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Clinical trials are also known as interventional studies. They examine the safety or effectiveness of a medical treatment, test, tool, or other intervention.
Your doctor might recommend a clinical trial if they think you can benefit from the intervention that the trial is studying. They might also encourage you to participate so researchers can learn from your experiences.
It’s important for researchers to include diverse groups of people in clinical trials so they can learn how treatments or other interventions affect people of different ages, sexes, races, ethnicities, and socioeconomic statuses. This may help researchers and other experts limit or address inequalities in healthcare.
Sometimes, taking part in a clinical trial may allow you to access certain care that you wouldn’t have access to outside the study. This might include a new drug other treatment, which may or may not have benefits for managing your condition.
Participating in a clinical trial might also be appealing if you want to help researchers learn about lung cancer and ways to support people with this condition.
There are risks involved in taking part in clinical trials. However, understanding your options can help you make informed decisions.
Types of clinical trials for lung cancer
Different clinical trials focus on different types of interventions and use different methods to study them.
Clinical trials may be:
- uncontrolled or controlled
- nonrandomized or randomized
- unblinded or blinded
Each type is described below.
Here are some of the interventions a clinical trial for lung cancer may study:
- a new approach for preventing lung cancer
- a new technique or tool for screening for lung cancer
- a new technique or tool for diagnosing, typing, or staging lung cancer
- a new treatment for lung cancer, such as a:
- chemotherapy, immunotherapy, or targeted therapy drug
- surgical technique or tool
- radiation therapy technique
- a new way to promote behavioral change to prevent or manage lung cancer
- a new supportive care therapy or program for improving quality of life
- a new way to use or combine existing treatments, techniques, or tools
If you decide to take part in a clinical trial, the researchers may ask you to take certain treatments or other interventions. They may conduct physical exams, order medical tests, or ask you to fill out surveys or questionnaires to learn how the intervention is affecting you.
As you consider participating in a cancer clinical trial, it can be helpful to know that the procedures used by the research team have been previously approved by scientists and regulatory officials to ensure high quality and improved outcomes for people with cancer.
Uncontrolled vs. controlled
In an uncontrolled clinical trial, every participant receives the treatment or intervention that the study is focused on.
In a controlled clinical trial, participants are assigned to different groups:
- Investigational group: This is sometimes known as the experimental or active treatment group. Participants in this group get the treatment or intervention that the study is focused on.
- Control group: Participants in this group get either no treatment, a placebo or sham treatment, or a different treatment or intervention than the one that the study is focused on.
A placebo or sham treatment is something that resembles a real treatment but isn’t one. For example, a placebo pill contains no real medication.
However, most clinical trials for cancer compare an intervention to the current standard treatment or a similar treatment instead of a placebo, sham treatment, or no treatment. There are no additional risks to people in the control group.
Some clinical trials have a crossover design, which means that participants switch from one group to another at a certain point in the study.
Nonrandomized vs. randomized
Controlled trials may be nonrandomized or randomized.
In a nonrandomized controlled trial (NRCT), the participant or research team decides which group the participant will be in.
In a randomized controlled trial (RCT), the research team randomly assigns each participant to the investigational or control group.
RCTs may be unblinded, single-blinded, or double-blinded.
In an unblinded RCT, the participants and researchers know which group the participants have been assigned to and what type of treatment or intervention they’re receiving.
In a single-blinded RCT, the researchers know which group the participants have been assigned to, but the participants don’t know.
In a double-blinded RCT, neither the researchers nor the participants know which group the participants have been assigned to until after all the data has been collected.
Blinding the study helps reduce the risk of bias, or unintentional influence on the results. Although blinding is not always possible, researchers apply other measures to reduce the risk of biases.
Researchers often conduct multiple phases of clinical trials to learn how safe and effective a treatment or other intervention is. Each phase helps them answer different questions.
Researchers study how an intervention affects a small group of people to learn how safe it is and what side effects it causes.
Researchers study the intervention in a larger group of people to learn how well it works and collect more information about its safety and side effects.
Phase 2 trials may include up to several hundred people.
Researchers study the intervention in a larger group of people to:
- confirm how well it works
- monitor participants for side effects and adverse reactions
- compare the intervention with current treatment standards or similar treatments
- collect information that will help people use the intervention safely in the real world
Phase 3 trials may include several hundred to several thousand people.
This type of clinical trial happens after the Food and Drug Administration (FDA) has approved an intervention and it has become available to the public.
Researchers track the safety of the intervention in the real world and collect more information about its benefits as well as the best ways to use it.
