Posts Tagged ‘clinical trials’

New study uses cryoablation to reduce pain for cancer patients

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Kevin Makowski, RBP

A new study using cryoablation to decrease pain for patients who have cancer metastases in the bone is now underway throughout Emory Healthcare. Cryoablation is a process that uses extreme cold (cryo) to destroy or damage tissue (ablation).

Called the “Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases”, or MOTION, the study aims to assess the effectiveness and safety of cryoablation therapy to treat patients with painful bone metastases and document the effects the procedure has on their condition.

The prospective, single-arm study will enroll 60 participants at eight centers in the U.S. and internationally. Twenty participants can enroll at Emory Johns Creek Hospital, Emory University Hospital, Emory University Hospital Midtown, and Emory Saint Joseph’s Hospital. Participants will serve as their own control group in this one-year study.

The clinical trial examines self-reported pain scores from the patients. Investigators are assessing improvement in scores defined by more than a two-point reduction in the worst pain in the last 24 hours, using the Brief Pain Inventory (BPI), from before the cryoablation procedure to eight weeks after the procedure takes place. The trial will assess patients experiencing pain at a level of 4 or above on a scale of 0 (no pain) to 10 (unimaginable pain).

The goal is to freeze cancerous cells and stop the pain signals to the brain. We use image guidance to insert the ablation probe into the middle of a painful cancer lesion. Then, we create an ablation zone by lowering the temperature to minus 40 degrees centigrade for 10 minutes.

Emory interventional radiologists freeze tumors in order to kill cancer cells in contact with the bone and reduce the size of the tumor. CT images obtained during the procedure helps doctors guide needles into the tumor.

Cryoablation provides an alternative for patients who haven’t experienced relief from current pain therapies. Many patients suffering from cancer pain take several medications to cope with the pain.

The outpatient cryoablation procedure takes about an hour.

Galil Medical is funding this clinical trial.

For more information about this study, contact the study coordinator, Maria Rivas at 404-712-7962.

Learn more about other available trials.  http://clinicaltrials.emory.edu/

Dr. J. David Prologo

J. David Prologo, MDdavid_prologo_photo, is an assistant professor in the Department of Radiology and Imaging Sciences at Emory’s School of Medicine, and director of Interventional Radiology Services at EJCH. Prologo is the principal site investigator for the MOTION study, and one of 10 subspecialty trained, board certified interventional radiologists at Emory.

New Website Makes Searching For Emory Clinical Trials Easier

cthp-250x250We are thrilled to announce the launch of a new Emory clinical trials website! The new site – clinicaltrials.emory.edu – features easy-to-access information for nearly 1,000 active clinical trials at Emory that are currently seeking volunteers.

Potential clinical trial participants may easily search for trials related to a specific health condition or browse by topic areas such as cardiology, cancer, or neurosciences and view quick facts about each of the individual trials. While many clinical trials are seeking patients who have a particular disease, many others are seeking healthy volunteers.

“Emory’s ability to develop improved therapies through clinical research is a key component of our clinical mission and gives patients access to the most advanced treatments available,” says Jeffrey Lennox, MD, associate dean for clinical research in Emory University School of Medicine. “This new clinical trials website will allow more people within Emory and the broader community to learn about and participate in the wide range of available clinical trials.”

What Information Is Included On The New Website?

Each clinical trial listing includes information on its purpose, timing, key investigators, process, and eligibility criteria. For additional information, potential volunteers may click on a link to send a message the leader of each individual trial. Emory trials will continue to be listed in the National Institutes of Health (NIH) clinical trials database – clinicaltrials.gov– which provides more detailed information.

If you wish to learn more about clinical trials in general, the new website also includes frequently asked questions about volunteering, information on additional resources at Emory for potential participants, and NIH information about clinical trials.

The Value Of Clinical Trials

Medical advances and improvements to clinical care have been made possible the participation of volunteers in clinical trials. Some studies test new drugs or surgical procedures and devices, while others look for better ways to prevent diseases in people who have either never had a disease or are trying to prevent one from coming back. Other types of trials help find ways to improve the care and quality of life of people with long-term illnesses and diseases.

People choose to participate in clinical trials for a variety of reasons. Current patients may participate in order to receive care and potentially benefit from a new therapy. Healthy volunteers may participate in clinical trials to help current and future patients and to contribute to help researchers find better treatments.

For more information on clinical trials at Emory, please ask your Emory physician or call the Emory HealthConnection℠ at 404-778-7777.

 

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Emory-led clinical trial tests microneedle skin patches as alternative to flu shot

An example of a microneedle patch. Photo by Gary Meek, gatech.edu

An example of a microneedle patch. Photo by Gary Meek, gatech.edu

A clinical trial at Emory University is currently underway to test whether microneedle patches applied to the skin are a safe and effective alternative to conventional flu shots.

The patches, which are about the size of a quarter, contain very tiny (thin and short) needles, called microneedles, which are barely visible to the eye. Once the patch is applied to the skin, the microneedles begin to penetrate the upper layers of the skin and deliver the vaccine.

