Clinical Trials

Clinical Trials: Leading the Way to Better Health Care

Emory Clinical TrialsAs the leading academic medical center in Georgia, Emory Healthcare is home to researchers and physicians who are pioneering or participating in thousands of clinical trials across the nation.

The discovery that comes from these research studies not only makes a different in the way health care is delivered, here and now, but impacts patient care for generations to come.

A recent Atlanta Business Chronicle article highlights twenty clinical trials across the state of Georgia that have the potential to make a big difference in health care. 15 out of the 20 trials identified are Emory-led or Emory-involved clinical trials.

Learn more about clinical trials at Emory Healthcare, or click to find an Emory clinical trial.

Also, make sure to read below to see the Atlanta Business Chronicle’s list of promising trials to keep and eye on.

  • LEUKEMIA CLINICAL TRIAL

    • Principal investigator: Dr. Anand Jillella, professor of Hematology and Medical Oncology at Emory University’s School of Medicine; associate director for Community Outreach at Emory University’s Winship Cancer Institute
    • Location: Winship Cancer Institute, Emory University
    • Summary: Currently, one-third of patients diagnosed with Acute Promyeloctic Leukemia don’t survive the third month of treatment. By simplifying patient care strategies, Jillella and his team claim they have found a way to decrease this mortality rate from 30 percent to less than 5 percent. Winship is heading a national clinical trial.
  • LUNG CANCER CLINICAL TRIAL

    • Principal investigator: Dr. Suresh Ramalingam, professor of hematology and medical oncology, Emory University School of Medicine; director of medical oncology and the lung cancer program at Winship Cancer Institute
    • Location: Winship Cancer Institute
    • Summary: This study compares three different approaches to treating patients with certain forms of lung cancer after receiving chemotherapy. The national study will include a total of 1,495 participants, more than 1,400 of which have already been enrolled.
  • GRAFT VS. HOST DISEASE CLINICAL TRIAL

    • Principal investigator: Dr. Muna Qayed, assistant professor of pediatric bone marrow transplantation at Emory School of Medicine; physician, pediatric hematology and oncology, Children’s Healthcare of Atlanta; Jacques Galipeau, study sponsor, director of the Emory Personalized Immunotherapy Center, which manufactures cells using a unique processing technique
    • Location: Emory University School of Medicine, Children’s Healthcare of Atlanta, and Emory Personalized Immunotherapy Center (EPIC)
    • Summary: Qayed’s team is in Phase I of a trial that will test personalized cell therapy for the treatment of graft-versus-host disease (GVHD), a life threatening complication that affects anywhere from 30 to 70 percent of patients who undergo bone marrow transplantation. For patients who don’t respond to the first-line therapy (steroids) the disease can be fatal up to half the time. The study involves removing the participant’s own stem cells, manufacturing more of those cells and then infusing them back into participants.
  • BREAST CANCER CLINICAL TRIAL

    • Principal investigator: Dr. Wendy Painter, CEO of Que Oncology
    • Location: Que Oncology, a biotechnology company formed by Emory University and Brisbane, Australia-based UniQuest, the University of Queensland’s commercialization company, in partnership with Morehouse School of Medicine
    • Summary: This study aims to treat hot flashes in women receiving anti-estrogen therapy for breast cancer with Q-122, Que Oncology’s lead compound. Nearly 60 percent of participants experienced a reduction in hot flashes during Phase I of the study, which wrapped in November 2014.
  • CROHN’S DISEASE CLINICAL TRIAL

    • Principal investigator: Dr. Subra Kugathasan, Marcus professor of pediatric gastroenterology at Emory School of Medicine; physician, Children’s Healthcare of Atlanta
    • Location: Emory University School of Medicine, Children’s Healthcare of Atlanta and Emory Personalized Immunotherapy Center (EPIC)
    • Summary: Physician-researchers at Emory University and Children’s Healthcare of Atlanta are using “personalized” cellular therapy to treat older adolescents and adults suffering from Crohn’s disease by harvesting participants’ own marrow cells and manufacturing personalized ones to target the disease’s inflammatory mechanisms, potentially reducing intestinal flare-ups and minimizing long-term damage.
  • EBOLA CLINICAL TRIAL

