life of cancer patients. These are especially important for those suffering from side effects of both cancer and the treatment. As a result of palliative care trials, new ways are developed to help cancer patients deal with sleep disturbances, depression, pain, nutrition issues, nausea/vomiting, and infection.

In some cases, the trials are used to test drugs and address the side effects, while in other cases, activities are tested. Other trials test ways to help impacted people, such as families, friends, and caregivers.

The focus of palliative care trials is to see how cancer and the treatment of cancer affects patients and their loved ones, and what can improve their quality of life.

Natural history studies

Natural history studies are used to assess the lifespan of cancer. For example, in these studies, those with cancer or at high risk for developing cancer are followed for an extended period of time.

Information of interest gleaned from these studies includes how cancers form and spread, what genes cause cancer, and what prevention and treatments can be used against cancer.

Who is eligible for cancer clinical trials?

There are both inclusion and exclusion criteria for cancer clinical trials. The inclusion criteria allow participants to join, while the exclusion criteria prevent participants from joining.

These criteria are typically related to the type of cancer, stage of cancer, prior treatments, length of time since last treatment, lab test results, current medications taken, other medical conditions, prior history of other cancers, and activity level.

Other considerations may include age or sex. This list consists of basic criteria used to determine who may and may not participate in the clinical trial.

How successful are cancer clinical trials?

In some way, cancer clinical trials are always successful because they contribute to knowledge. However, only about 14%¹ of the treatments win FDA approval.

Although this percentage seems low, this number was previously estimated to be much lower, at about 9% to 11%. Therefore, cancer clinical trials can be considered highly successful.

While every case of cancer is different, the results of cancer clinical trials have led to saving many lives.

How are cancer patients kept safe during clinical trials?

Participants in cancer clinical trials almost always receive treatment. The use of placebos is extremely² rare in clinical trials and only used with the full knowledge of the participants. 

Safety is primarily provided through informed consent.

Informed consent

When approved for participation, the patient is first asked to provide written informed consent. During this stage, the researchers will explain the trial and answer any questions the patient may have.

Consent forms typically include the reason for the study, eligibility criteria, current knowledge regarding the new treatment, potential risks/benefits of treatment, other possible treatments that may work, study design, the number and types of doctor visits/tests required, costs of the trial and who pays them, identity protection, patient rights, and contact information for the researchers. It is important not to rush into a decision.

Once the consent form has been signed, lab tests, such as blood work or imaging tests, may be required before treatment commences. Patients are also asked about their medical history and usually undergo a physical examination. All of this is required to help protect patients from undue harm.

Treatment may require undergoing more tests and doctor visits in order to determine how the treatment is affecting the patient, as well as the overall health of the patient. Most importantly, participants will need to report side effects, whether good or bad.

The full extent of potential problems may not be known, making it critical for the research team to be informed if unusual symptoms arise. This will help determine if the treatment is still safe, if the symptoms need to be treated, and if the treatment needs to be changed.

What are the financial considerations for joining a cancer clinical trial?

If you’re considering participating in a clinical trial, there are financial considerations in relation to patient care costs and research costs³.

Patient care costs

The first is patient care costs, which are related to treating cancer, and are applicable whether a patient is receiving traditional treatment or participating in a trial.

These costs are often covered by health insurance and include visits to the doctor, hospital stays, standard treatments, treatments to improve/resolve symptoms and side effects, lab tests, and imaging tests.

Research costs

Research costs, on the other hand, are related to participating in the trial and are often not covered by health insurance. However, the sponsor of the trial may cover all or some of these expenses. Examples include the drug being studied, lab tests for the research, and additional imaging tests for the research.

It is important to consider the additional hospital/doctor visits that will arise from participating in a cancer trial, potentially leading to increased costs. The additional visits may lead to additional child care, transportation, and housing costs.

How to find a cancer clinical trial

There are different options for finding and applying for cancer clinical trials. To begin with, talk to your doctor for insight on whether or not a clinical trial may be appropriate for your situation. If your doctor believes this may be a viable option, you'll want to do some research.

We help cancer patients find and apply for clinical trials they are eligible for and simplify the medical jargon so you know what to expect.

Get help finding the right trial by searching for your condition here.

Cancer support groups may also be a valuable source of information regarding potential cancer clinical trials. In other cases, talking with other members of your treatment team may help in finding appropriate cancer clinical trials.

While a cancer clinical trial may not be successful in treating your cancer, it will provide invaluable information for the future so future cancer patients will have increased opportunities to survive. Even though there may be risks associated with cancer clinical trials, there are many benefits.

Learn more about finding clinical trials near you.

The lowdown

Cancer clinical trials aren't just for terminal patients, but it's important to go over the eligibility criteria to see if they are the best option for you.

Many of the expenses—but not all of them—are covered, so this is also an important factor to be considered.

Also, inclusion in cancer trials does not mean that a cure will occur because not all trials are successful. However, we now see a much higher success rate than there has been in the past, and many of the drugs that make it through the process are approved for use by the FDA.

Overall, a cancer clinical trial is a great option for many patients, but it isn't appropriate for everyone.

HealthMatch can help you find and apply to the right cancer clinical trial.

Get started by searching for your condition.