Author: Matt Crist

Vaccines Aren’t Trendy, They’re Essential

Vaccines are not trendy, They are essential banner

Vaccines are the most important thing we can do for ourselves and our children to protect against various illnesses. They do this by helping prepare our immune systems to fight off infections and prevent disease. Vaccines prevent up to 3 million deaths worldwide. Thus, they aren’t trendy when we think about vaccines; they’re essential.

How Vaccines Work

Image of COVID vaccine bottles


The COVID-19 pandemic brought more information and attention to vaccines and how we produce them. When we get sick, our immune system sends out special white blood cells that fight against the illness and helps heal the body. Once the body has beaten the virus or disease, other cells in the immune system recognize and remember how this was done in case the body reencounters the same disease.

Vaccines contain weakened or inactive parts of a particular organism. This triggers an immune response within the body to respond the same way it would on its first reaction to the actual pathogen. Newer vaccines contain the blueprint for producing illness-fighting antigens rather than the antigen itself, regardless of whether the vaccine is made up of the antigen itself or the blueprint so that the body will produce the illness-fighting antigens.

Vaccine Types

Scientists take many approaches to develop vaccines. These approaches are based on information about the diseases the vaccine will prevent. Today there are five main types of vaccines we receive in the U.S.:

  • Live attenuated vaccines contain a version of the living virus or bacteria that have been weakened so that it does not cause severe disease in people with healthy immune systems.
  • Non-live vaccines are made by inactivating, or killing, the germ during the process of making the vaccine.
  • Toxoid vaccines prevent diseases caused by bacteria that produce toxins (poisons) in the body. These vaccines are made by killing or weakening the toxins so they cannot cause illness.
  • Subunit vaccines include only parts of the virus or bacteria, or subunits, instead of the entire germ.
  • Conjugate vaccines fight a type of bacteria that has antigens. These bacteria have antigens with an outer coating of sugar-like substances called polysaccharides. Conjugate vaccines are effective for these types of bacteria because they connect (or conjugate) the polysaccharides to antigens that the immune system responds to very well.

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Vaccines are the safest way to protect yourself and your family against certain diseases and prevent serious illnesses. Natural infections can cause severe complications and be deadly, even for diseases that many consider mild, like chickenpox. It is impossible to predict who will get a severe illness that may lead to hospitalization or even death.

Interested in learning more about enrolling in vaccine studies?
All enrolling Studies



How Stress Affects Your Health

Banner with lady sticky notes on her face

Self-preservation is hard-coded into our bodies and reveals itself in various ways. Your stress response is a series of changes triggered by the brain that prepare your body to face a real or perceived threat. While the body was made to handle these short-term boosts, chronic or long-term stress can have lasting effects on your health.

Fight or Flight

Stress affects all body systems, including the musculoskeletal, respiratory, cardiovascular, endocrine, gastrointestinal, nervous, and reproductive systems. We need to first look into how the brain switches the body into fight-or-flight mode. This mode powers up the body to quickly eliminate the threat or successfully escape it. It starts with the hypothalamus prompting the adrenal glands to release a surge of adrenaline, cortisol, and other hormones. Below is a summary of their functions:

  • Adrenaline boosts energy supplies and increases your heart rate and blood pressure.
  • Cortisol curbs non-essential functions, increases sugar levels in the blood, and enhances the brain’s use of glucose. Cortisol also alters the immune system response by increasing the availability of substances necessary to repair tissues.

Someone Left the Stress Response On

Though our ancestors faced many more physical harm or death threats, perceived threats are a more common source today. A threat is any situation where the demands exceed our ability or desire to cope. Because each of us bases a threat on our perception, what stresses one person, may not another. Financial issues, family troubles, and heavy workloads are some stressors many individuals face today. These particular examples are not only prevalent; if they do resolve, it can take a while.

Man with hand on his head from stress

When a stressor is always present, the stress response stays on instead of shutting off once the threat is gone. A chronic increase in the heart rate, blood pressure, and glucose levels can lead to numerous complications. Damage to the heart, veins, and arteries in the body are examples of complications from chronic stress and why it can be so widespread and devastating. For instance, every cell in the body relies on a steady supply of oxygen-rich blood and other nutrients to function and live.

When the transport system (veins and arteries) and driving force (heart) that transport the supply are damaged, they cannot nourish the cells in the body effectively. The head-to-toe mental and physical effects include:

  • Anxiety
  • Depression
  • Digestive problems
  • Headaches
  • Muscle tension and pain
  • Heart disease
  • Sleep problems
  • Increased weight
  • Memory and focus impairment

The American Psychological Association’s (APA) website explains more about the effects of stress on the body’s systems. Learn more about the eye-opening details here.

Advancing Care Options for Chronic Conditions, Stress-Related, or Not!

April is Stress Awareness Month. We encourage you to take this month-long heightened awareness opportunity to learn how to manage and lower your stress levels. The American Heart Association has a lot of great FREE resources on stress management, with many others just an internet search away!

Stress Management resources

Carolina’s GI Research is one of 24 clinics integrated with Wake Research spanning 7 different states. We conduct clinical trials to advance treatments and resources for chronic medical conditions and other therapeutic areas. Partnerships with healthy volunteers and those with medical conditions help make these advancements possible by participating in research studies.

