At Temple, hundreds of students, employees and members of the community volunteer for clinical trials every year, to further research on some of the most important health issues today, including diabetes, obesity and, most recently, smoking cessation.

At any given time, Temple may have more than 200 clinical trials running, coordinated through the Office of Clinical Trials and the Office of Sponsored Projects, both part of the Office of the Vice President for Research and Strategic Initiatives.

These clinical trials evaluate potential new drugs, devices and behavioral therapies. Volunteers involved in the human-subject phase of these trials may swallow a pill that will take pictures of their digestive tract, have their balance checked in virtual reality, or try a new antibiotic that may help them breathe easier.

“By voluntarily signing up for clinical trials, participants can help forward research that can lead to discoveries that will improve the quality of life for many individuals,” said Richard Throm, director of the Office for Human Subject Protections and Institutional Review Board Coordinator at Temple.

Fit to Quit* is one such trial, led by Melissa Napolitano, Ph.D., clinical psychologist at the Center for Obesity Research and Education and associate professor of kinesiology at the College of Health Professions. Focusing on college-age women, researchers are studying how exercise or body-image counseling sessions might help young women kick their smoking habit for good. They hope that their program will combat the trend of relapse among young women, many who report lighting up again due to weight gain and weight concerns.

Second-year Temple student Sarah Mumper was looking for a proactive way to quit smoking when her roommate saw a flier posted in Anderson Hall, and immediately told Mumper. She called the number on the ad, and began attending program-sponsored exercise classes at Pearson Hall, while using a nicotine patch.

Mumper admitted that while she did quit in the fall, during the holiday break she fell back into old smoking habits — but she has already set another quit date. She added that the program helped her to make better choices in her diet and exercise, so that she was able to maintain her weight after quitting.

“I wanted to get healthy, and I think the structured program was a big help for me,” Mumper said. “The motivation and support were a help, not only for the smoking, but they helped me improve my diet and exercise routine.”

Since Fit to Quit clinical trial began in the spring of 2007, about 14 volunteers have taken part in the study. But, as in most research studies for health-related programs and products, they need a significant number of subjects to show conclusively that the program works.

Human-subject testing is required before any drug can be approved by the Food and Drug Administration for public availability, and is critical in finding out how different medical approaches work in humans. In fields such as psychology, human testing is essential in learning about behavioral and mental patterns.

Before the start of any clinical trial, researchers must submit a research protocol, or study outline, for review by an Institutional Review Board. Once the trial has been approved, researchers can begin recruiting participants, all of whom must provide “informed consent”** before taking part. Once the trial begins, researchers follow strict federal guidelines and ethical procedures. Every clinical trial is subject to federal oversight, and study findings must be reported to the public and government agencies like the FDA or the National Institutes of Health.

Over the years, study volunteers have helped Temple researchers identify early warning signs of potential pregnancy danger, improve attention deficit hyperactivity disorder (ADHD), and recognize the presence of language skills in very young children, among many other discoveries.

Napolitano, like Throm, believes that volunteer participation is essential to finding appropriate, evidence-based treatments that work.

“We are particularly grateful for the time and effort our Fit to Quit participants have devoted to this research study. It is through their participation that we collect evidence about the success of our programs and ultimately find programs that help people live healthier lives,” she said.

Mumper added that working closely with medical professionals gave her the feeling of having a team of experts in her corner.

“Doctors are there to guide you and provide you with the tools you need to succeed,” Mumper said. “And as participants, we’re able to give them the feedback that will improve the program and hopefully help more women quit in the future.”

For more information on Temple’s current clinical trials, visit www.temple.edu/ovpr/oct. A list of studies currently recruiting subjects is also published in the last Temple Times issue of every month, in a column called Study Volunteers. If you are a Temple researcher who wants a trial included in the Study Volunteers column, contact Editor Betsy Winter Hall at betsy.winter@temple.edu. For more information on Fit to Quit, contact research assistants Alia Tanko at 215-707-8650 or atanko@temple.edu, or Dominique Ruggieri at 215-707-5320 or dgr@temple.edu.

* This research study has been reviewed and approved by the Temple University Institutional Review Board and is assigned IRB Protocol #11193.

** Informed consent is the process by which potential volunteers decide whether or not to participate in the trial. Researchers explain the details of the study, and provide an informed consent document which outlines the purpose, duration, required procedures, and key contacts for the study, and lists potential risks and benefits. Informed consent continues throughout the study as researchers consistently provide information to study participants. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

– ClinicalTrials.gov, a service of the National Institutes of Health.