Understanding Clinical Trials
- This is SurvivorNet’s guide to clinical trials, where we’ll explain what clinical trials are, why they’re so important and how to go about taking part in one.
- These trials can give patients access to incredible new therapies, or what some would call “tomorrow’s medicine,” today.
- A clinical trial is a research study involving volunteers that looks into using new drugs or therapies. The goal of these studies is to test if new treatments are safe and effective.
- Clinical trials can be an option for people with cancer at many points during the treatment process. Your doctor may have spoken with you about possibly enrolling in a trial if you have advanced disease or if there’s a drug that’s currently considered investigational that may work better than the standard for you.
Sometimes, joining a clinical trial is a good decision.Read More
This is SurvivorNet’s guide to clinical trials, where we’ll explain what clinical trials are, why they’re so important and how to go about taking part in one. These trials can give patients access to incredible new therapies, or what some would call “tomorrow’s medicine,” today. (If you’re looking for a clinical trial, SurvivorNet can help. Check out our clinical trial finder.)
What is a Clinical Trial?
A clinical trial is a research study involving volunteers that looks into using new drugs or therapies. The goal of these studies is to test if new treatments are safe and effective.
Clinical trials can be an option for people with cancer at many points during the treatment process. Your doctor may have spoken with you about possibly enrolling in a trial if you have advanced disease or if there’s a drug that’s currently considered investigational that may work better than the standard for you.
A lot of patients may feel uncomfortable about the thought of participating in a trial, but the trials can provide amazing opportunities for patients. For one thing, they give patients access to a bevy of new drugs that are currently being developed by pharmaceutical companies.
Things to Consider
In the U.S., all new drugs have to go through clinical trials before the FDA will approve them. In addition to being potentially live-saving for patients, these trials are also necessary to advance science and cancer treatments.
However, participating in a trial comes with risks as well, and it’s important to talk to your doctor about this before getting involved in one. Some risks to consider are:
- The risk of harm and/or side effects due to experimental treatments
- Researchers may be unaware of some potential side effects for experimental treatments
- The treatment may not work for you, even if it has worked for others
Still, joining a clinical trial comes with benefits as well. You will be given access to treatments that could be life-saving, but simply haven’t made it through the approval process yet.
If participating in a clinical trial is something you think you may be interested in, the government has a list of trials that are currently ongoing. SurvivorNet also has a tool to help you find trials for your particular disease.
Understanding Informed Consent
The informed consent process for a clinical trial will usually involve the research team presenting you with both standard consent forms as well as any other relevant information you may need about the treatments to know whether you wish to begin a clinical trial or stay in one if you’re already enrolled.
Before you enroll in a trial, you must be given the opportunity to read the consent documents fully and to ask any questions you may have. The documents will likely contain the following:
- The purpose of the research
- Any risks and benefits expected from the research
- Information about procedures that may cause discomfort (like frequent blood tests)
- Any alternative procedures the patient might consider instead
- How the patient’s information will be kept private
- How long the study is expected to take
- A form confirming you are participating in research voluntarily
- Whether any compensation or additional medical care is available if some sort of injury occurs
- The patient’s rights (like the right to stop research in the middle of the trial)
- Contacts for any patient questions
During the time that you are participating in a clinical trial, the researchers may also make new discoveries that could affect you and how you’re being treated. At this point, they may ask you to sign a new consent form or you may decide you no longer want to be a part of the trial. Patients are allowed to walk away at any time during the trial.
Understanding your rights as a voluntary patient is important before you take part in a clinical trial, and understanding that the treatment may not work is crucial as well.
Who Can Sign Up for Clinical Trials?
If you’re interested in taking part in a clinical trial, the first thing to do is to speak to your doctor about the possibility of a trial. Blindly searching trials on the internet might not be the best advice available; using either the government’s clinical trials database or SurvivorNet’s resources specifically for cancer patients is your best option.
Dr. Nina Shah says if you’re interested in a new treatment, don’t be afraid to ask questions.
However, just because you’re willing to take part in a clinical trial doesn’t necessarily mean you will be able to join. These trials have specific criteria that patients need to meet in order to take part. At the end of the day, even though these trials can have incredible results and provide you with access to cutting-edge therapies, these are controlled experiments.
For each trial, there will be certain inclusion and exclusion criteria.
Sometimes, patients may be excluded from certain trials if their cancer has spread to their brain. If the metastases aren’t under control, the patient may be unable to participate because researchers are concerned that they won’t be able to complete the whole study.
There are options for people who may not be eligible for the clinical trials they wish to participate in, but still want to try the therapies. A few years ago, the U.S. passed something called “Right to Try” legislation. This gives terminally ill people access to highly experimental drugs that are in “phase one” of the clinical trial process.
Your doctor may also request access to a single patient IND (investigational new drug) on your behalf, which can also give access to treatments that the FDA has not yet approved.
What’s it Like to be Part of a Clinical Trial?
The clinical trial experience is different for everyone who participates in them. Obviously, some patients will experience great outcomes while others will either have no response at all or see their conditions worsen.
We want to wrap up this guide with two success stories, as well as one recent study on how clinical trials for cancer in particular could do with some improvement.
Participating in a trial is not a decision to make lightly. While there are so many potential benefits — including the possibility of remission — there are also serious risks.