Healthy Participant Raises Awareness for Importance of Clinical Trials

cmv_brittanyBrittany Robinson of Suwanee, GA, recently spent eight days and nights at Emory University Hospital, but she was not sick. To some people, spending over a week away from her husband and five children may seem crazy, but for Brittany, it was a personal way to give back and say thank you to the hospital that helped her son, Ethan.

Ethan was diagnosed at birth with the heart defect Wolff-Parkinson-White (WPW) syndrome with Ebstein’s anomaly, and was treated at Emory-Children’s Center. “My son was on medication from nine months old until last year. If there wasn’t someone doing this for him, for his heart medication, who knows what would have happened,” said Robinson. The medicine prescribed to Ethan went through the same process rigorous clinical trials process that all new drugs must go through.

It was this realization that prompted Brittany to enroll in an in-patient research study (A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of MBX-400 in Healthy Volunteers), testing the oral medication MBX-400 to treat cytomegalovirus (CMV) infection.

CMV is a common virus that can infect the majority of the population but can cause severe eye, neurologic, and organ diseases in patients with a weakened immune system. The oral and IV medications currently used to treat CMV have limitations and many scientists are stepping up to help find a new treatment. The study’s enrollment criteria requires only healthy people can enroll.

Allison Beck, PA, Mari Hart, RN, Nadine Rouphael, MD, and a team of Research Coordinators with the Hope Clinic have been recruiting for months to fully enroll this trial. Their struggle is common for clinical trial recruitment. People are hesitant because they do not want to be a “guinea pig” or are too busy to interrupt their normal routine though most studies provide compensation for time and travel. Unfortunately, people like Brittany who’ve relied on the medical field to save their loved ones usually do not make the incredible connection she made. This study is still enrolling and only has half the participants needed to complete the trial.

“Without research, we do not have the treatments and cures that save our loved ones. New medicines and vaccines that work and are safe are only discovered when heroes like Brittany and her family are willing to give their time to research and enroll in a study,” said study PI Mark Mulligan, MD, distinguished professor, Department of Medicine and executive director, Hope Clinic of the Emory Vaccine Center, Emory University. While Brittany may never know anyone with CMV, she is helping to give better treatments to those who are ill.

Every medication, treatment, or medical device currently available was FDA mandated to go through this process to prove safety and efficacy. This pipeline of new treatments and cures stops if trials cannot find participants. Clinical trials close and treatments and cures never make it to those who are ill.

After eight days at Emory University Hospital, Robinson says she feels better than ever and is more in-touch with her overall health. “The experience has been wonderful. I was actually very nervous going into it. I’ve never been away from my family for this long before. But I feel better, because you have to do a fast, can have no alcohol or caffeine, and I’ve actually gotten sleep. I feel refreshed, like a paid vacation,” said Robinson. The in-patient trial provides all meals, a room with a view, and the quiet needed for adequate rest. Something Robinson says she has not had since her first son was born eight years ago.

The Emory Hope Clinic needs more volunteer participants for this study and others. More information is available at www.hopeclinic.emory.edu and by calling 404-712-1371. The study is conducted by Emory’s Vaccine and Treatment Evaluation Unit (VTEU) funded by the U.S. National Institutes of Health (NIH).

RESOURCES
Read Brittany’s full story here
ACTSI
Clinical Trials at Emory

cta-clinical-trials

Tags: , , , , ,