Researchers plan to enroll up to 100 participants in the clinical study conducted at the Hope Clinic of the Emory Vaccine Center. Volunteers must be healthy adults between ages 18 and 49 who did not receive a flu shot in the 2014-2015 season will receive either one dose of the regular flu shot or one patch containing either the flu vaccine or containing placebo.

The flu vaccine used in the study is the same as the FDA-approved flu vaccine from last season. The purpose of the study is to assess the safety of the microneedle patch, how the body’s immune system responds to the vaccine delivered through a patch, and participants’ opinions about using the patch. Participants will receive follow up, including blood work, during six visits over six months.

For more information about the microneedle clinical study, contact the Hope Clinic by phone at 404-712-1371, email at vaccine@emory.edu or click here.

For more information about clinical trials at Emory Healthcare, visit our clinical trials website and make sure to review the list of frequently asked questions.

Revolutionary Research Underway with First-in-Man Clinical Trial for Hunter Syndrome

Hunter SyndromeAs an academic medical center, many physicians at Emory not only take care of patients on a daily basis, but also partake in research and teaching/training the future generations of physicians.

It’s through discovery that happens during clinical trials and research that allows for new advancements in medicine to be made. Providing the standard of care of is not always enough. New treatment therapies, technology and care delivery techniques must be developed, tested and perfected in order to keep advancing health care.

Not sure what clinical trials are? Check out our blog post that explains Clinical Trails>>

 
Currently happening at Emory is the first-in-man clinical trial, testing a newly developed drug for a rare genetic condition called mucopolysaccharidosis type II (MPS II) or Hunter syndrome.

Hunter syndrome is a hereditary disease in which a critical enzyme is either missing, or there is not enough of it. Without enough of this enzyme, long chains of sugar molecules do not break down properly in the body and accumulate in the organs and tissues and become toxic.

To treat most cases of Hunter syndrome, an enzyme replacement medication is used, but this regimen does not cross into the brain to treat the most severe cases of Hunter syndrome. In this particular trial, Emory researchers are testing whether a man-made enzyme fused with an antibody and injected into the bloodstream will deliver the enzyme therapy into the brain. This is the first time this medication combination has been tested in a human.

The video below features Emory patient, Chris Dutcher. “By testing this new medication for the first time in a human, my hope is to help children with severe Hunter syndrome,” says Dutcher, whose younger brother also has the same disorder.

Chris has the mild version of Hunter syndrome, but his symptoms are still quite serious and involve the lining of the brain and spinal cord, which are not treated by existing medications. He is the first patient to receive the new treatment therapy.

More information about Hunter syndrome and this clinical trial can be found in the Emory News Center. Learn more about clinical trials at Emory Healthcare.

Related Resources

Understanding Clinical Trials – Part 4: What Questions Should You Ask Before Enrolling in a Clinical Trial?

Clinical Trials QuestionsParticipation in clinical trials is 100% voluntary. While there are many benefits to participating in clinical trials, there can also be risks. If you have been offered a clinical trial, or are considering participating, it is important to talk with your physician before enrolling in one. Your health care team wants to make sure you have all the information needed to make a decision.

Do not hesitate to ask any questions or bring up any issues concerning the trial with the research team associated with the clinical trial. Tips for asking about clinical trials include:

  • Take a family member or caregiver with you for support and for help in asking questions and recording answers.
  • Plan questions ahead of time — you can still ask new questions you think of while you’re there, but it helps to be prepared ahead of time.
  • Write down your questions in advance, to make sure you remember to ask them all.
  • Write down the answers, so that you can review them whenever you want.

The National Institutes of Health (NIH) developed a list of suggestions that may be helpful to review as you think about the questions you may have:

Questions about the Study

  • What is the purpose?
  • Why do researchers think the approach may be effective?
  • Who will fund the study?
  • Who has reviewed and approved the study?
  • How are study results and safety of participants being checked?
  • How long will the study last?
  • What will my responsibilities be if I participate?

Questions about Possible Risks/Benefits

  • What are my possible short-term benefits?
  • What are my possible long-term benefits?
  • What are my short-term risks, such as side effects?
  • What are my possible long-term risks?
  • What other options do people with my disease have?
  • How do the possible risks and benefits of this trial compare with those options?

Questions about Participation and Care

  • What kinds of therapies, procedures and /or tests will I have during the trial?
  • Will they hurt, and if so, for how long?
  • How do the tests in the study compare with those I would have outside of the trial?
  • Will I be able to take my regular medications while in the clinical trial?
  • Where will I have my medical care?
  • Who will be in charge of my care?

Questions about Personal Health Issues

  • How could being in this study affect my daily life?
  • Can I talk to other people in the study?

Questions about Financial Issues

  • Will I have to pay for any part of the trial such as tests or the study drug?
  • If so, what will the charges likely be?
  • What is my health insurance likely to cover?
  • Who can help answer any questions from my insurance company or health plan?
  • Will there be any travel or child care costs that I need to consider while I am in the trial?

