The advancements in cancer care over the past decade are nothing short of remarkable. Clinical trials are a powerful tool for discovering new treatments while deepening understanding of how existing treatments may benefit different groups of people. Participation in clinical trials can offer many potential benefits to cancer patients. This article will explore those benefits and the eligibility requirements for participating in a clinical trial.
These new treatments can make a world of difference in someone’s health, and the data gained from clinical trials push the field of oncology forward and helps other cancer patients down the line. While clinical trials are a vital part of cancer research, participants must meet certain eligibility criteria before participating in a clinical trial.
This overview of cancer clinical trials is intended to help potential participants learn more about the process of getting into a clinical trial and determining if the clinical trial process is right for them and their families.
What Are Clinical Trials?
Researchers conduct clinical trials to test new cancer treatments. During a clinical trial, researchers administer the experimental treatment and monitor each patient’s health over an extended period. With the information gained from clinical trials, medical researchers can refine their methods and provide more effective treatments to millions of cancer patients worldwide.
How To Get Into a Clinical Trial
You should speak to your oncologist if you’re curious about clinical trials. Our cancer care experts know the latest developments and can help you find an appropriate clinical trial, determine if it’s right for you, and help get you started on the application process. Even if you find a promising clinical trial, you still need to meet a wide array of eligibility criteria before trying an experimental treatment, so you must manage your expectations after applying.
Eligibility Criteria Definitions
Eligibility criteria are the factors that determine whether you can enroll in a specific clinical trial. Inclusion criteria are all of the factors that will qualify you for a trial, and they describe the ideal patient for the trial treatment. Exclusion criteria are all of the factors that disqualify you from a clinical trial.
Inclusion Criteria for Research
In most cases, researchers need specific subjects to get the most out of their data and propel cancer research forward. Because of this, inclusion criteria are very strict and can vary significantly between different trial treatments. Eligibility criteria commonly relate to:
- An individual’s performance status
- Blood work and other lab results
- Current and past medications
- Other medical conditions
- The type of cancer that a person suffers from
- The extent of a person’s cancer
- The amount of time that has passed since specific treatments
- An individual’s history of other types of cancer
What if I Don’t Fit the Eligibility Criteria?
Many patients with advanced cancer may feel crestfallen after learning they’re ineligible for the latest trials. However, these patients may still be able to try experimental treatments. Researchers sometimes grant eligibility waivers or notable exceptions to patients, and you may be able to try late-phase experimental drugs in an expanded access program. Your oncologist will play a pivotal role in requesting waivers or access to experimental drugs, so you should share your concerns with them to see if you can find a solution.
Before you can enroll in a clinical trial, you must be able to give informed consent. This means that you need to understand the terms of the trial and the potential ramifications of your participation in the trial.
Researchers will send a lengthy consent form that describes the reasons for the study, other treatment options, what the study entails, side effects of the treatment, cost breakdowns, confidentiality statements, contact information, and additional helpful information about the clinical trial. Consider it for a few days and ask your cancer care team plenty of questions before signing the consent form.
Do I Have To Participate Once I Sign an Informed Consent Form?
Researchers conduct clinical trials to learn about new drugs and treatment methods. However, they never put their research ahead of their subjects’ comfort, health, or mental well-being. You have well-being as a patient, so you can opt-out of a clinical trial at any point during the process if you decide that the experimental drug or treatment isn’t right for you.
Researchers will ask you why you’re leaving the study. While you don’t have to give them a reason, a detailed answer can give researchers important insights into the treatment’s side effects and feasibility. In some cases, researchers may want to monitor your health to identify the long-term effects of the trial treatment, but you don’t have to participate if you don’t want to.
Speak to Your Oncologist Today
Clinical trials are a crucial aspect of cancer research. Without willing volunteers and dedicated researchers, the field of oncology would stagnate. Nonetheless, clinical trials aren’t for everyone, and you should never feel pressured to participate in a clinical trial. Hopefully, this information about clinical trials, eligibility criteria definitions, and inclusion and exclusion criteria examples will help you decide if you are willing or able to participate in a clinical trial.