A clinical trial is a research study to determine whether a new drug, combination of drugs, procedure or medical device is safe and effective. Sometimes clinical trials explore different ways of using treatments to make them more effective, easier to use and/or decrease side effects. Clinical trials may also be done to learn how to best use a treatment in a specific group of people.

• Treatment Studies – Test new or different approaches to treatment.
• Prevention Studies – Focus on preventing disease or stopping diseases from returning.
• Diagnostic Studies – Identify new and improved tests or new procedures for diagnosing particular diseases or conditions.
• Screening Studies – Test to find the best ways to detect diseases or conditions.
• Quality of Life Studies – Evaluate the effects of treatments on comfort and quality of life.
• Post-Surveillance Studies – Follow the effects of an approved therapy after widespread use.

Clinical trials offer access to the latest treatments in development, with personalized care at no cost (many even compensate participants for time and travel). Many participants report that they feel like they are making a difference by contributing to research in their condition and paving the way for better treatment and care for patients in the future.

It’s important to remember that the drugs being evaluated in clinical trials have not yet been approved by the Food and Drug Administration (FDA). This means that there is a risk that the potential treatment might not work as anticipated, or you may experience unexpected side effects. It’s important to weigh these risks against the benefits of being in a trial, and talk to your doctor and the study team about your decision.

Every clinical study has strict guidelines about who can and cannot participate. This is done in order to maintain the integrity of the research. These guidelines spell out requirements, which are often called eligibility criteria; if someone meets those requirements, he or she is considered “eligible” for the study and may move forward with enrolling. Similarly, many studies also list ineligibility criteria, which lists the requirements that would disqualify a someone from a trial.

A clinical trial often tests a potential new treatment versus a control, which can be a placebo. It is important to know that on a clinical trial you will not receive less treatment than the ‘standard of care’ or what is considered current best practice. Even in trials where a placebo or inactive medicine is being used as the control to compare to a new treatment, that placebo is being given with the standard of care. It’s important to talk to the study team before the trial to make sure you understand what the trial is testing and what options you may be given.

Be sure to talk to you doctor at your next appointment, as he or she may be a good resource. But keep in mind that many doctors are so busy caring for patients that they may not be aware of the latest research options. You can also look online to find a trial that is right for you. This could include connecting with fellow patients on social media, reaching out to advocacy groups, or using our online clinical trial search tool, powered by Antidote.

Once you’ve found some trials for which you are likely eligible, it can be hard to figure out which is the most promising and the best for you. You’ll want to know if the treatment has been studied before and what the results have been, as well as what phase each potential trial is in. You can call our Treatment and Trial Navigators at 1-800-298-2436 to discuss the options. Online research is also a great tool to learn more about the drugs being studied in the trials to which you’ve matched. Social media can be helpful, too, to see if other patients are talking about experiences they’ve had with the respective drugs. And of course, you can always bring your trial list to your next doctor’s appointment; he or she will likely have a good sense of what trial might be the best choice for you.

In addition to the drug being studied, you should think about the logistics of the trials you’re considering. Will you be able to get to appointments? Will you be compensated for time and/or travel? Will there be procedures used that are not acceptable to you? Considering these details can help you narrow down your selection, as well.

Once you’ve gone through the process of selecting the trial that may be best for you, you’ll need to go through the enrollment process:

1. Contact the researcher running the study, either by email or by phone. This information is usually available online, or if you use a search tool such as the one on our site (powered by Antidote), that information will be included in your results.
2. Shortly thereafter, you’ll be contacted by the researchers running the study so that they can ask you a few more questions and determine whether you are likely a good match for the study. If you are, the next step will be to go to the study site to meet the team conducting the study and answer additional questions.
3. If you are indeed a match for the trial you’re interested in, you’ll then begin the informed consent process. This means that the study team will walk you through all of the details of the trial. You’ll learn about its purpose, how long it will run, the general schedule, what is expected of volunteers, and potential risks and benefits. This is when you can ask any questions you have, as well. If after learning more, you’d still like to participate, you’ll then sign an informed consent form that lays out all of the details that the study team shared with you.
4. Remember that even after you’ve signed an informed consent form, you are allowed to leave the trial at any time.

Informed consent means that all of the important details about a trial have been shared with a volunteer before he or she enrolls. An informed consent form is a document that lays out all of the information about a trial, including the purpose, risks and benefits, and logistics. It will detail exactly what the trial team expects from volunteers, and what volunteers can expect, as well. If you’re going to take part in a trial, you’ll need to sign this form to indicate that you have been given all of the details of the trial and have made the decision to enroll with all the appropriate knowledge.

When you take part in a study, you are a volunteer. This means you can leave at any time, for any reason. You do not need to stay in the trial if you don’t want to.

Yes, during the course of the trial, you can and should continue to see your regular doctor for any healthcare needs outside of the trial.

If something goes wrong during a trial (such as a serious adverse reaction, or the drug not working as anticipated), the researchers conducting the study are responsible for addressing the issue. If you have any questions or concerns, you should definitely bring them up during your clinical trial appointments. And remember, you can leave a study at any time, for any reason.

This varies from study to study and from drug to drug. Sometimes, volunteers will be given access to the study drug following the trial. This is a great question to ask during the informed consent conversation.

While we believe that patients should have access to results of any trial for which they volunteer, unfortunately this is not always the case. This is another important topic to bring up during your informed consent discussion. Ensure that you are comfortable with how results will be shared with participants before enrolling.