    • Principal investigator: Dr. Anne Winkler and Dr. Colleen Kraft, assistant professors in pathology and laboratory medicine at Emory University School of Medicine
    • Location: Emory University Hospital
    • Summary: Investigators are collecting plasma from U.S. Ebola survivors to see if it could possibly prove effective when used in conjunction with standard treatment methods. Following the donor apheresis procedure which removes the plasma component from the blood and returns red blood cells to the donor, the plasma is treated with a device called the Intercept Blood System to remove any potential pathogens. The plasma is stored with the aim of using its antibodies to neutralize the active virus in the recipient’s blood.
  • PANCREATIC CANCER CLINICAL TRIAL

    • Principal investigator: Dr. David Kooby, professor of surgery, Emory University School of Medicine; director of surgical oncology, Emory Saint Joseph’s Hospital
    • Location: Winship Cancer Institute
    • Summary: One of the challenges in pancreatic cancer surgery is ensuring the removal of the entire cancer, as cancer cells can extend beyond the actual mass into the nearby normal-appearing pancreas. This study uses a novel application of a well-studied dye called indocyanine green coupled with a pen-shaped detection device (SpectroPen). The dye leaks out of the small vessels around the tumor cells, and the pen can be used to measure this leaking dye to detect cancer in the surrounding pancreas. This can help surgeons achieve complete cancer removal in more patients and it can help pathologists assess the tumor tissue more thoroughly to improve staging and better guide treatment.
  • BLINDNESS CLINICAL TRIAL

    • Principal investigator: Dr. Stephen Yeh, associate professor of ophthalmology and director of the section of uveitis and vasculitis at Emory Eye Center is running the uveitis study; Dr. Andrew Hendrick, assistant professor of ophthalmology at Emory Eye Center is running the retinal vein occlusion study.
    • Location: Clearside Biomedical has eight trial sites across the U.S., including Emory University
    • Summary: Drug development company Clearside Biomedical is conducting a trial on a micro-injector platform technology that allows surgeons to deliver medicine to treat the leading causes of blindness directly into the retina, improving the drug’s effectiveness while reducing side effects that can occur when the drug enters other parts of the eye. Clearside is currently conducting a trial on of uveitis, inflammation associated with the back of the eye. It’s also running a Phase II study in retinal vein occlusion.
  • EBOLA VACCINES CLINICAL TRIAL

    • Principal investigator: N/A
    • Location: GeoVax in Smyrna, Ga.
    • Summary: This tiny biotech company, of which Emory University is the single largest shareholder, is developing a second-generation preventive vaccine against the three strains of the Ebola virus. CEO Bob McNally said the goal is to have the vaccine ready for Phase I testing by next year in preparation for the next outbreak of the disease.
  • ALZHEIMER’S DISEASE CLINICAL TRIAL

    • Principal investigator: Dr. Ihab Hajjar, associate professor of medicine, Emory University School of Medicine
    • Location: Emory University
    • Summary: Hajjar’s team is conducting a one-year study (Calibrex) of the relationship between high blood pressure and Alzheimer’s disease. They will try to determine whether drug treatment for high blood pressure can affect those factors associated with Alzheimer’s disease. Eligible participants are older than 60, hypertensive, and have mild cognitive impairment.
  • HIGH BLOOD PRESSURE CLINICAL TRIAL

    • Principal investigator: Dr. Chandan Devireddy, associate professor of medicine, Emory University School of Medicine
    • Location: Emory University
    • Summary: In August 2013, Emory was the first in the world to implant a MobiusHD device, a catheter-delivered implant that can help lower high blood pressure without the use of medication. It is one of nine centers in the United States conducting a study to evaluate the device and how it compares to standard treatments for people with treatment-resistant high blood pressure.
  • HEART FAILURE CLINICAL TRIAL

