Signing Up for a Clinical Trial

By:    Medically Reviewed: Tom Iarocci, MD   Published: February 21, 2014

Clinical trials test new treatments, strategies or devices and can save lives and advance medicine. Here’s how to find a good one to join.

a a a
Across the world, about 32,000 studies are in the active recruiting phase for a clinical trial, with investigators studying new treatments, strategies or devices. But for some, the idea of joining a clinical trial is just plain scary.

 

“People are often afraid they are going to be a guinea pig,” says James McGough, MD, professor of clinical psychiatry at the Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at the University of California, Los Angeles (UCLA). He is also chair of UCLA’s institutional review board in neurosciences and has been a principal investigator for many clinical trials.

 

But McGough is comforting. “There is an ethical responsibility in every clinical trial to be sure the patient is well cared for,” he says. “For many people, participation in a clinical trial is a means to get really good care.”

 

For some time, most states have had laws aimed at directing insurance companies not to “pull the rug out from under patients” if they decide to join a clinical trial. Under a provision of the Affordable Care Act, health insurers must cover routine patient costs associated with approved clinical trials. The rule applies to health plan periods beginning on or after Jan. 1, 2014.  

 

Defining and Finding a Clinical Trial

In a clinical trial, the first phase of study usually involves only healthy volunteers, McGough says. During phases II and III, the focus shifts to risks and benefits of the treatment, strategy or device, so people with the specific disease being studied are needed.

 

Studies involve a huge variety of ailments or conditions, including cancers, gastrointestinal problems, muscle diseases, lung problems and ear-nose-throat conditions. The trial leader is often a physician, typically with a team of health care professionals, including other doctors, nurses and social workers.

 

Monitoring of the clinical trial is constant. “If it seems any of the participants are at a particular disadvantage or they are likely to suffer harm, there are mechanisms to stop the trial,” McGough says.

 

Clinical trials are often held in hospitals, university centers, doctor’s offices or community clinics. Your doctor may refer you to a trial, or you can search for one at ClinicalTrials.gov, a service of the National Institutes of Health. At ClinicalTrials.gov, you can search by disease for institutions near your home, and the site offers contact information for recruiters, if you are interested in signing up for a particular trial. 

 

Weighing the Pros and Cons of Clinical Trials

The researchers will provide information about the study, including the objective; the potential risks and benefits of the trial; and the treatment alternatives. Before joining, you will need to sign an “informed consent” form, showing you understand the given information.  

 

There are risks with any clinical trial and with almost any drug or device — even those that have already made it through clinical trials and have been approved by the U.S. Food and Drug Administration. But the entire process of drug development is geared toward shining a bright light on potential risks, long before the first person ever swallows the investigational pill, gets the shot or receives the intervention.

 

“Being in the trial should not create any risks greater than standard treatment,” McGough says.

 

Depending on what is being studied, there is a chance you will get a placebo — a “sugar pill” — instead of the treatment. You need to decide if that’s acceptable, McGough says. For some conditions, such as baldness, it might be OK to receive a placebo, knowing if the treatment pans out, you can undergo treatment once publicly available. Only you can decide.

 

Next Steps 

Before making a final decision about joining a clinical trial, ensure you have the answers to important questions. For example, if the printed information isn’t enough, contact information should be provided with study descriptions.

 

Important questions for both potential clinical trial patients and their family caregivers include:

  • What is being studied?
  • What are the risks, side effects and benefits compared with my current treatment?
  • How often must I visit the study center?
  • How long will the study last?
  • Who pays for my participation, and will expenses be reimbursed?
More in Health A-Z
New on SymptomFind
a a a  
sources
  • McGough J., MD, professor of clinical psychiatry at the Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at the University of California, Los Angeles and chair of UCLA’s institutional review board in neurosciences. http://www.semel.ucla.edu/profile/james-mcgough. Interviewed January 2014.
  • National Institutes of Health. “What Are Clinical Trials?” Updated August 2012. http://www.nhlbi.nih.gov/health/health-topics/topics/clinicaltrials/. Accessed January 2014.
  • “Compilation of Patient Protection and Affordable Care Act.” May 1, 2010. http://housedocs.house.gov/energycommerce/ppacacon.pdf. Accessed January 2014.
  • ClinicalTrials.gov. “Learn About Clinical Studies.” Updated August 2012. http://clinicaltrials.gov/ct2/about-studies/learn. Accessed January 2014.
  • American Cancer Society. “Clinical Trials: State Laws About Insurance Coverage.” Updated February 2014. http://www.cancer.org/acs/groups/cid/documents/webcontent/002552-pdf.pdf. Accessed January 2014.
RELATED ARTICLES
NEED ANSWERS?