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URMC / Patients & Families / Health Matters / September 2016 / Myth Buster: The Truth About Clinical Trials

Myth Buster: The Truth About Clinical Trials

Whether it’s a new drug, medical device, or behavioral intervention, careful testing is needed to ensure health innovations are safe and effective. UR research expert Dr. Carrie Dykes shares facts about clinical trials and their important role in advancing health care.senior gentlemen consulting with a medical professional

Clinical trials are tightly regulated studies that help scientists understand new and better ways to heal people and prevent illnesses. Volunteers are an essential part of this research; a lack of willing volunteers can decrease the impact of a clinical trial or prevent it from happening at all. And diversity in clinical trial volunteers is important since certain diseases—and their treatments—may have different effects based on a person’s gender, race or ethnicity.

Some people shy away from volunteering for clinical trials out of fear. Let’s clear up some myths so you’ll have the facts if you’re faced with an opportunity to participate in one.

Myth: Clinical trials are only for very sick patients with no other treatment options.

Fact: Clinical trials study health issues of varying severity and enroll volunteers with varying levels of health. Some clinical trials are conducted in patient volunteers who have a known health issue that the study aims to treat and many trials require healthy volunteers. Healthy volunteers do not have the health issue being studied (although they may have other unrelated ailments). Both groups—healthy and patient volunteers—get the same carefully planned treatments and are compared to one another to gauge how well those treatments worked.

Myth: If I’m healthy, being in a clinical trial won’t benefit me.

Fact: It’s true that most clinical trials may not benefit healthy volunteers directly (though some offer compensation or free physical exams). However, many volunteers feel rewarded by the opportunity to help others and to further medical knowledge.

Myth: Clinical trials are dangerous.

Fact: While studies have stringent safeguards, there are both risks and benefits and they vary from study to study and from volunteer to volunteer. Volunteers should carefully weigh these when considering participation in a clinical trial and discuss them with their doctor and the study team.
Many risks are avoidable and clinical trial volunteers are protected by federal and local regulations.

  • Doctors, researchers and community members extensively review and monitor trials to protect participant rights and ensure ethical practices.
  • Doctors or study teams must educate volunteers about the study, how it may affect them, and what the risks and benefits are, so they may give informed consent before enrolling in a trial.
  • Any information that may identify volunteers is kept private and protected and can only be shared with volunteers’ written permission.

Myth: If I start a clinical trial, I cannot back out.

Fact: Clinical trial participation is completely voluntary. If you enroll in a study, you have the right to withdraw from it at any time, for any reason, with no penalty or negative impact on the clinical care provided by your doctor. Doctors or researchers may also withdraw volunteers from a clinical trial if they feel it is no longer in a volunteer’s best interest. In this case, the volunteer must be told why they were withdrawn from the study.

Myth: My doctor will tell me if I’m eligible for a clinical trial.

Fact: While researchers do their best to inform doctors about clinical trials, not all doctors will know about all of the potential clinical trials that may be available to you.

Here are some helpful resources to help you find clinical trials:

  • RocHealthResearch.URMC.edu, the University of Rochester Clinical and Translational Science Institute’s Health Research website, offers information on trials conducted locally. You can search open clinical studies, join local and national research volunteer registries, and sign up to be contacted for more information about a study. You can also sign up for our local research volunteer registry to learn about studies that might interest you, with no obligation to participate in any studies.
  • ResearchMatch is a national registry where you can search for clinical studies and can join the national research volunteer registry, without obligation to participate in any studies.
  • Clinicaltrials.gov, hosted by the National Institutes of Health, lists clinical trials happening around the country. For help navigating the site, visit their helpful page on how to find clinical trials.

 

Carrie Dykes, Ph.D.

 

Carrie Dykes, Ph.D., is the research engagement specialist at the Clinical and Translational Science Institute at the University of Rochester.


 

Lori Barrette | 9/1/2016

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