    • National co-principal investigator: Dr. Vinod Thourani, professor of surgery, Division of Cardiothoracic Surgery, Emory School of Medicine; chief of cardiothoracic surgery, Emory Hospital Midtown, co-director, Structural Heart and Valve Center
    • Emory investigator: Dr. Vasilis Babaliaros, associate professor of medicine, Emory School of Medicine, co-director, Structural Heart and Valve Center.
    • Location: Emory University
    • Summary: Emory is now enrolling qualified patients for its Partner II Sapien 3 trial for aortic valve replacements, a groundbreaking nonsurgical treatment for patients with failing aortic valves who are considered intermediate risk for surgical therapy. Emory was the first center in the Southeast to place a Sapien valve in a patient without opening the chest and the first in the U.S. to implant the newest generation Sapien 3 valve. It is one of the largest enrolling centers for the national clinical trial to evaluate this latest generation of transcatheter aortic valves.
  • CANCER PAIN CLINICAL TRIAL

    • Principal investigators: Dr. Mark Rapaport, Reunette W. Harris professor and chair of the Department of Psychiatry and Behavioral Sciences at Emory University School of Medicine, and chief of psychiatric services, Emory Healthcare; and lead investigator, Dr. Mylin Torres, associate professor in Emory University’s Department of Radiation Oncology
    • Location: The Emory Brain Health Center, Department of Psychiatry and Behavioral Sciences
    • Summary: Previous research conducted by Rapaport has shown that massage therapy can boost the immune system and decrease anxiety for people who do not have cancer. In this study, the researchers are investigating the effects of massage on the debilitating fatigue post-surgery cancer patients experience as a result of chemotherapy, chemo-prevention and/or radiation.
  • DEPRESSION CLINICAL TRIAL

    • Principal investigator: Dr. Helen Mayberg, professor of psychiatry and neurology at Emory University School of Medicine, and Dorothy C. Fuqua Chair in Psychiatric Neuroimaging and Therapeutics
    • Location: Emory University School of Medicine
    • Summary: Mayberg leads a team of researchers studying the results of implanting electrodes into a pinpointed region of the brain believed to be responsible for regulating depression in some people. The electrodes send electrical impulses to interrupt faulty brain circuits in that portion of the brain. The study targets patients whose depression has resisted treatment by any other means. Various phases of clinical trials have been ongoing since 2003. Subsequent trials on patients with unipolar and bipolar depression have shown promising results.
  • ALZHEIMER’S CLINICAL TRIAL

    • Principal investigator: Whitney Wharton, assistant professor of neurology, Emory University School of Medicine
    • Location: Emory University
    • Summary: Wharton’s team is studying the effects of blood flow on factors that contribute to Alzheimer’s disease. Participants come to the university once annually for cognitive assessments, blood pressure monitoring, vascular ultrasounds and lumbar puncture.

Related Resources

Find an Emory Trial
Clinical Trials – FAQs
Understanding Clinical Trials – Part 1: What are Clinical Trials?

Understanding Clinical Trials – Part 1: What are Clinical Trials?

What is a Clinical Trial

WATCH Winship at Emory patient and clinical trial participant, Holly Johnston, discuss her decision to enroll in a cancer clinical trial.

Clinical trials are an essential part of moving research forward and most medical advances have been made possible because of volunteer participation in clinical trials.

At Emory Healthcare, clinical trials are at the core of our mission where discovery and research fuel exceptional patient-and-family-centered care. But for many people, clinical studies seem complicated and intimidating. To answer some popular questions about clinical trials and clear up common misunderstandings, we are launching a six-part series on understanding clinical trials and why they are an important part of patient care.

What are clinical trials?

A clinical trial is a form of research that uses human volunteers (called participants) to answer specific questions that help doctors understand new ways to prevent, diagnose and treat diseases.

Existing treatments today may not be effective for everyone, so clinical trials help determine if new drugs, diagnostics or procedures are safe and effective before they are made widely available. There are different types of clinical trials, but all start with a question. An example question would be “does the dose of this drug impact its effectiveness?” A well-designed clinical trial is set up to provide answers to the original question.

What happens during a clinical trial?

