Clinical Trials 101 FAQ

Why should I consider a clinical trial?

There are many reasons that patients choose to participate, and it’s important to make your decision carefully. If you participate in a trial, you may receive access to the latest treatments in development, and more personalized care provided at no cost. Some trials compensate participants for time and/or travel. In addition, many patients who take part in research report that they feel as if they are making a difference by contributing to science and paving the way for better treatment and care for their condition in the future.

Are there are risks involved with taking part in a trial?

The drugs being tested in clinical trials have not yet been approved by the FDA, which means there is a risk that the potential treatment might not work as expected, or you may experience unanticipated side effects. It’s important to weigh the risks against the benefits of joining a trial. Talking to your doctor and the team running the study can help you consider your options and make a decision.

What are eligibility criteria?

As part of the scientific process, every clinical trial has guidelines about who can and cannot participate. These guidelines are strict and cannot be bypassed as they allow the integrity of the research to be maintained. They provide specific requirements, also known as eligibility criteria, which determine who can and cannot take part in a trial. If someone meets the requirements, they are considered “eligible” and may enroll in the trial. Many trials also include ineligibility criteria, which are requirements that would cause someone to be ineligible for, or disqualified from, the trial.

Will I be given a placebo in a clinical trial?

Clinical trials test a potential new treatment versus a control; this is part of the scientific process and allows researchers to determine how the new treatment is working. The control can be a placebo, meaning that the trial participants will not be given the treatment (a sugar pill or similar may replace the treatment being studied). The control may also be the standard of care, meaning that the trial participants will be given the treatment that considered current best practice for their condition. For many severe or life-threatening conditions, clinical trial participants would never receive a placebo. Before you enroll in a trial, make sure you ask the study team about the chances you may receive a placebo.

How can I find a clinical trial that is right for me?

With thousands of trials available, finding one for which you qualify can be difficult. Talk to your physician at your next appointment — doctors are a good resource and may be able to help you determine which trials may be right for you. However, some doctors are strapped for time and unable to keep up with the latest research options. In this case, you may want to search online to find a trial that is right for you. Connect with fellow patients on social media to find out what trials they have taken part in, reach out to advocacy groups, or use services such as Antidote, which powers the EDS Wellness clinical trial search and helps you find your trial matches with just a few clicks.

If I am eligible for several trials, how do I decide which might be the best option for me?

Once you’ve done the hard work of finding trials for which you may qualify, it can be difficult to determine what is the most promising and best option for you. Conduct online research to learn about the drugs being studied in your trial matches — find out if they’ve been studied before, what the results have been, and what phase ach potential trial is in. You can also look to social media to see what other patients have to say about their experiences with the drugs being studied in the trials you are considering. And of course, you can always bring your potential trials to your doctor; they know you best and will have a good sense of what might be the right choice for you.

Beyond the drug being studied, when considering a clinical trial, you should also think about the logistics of each trial. Will the appointment schedule work for you? Will you be paid for time, travel, or both? Are you okay with the procedures that will be used? Thinking through these details can help you narrow down your choices as well.

What is the process to get involved in a clinical trial?

Once you’ve chosen which trial you think is best for you, you can start the enrollment process. There are a few steps to ensure that you are fully informed about the trial before you enroll.:

  1. Get in touch with the researcher running the trial. Contact information (either phone or email) is usually available online. If you use our search tool powered by Antidote, you can find researcher contact information in your list of results.
  2. The researchers will respond and likely ask you a few more questions to figure out if the trial is the right match for you, and vice versa. If the trial sounds like a good fit, the next step will be to attend an appointment at the study site to meet the research team and answer a few more questions.
  3. If you are indeed eligible for the trial, you’ll then begin the informed consent process. Essentially, this means that the study team will provide you with all of the details of the trial, and you can ask any questions you’d like. You’ll learn about the trial’s purpose, how long it will run, what the schedule will look like, what is expected of participants, and potential risks and benefits. Use this time to also ask any questions you may have. Once you feel like you fully understand what it will mean to take part in the trial and have had all your questions and concerns addressed, you’ll sign an informed consent form.
  4. Of course, you can leave a trial at any time — even after you’ve signed an informed consent form. 

What do you mean by informed consent?

Informed consent is in place so that clinical trial participants know exactly what they are getting into before enrolling in a trial. An informed consent form details all of the information about a trial, including the purpose, risks and benefits, and logistics. It will lay out what the trial team expects from participants, and what participants can expect too. By signing this form, you’re indicating that you understand all of the details of the trial and have made the choice to enroll armed with any and all appropriate knowledge.

Can I continue to see my regular doctor after I join a clinical trial?

Yes, throughout the study, you can and should still see your regular physician for any healthcare needs outside of the trial.

What happens if something goes wrong during the study?

If something goes wrong during a trial (such as a serious adverse reaction, or the drug not working as expected), the researchers conducting the study will address the issue. If you are concerned about anything involving the trial, you should bring it to the researchers’ attention as soon as you can. And don’t forget, you can leave a trial at any time, for any reason.

Do I have to stay in a clinical trial after I’ve enrolled?

When you join in a clinical trial, you do so on a volunteer basis. This means you can make the decision to exit the trial at any time, for any reason. If you’d like to drop out at any point, you absolutely can.

Will I be able to continue taking the study drug after the study is over?

This is an important question, and the answer varies from trial to trial and from drug to drug. Sometimes, volunteers will be able to continue taking the study drug after the trial is complete. Make sure you ask about this during your informed consent conversation so that you know what to expect at the end of the trial.

Will I have access to the trial results? Will they be made public?

While we believe that patients should be able to access the results of any study in which they take part, unfortunately this is not always the case. This is another important question to ask the researchers during your informed consent discussion so that you can ensure that you are comfortable with how results will be shared prior to joining the trial.

Clinical Trials 101 FAQ written & posted with permission by Antidote – an EDS Wellness Collaborative Partner

Clinical Trials

If you or a loved one are living with EDS, you likely know how difficult it can be to decide on treatment or trial options. Today, we’re thrilled to share that we’ve launched a brand new clinical trial search tool (link out to widget) in partnership with Antidote to make finding and taking part in medical research easier than it’s ever been before. 

Why is medical research so critical? <INSERT SOME STATS/INFO RE EDS> Research is needed to address this, but in order for clinical trials to take place, patients need to volunteer to take part. Are you in?

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