Eligibility and screening
Eligibility criteria are the rules that researchers set for who can take part in a trial.
Clinical trials have inclusion and exclusion criteria. The inclusion criteria describe which people can participate in the trial, and the exclusion criteria describe which people are not permitted to participate.
The inclusion and exclusion criteria vary from trial to trial, depending on the questions that researchers want to answer, the methods they plan to use, and the risks for participants.
Eligibility criteria may address factors such as:
- your sex or age
- the type or stage of lung cancer you have
- whether you’ve gotten certain treatments before the trial
- whether you’ve developed certain complications or have certain health conditions that may affect the risks of the intervention or the research results
A member of the research team will check to make sure you meet the eligibility criteria before you enroll in a clinical trial. They may ask you questions, review your medical records, conduct physical exams, or order medical tests to learn whether you’re eligible.
All clinical trials require participants to complete an informed consent process. This helps you learn what a trial will involve before you decide whether or not to take part in it.
During the informed consent process, you will get a document that describes:
- the goal of the trial
- the eligibility criteria for who can take part in the trial
- what treatments, tests, or other procedures you would get during the trial
- what information the researchers would collect from you and how they would use it
- whether there would be any costs or payments involved in your participation
- the known benefits and risks of taking part in the trial
- how long the trial will last
A member of the research team may review this information with you verbally or share other materials to help you learn about the trial. They may be able to provide an interpreter or translator if English isn’t your first language.
The informed consent document should also include contact information for a member of the research team so you can reach out with any questions you may have.
Consider asking whether the trial has been approved by an Institutional Review Board (IRB). This is an organization that reviews research protocols to make sure the researchers have a plan to reduce risks and protect privacy for participants.
If you decide to take part in the trial, the research team will ask you to sign a consent form.
Even if you sign the consent form, you have the right to change your mind and withdraw from the trial at any time.
Clinical trial sponsors are individuals or organizations that oversee or pay for studies.
If you take part in a trial, the trial sponsor or funder may or may not cover the costs of:
- clinic visits that you have as part of the trial
- treatments, procedures, or tests that you get as part of the trial
- research-related travel costs, such as parking, meals, or accommodations
Talk with the research team to learn which costs will be covered or not. Ask whether you will need to pay for any tests, treatments, or other care that you get in the trial. Some health insurance plans may cover some of the costs of trial participation.
Some aspects of your cancer care or other healthcare may not be covered by the clinical trial. For example, the costs of medical appointments, treatments, or tests that you get outside of the trial will likely not be covered by trial funding.
Some clinical trials pay participants for taking part, but not all do.
Support during a clinical trial
If you decide to take part in a clinical trial, let a member of the research team know if you have any questions or concerns about the study or changes to your health during the trial.
You can also talk with your doctor or other members of your cancer care team about questions or concerns that you have about a clinical trial or changes to your health.
What happens after the trial ends
After researchers have collected data from clinical trial participants, they sort and analyze the data and interpret and summarize the results.
They may share clinical trial results by:
- publishing them in peer-reviewed scientific journals
- presenting them at research conferences, symposia, or meetings
- posting information about them online at ClinicalTrials.gov or other websites
Let a member of the research team know if you’re interested in getting information about the results and conclusions after the trial has finished.
If the results show that a treatment or intervention isn’t safe or effective, researchers may decide not to study it anymore.
If the results show that it’s safe and effective, researchers may study it further in another clinical trial phase.
If they have enough data showing that it’s safe and effective, they may submit the data to the FDA to get approval for the treatment or device that they studied. This allows manufacturers to market the treatment or device outside the study and may change how healthcare professionals manage lung cancer.
If you get a treatment or other intervention during a clinical trial, you may or may not be able to continue getting it after the trial has finished. Talk with the research team to learn whether you can continue to receive it after the trial is complete.
Sometimes the researchers may ask you to attend follow-up appointments to check for long-term benefits or side effects of the intervention or learn how you’re doing.
Clinical trials allow researchers to study new approaches for preventing, detecting, and treating health conditions such as lung cancer.
There are different types and phases of clinical trials, which have different goals and methods. It’s important to learn what a trial will involve before you sign up for it.
Consider asking your doctor whether they recommend any clinical trials for you. You can also learn about upcoming and current trials by searching the National Cancer Institute or ClinicalTrials.gov database online.
Your doctor or a member of the research team that’s conducting the trial can share information to help you learn what the trial will involve, including the potential benefits and risks of taking part. They can also help you learn whether you meet the eligibility criteria.
You have the right to withdraw from a clinical trial at any time, for any reason.
The results of a clinical trial may help experts improve lung cancer care.