Every clinical trial is led by a principal investigator, who is usually a medical doctor, and they typically have a research team including doctors, nurses, social workers and other members of the care team. New treatment therapies are usually tested in three separate phases before regulatory agencies consider them safe and effective.

During a clinical trial, data is collected to help inform the study outcome, which can be positive or negative. Either way, a clinical study is successful if the answer to the initial question is clear and has a solid foundation of scientific data to support it. Even if the outcome is different than the principal investigator’s hypothesis, the end result informs which direction the research team should take next.

Clinical Trials at Emory

There are more than 1,000 clinical trials underway at Emory Healthcare and the outcomes are not only making a difference in people’s lives here and now, but for generations to come.

As we continue our blog series on understanding clinical trials, we want to know what questions you have about clinical trials and clinical research. Leave your questions in the comments field below and your question may just get answered by an Emory researcher!

Also, click to see a list of frequently asked questions about clinical trials.

Related Resources

Emory’s Stroke Rehabilitation Clinical Trial Chosen as Top International Trial

Rehab Clinical TrialAt Emory, clinical trials are at the core of our mission and we are proud to offer them to our patients. Groundbreaking scientific advances and medical treatments available today have been made possible because of volunteer participation in clinical trials and research.

In fact, one of the thousands of clinical trials conducted at Emory was just identified as one of the 15 top international clinical trials ever published for physical therapy and rehabilitation.

The EXCITE (Extremity Constraint-Induced Therapy Evaluation) trial, led by Emory University’s Steven Wolf, PhD, PT, professor of rehabilitation medicine at Emory University, was created to teach stroke patients to use their stroke-affected arm rather than their “good” arm. Conducted almost a decade ago, the clinical trial was found to have a significant impact in stroke rehabilitation, which set the stage for many future trials.

Each year, more than 795,000 people in the United States suffer from a stroke and many stroke survivors experience partial paralysis on one side of the body. The EXCITE trial enrolled 222 patients who had suffered a stroke, predominantly an ischemic stroke, within the previous three to nine months.

During the trial, participant’s less-impaired hand was restrained and/or immobilized by placing a mitt around the “good” arm in an effort to encourage use of the affected extremity. Participants engaged in daily repetitive tasks and behavioral therapy sessions, which included training in tasks such as opening a lock, turning a doorknob or pouring a drink. Only use of the affected arm was allowed during exercise.

“Often, stroke rehabilitation focuses on teaching patients how to better rely on their stronger limbs, even if they retain some use in the impaired limbs, creating a learned disuse,” says Wolf. “This trial was just the opposite and focused on the impaired limb, which proved to be a valuable form of rehabilitation. We are so pleased and honored that this clinical trial has been found to be a top 15 trial amongst an international jury of experts.”

Wolf, and other Emory University researchers partaking in the national trial, studied participants to determine if the intervention improved motor function, as compared to no therapy at all. Patients were evaluated using the Wolf Motor Function Test (named after Wolf), which is a measure of laboratory time, strength-based ability and quality of movement.

Research investigators found that over the course of a year from the beginning of therapy, the group undergoing constraint-induced therapy showed greater improvements than the control group in regaining function.

“Results showed that constraint-induced movement therapy produced statistically significant and clinically relevant improvements in arm motor function that persisted for at least one year at follow-up,” says Wolf. “This trial was the first large multi-center, randomized controlled trial in stroke rehabilitation that lay the ground work for many other trials to follow.”

The EXCITE trial was funded by the National Institutes of Health from 2000-2005 and the results were published in JAMA in 2006. For the past 15 years, PEDro, a database located and supported within the George Institute for Global Health in Australia, has reviewed clinical trials, guidelines and reviews of work related to rehabilitation and physical therapy. During that time period, around 28,000 trials and manuscripts dating back as far as 1929 were reviewed. The free database is used by thousands of physiotherapists and others interested in rehabilitation from more than 200 countries. Out of the 15 trials highlighted by PEDro, only two were clinical trials based in the U.S.

Click to learn more about clinical trials at Emory, or call 404-778-7777.

Related Resources