At Emory Healthcare, our physicians and researchers want to answer all your questions about clinical trials and research. View some of our frequently asked questions, or hear from our patients who have gone through clinical trials.

Related Resources

Understanding Clinical Trials – Part 3: What are the Phases of Clinical Trials?

Phases of Clinical TrialsThe goal of clinical trials is to determine if new treatments, drugs and care-delivery processes are safe and effective. Discovery and data collected from clinical research studies impacts patient care, here and now, while also informing future generations with the hope of achieving better outcomes. But clinical studies do not happen overnight, and in fact, some take years to yield enough information to answer specific questions they are designed to answer.

Clinical trials take place in “phases,” and each phase helps researchers answer specific questions. Learn more about the different phases of clinical trials below:

Phase I:

These trials are used to test brand new drugs, devices or procedures to find out how safe they are, including safest dose, and identify possible side effects. They usually involve 20 to 80 people.

Phase II:

These trials are used to further evaluate the effectiveness of a drug, device or procedure. The researchers keep track of any medical benefits, as well as side effects. They usually involve 100 to 300 people. At the end of Phase II trials, the U.S. Food and Drug Administration (FDA) and trial sponsors determine how Phase III trials will be conducted.

Phase III:

These trials compare a new treatment or procedure to current treatments to figure out which works better. Safety and level of effectiveness continued to be monitored, as well as side effects. They usually involve 1,000 to 8,000 people.

Phase IV:

Once a drug or procedure is approved by the FDA and made available to the public, researchers continue to study its safety to figure out the best use of the new treatment. Information is gathered on the drug’s long-term effectiveness in various populations, as well as adverse side effects associated with long-term use. In the video below, Dr. Donald Harvey walks through the different phases of cancer-specific clinical trials.

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Understanding Clinical Trials – Part 2: What are the Benefits of Clinical Trials?

With any clinical trial, there are both benefits and risks associated; however, clinical trials are not just for sick people, unlike common perception. Both healthy people and people with certain diseases or conditions participate in clinical trials. While some participate to receive care or treatment only available through a clinical trial, others participate to help researchers find better treatments.

For researchers, physicians and health care professionals, clinical trials are extremely important because they allow us to make real-time differences in medicine. Treatment regimens, drugs and care-delivery protocols all exist today because of clinical studies conducted in the past. Clinical trials and research provide not only hope for our patients, but a possibility for better outcomes and medical advancements in the future.

As a leading academic medical center, Emory Healthcare is proud to offer more than 1,000 clinical trials to our patients. Some direct benefits patients receive by participating in clinical trials include:

  • Access to new treatments that are not yet available to the general public
  • Access to more effective treatments than the standard care therapies
  • Close oversight from medical experts at a leading health care facility in the Southeast
  • Helping others by contributing to medical research

The decision to participate in a clinical trial is completely voluntary; therefore, to help you and your loved ones decide whether or not to participate, it is important to understand any potential risks. The known risks and benefits are different depending on the clinical trial, so make sure you talk to members of the research team before making a decision.

In the video below, Emory researchers and doctors discuss the benefits of clinical trials.

Related Resources

Learn More About Clinical Trials at Emory Healthcare
Find a Clinical Trial at Emory

Is Insomnia Linked to High Blood Pressure?

insomnia clinical trialWith more than 1,000 clinical trials underway at Emory, today’s research is giving patients and families a better tomorrow. Read about one of our active nursing clinical trials below:

Hypertension, or high blood pressure, is a common but serious condition. According to the Centers for Disease Control and Prevention, about 1 in every 3 adults in the United States (about 70 million people) has high blood pressure.

Having high blood pressure means the pressure of blood in the blood vessels is higher than it should be, which can be a risk factor for heart disease and stroke, two of the leading causes of death for Americans.

While hypertension can be controlled through prescribed medications, lifestyle changes are equally as important. A healthy diet and exercise are known ways to lower blood pressure, but a clinical trial currently underway at the Nell Hodgson Woodruff School of Nursing at Emory University is investigating whether adequate sleep also helps reduce high blood pressure.

Insomnia – or trouble getting to sleep, staying asleep or early morning awakenings – is a very common sleep disorder associated with decreased quality of life, reduced work productivity and increased health care costs. In recent years, insomnia has also been associated with hypertension and cardiovascular disease.

In this particular study, funded by the American Heart Association, participants participate in an online sleep improvement program once a week for six weeks. The goal of the trial is to determine if the program is effective in lowering blood pressure and improving sleep, mood and cognition in people with insomnia and high blood pressure.

Do you have high blood pressure? Do you have trouble sleeping? Eligible participants will receive compensation for their time and effort. For more information, click to view the informational flyer for this trial>>

Related Resources

Find an Emory trial
Clinical Trials – FAQs
Understanding Clinical Trials – Part 1: What are Clinical Trials?
Emory School of Nursing

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