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Whether you’re living with a chronic condition resulting from stress or not, participating in research studies may help. To find a list of available studies in your area, you can search by your zip code on our website or contact us at (984) 232-2360 today!





HPV Diagnosis, Now What?

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Although 4 out of 5 people will contract the human papillomavirus (HPV) in their lives, receiving a positive test for it can still be surprising. Most cases go away on their own, but some types can cause genital warts and cancers. The good news is that knowing you have an HPV diagnosis means you can do something about it. Here’s what to expect after.

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Colposcopy: A Closer Look

Having HPV doesn’t mean you have definitely have cancer; it means you are at higher risk than someone without HPV. After diagnosis, your doctor will need to get a closer look at your cervix and areas with abnormal cells. A colposcopy is a procedure that uses a magnifying device with a light to examine these areas that the naked eye cannot see.

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A biopsy may be taken to get an even closer look under a microscope if there are areas of concern. Depending on what they find and the severity of the abnormalities, your doctor may:

  • Recommend waiting to see if the cells heal themselves. In the meantime, you will have another pap smear or other test to watch the cells.
  • Remove all abnormal cells during the biopsy, and further treatment isn’t necessary.
  • Give you a referral or recommend further treatment.

In addition, you should talk to your partner about getting tested and practicing safer sex to avoid spreading HPV if they don’t have it.

Removing Abnormal and Pre-Cancerous Cells

If the abnormal cells found are considered pre-cancerous or are at high risk for being pre-cancerous, removing them will help prevent cervical cancer. Here are four very effective procedures:

  • Cryotherapy – Freezes abnormal cells off.
  • Loop electrosurgical excision procedure (LEEP) – A thin wire loop that carries an electrical current removes the abnormal cells.
  • Laser – A particular type of laser is used to remove abnormal cells.
  • Cone biopsy – A cone-shaped wedge is cut out of your cervix to remove the abnormal cells.

Cancer and Other Treatments

Cervical cancer is very treatable, especially when it’s caught early. If your cells show signs of cancer, your doctor will refer you to a gynecologic oncologist. They specialize in treating cervical cancers and will determine the extent of the disease. From there, they will talk to you about cervical cancer treatment options such as chemotherapy, surgical, and radiation therapy.

Contracting the virus through skin-to-skin sexual contact can also result in genital warts or lesions on your tongue, tonsils, soft palate, larynx, or nose. Depending on the type, prescription treatments are available to help provide relief.

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Having HPV means you have the power to help yourself. But did you know being HPV positive can also help improve how we diagnose, treat, and prevent it too? As a clinical research volunteer, you can play a unique role in a better future with HPV. Explore our enrolling studies for individuals with an abnormal pap smear result and those living with HPV today! Call Carolina’s GI Research at (984) 232-2360 or visit our enrolling studies webpage.





Advancing Medicine Takes Heart

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Improving Options for Top Women’s Healthcare Issues

Women are unique and diverse both as individuals and as a whole. These are some of the driving forces behind the demand for better care solutions for conditions prevalent in women. The clinical trials we conduct here evaluate potential new options for some of the top health issues women face. Here are three areas featured in our enrolling studies and some information about them:

        • HPV– Human papillomavirus (HPV) is the most common sexually transmitted infection. Most sexually active people are infected with HPV at some point in their life. There are over 200 different types of HPV. About 40 of them can infect your genital area — your vulva, vagina, cervix, rectum, anus, penis, scrotum, throat, and mouth. Most genital HPV infections go away on their own, but some high-risk kinds can lead to genital warts or certain types of cancer.
            • There’s no cure for HPV, but individuals living with HPV can help advance its options. To learn more about our enrolling HPV-positive studies, click here.

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    • Abnormal Pap/Colposcopy– Annual pap smears are a proactive measure that screens for cervical cancer and other abnormal changes to the cervix. A colposcopy procedure can provide more information when a pap smear comes back abnormal. The procedure uses a magnifying device called a colposcope. It shines a light and enlarges the view of the cervix to closely examine abnormal cells which aren’t visible by the eyes alone.  
      • Birth Control– The options for birth control have grown a lot in recent years. With various methods (implant, IUD, shots, pills, etc.) available, finding a suitable one that fits your lifestyle is easier than ever. More potential new options are being evaluated in clinical trials. By participating in birth control research studies, you play a direct role in advancing contraceptive options. It is also an excellent opportunity to try different birth control methods.
        • To get more information about our birth control studies, click here for enrolling IUD studies and here for birth control pill studies.

      To learn more about participating in research or our enrolling studies, visit our Enrolling Clinical Research Studies webpage or call us at (984) 232-2360 today!



Why You Should Volunteer in a Trial

Want to help out others this new year?

Giving back in a meaningful way as an individual is a great way to help others and strengthen your community. Volunteering also comes with life-changing personal benefits not everyone knows about. Do you want to help others in the New Year? Keep reading to learn why you should consider volunteering in a clinical trial!

Volunteers and Clinical Trials

When most people look for a volunteer opportunity, they often don’t think of doing so through a clinical trial. Clinical trials rely on partnerships with healthy and patient volunteers to evaluate the safety and effectiveness of potential new treatments. When a new treatment is discovered, it must go through the four phases of a clinical trial before it can be made available to the public.

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In the early phases of clinical trials, healthy volunteers help determine the delivery method of the potential new therapy, optimal dosage amounts, and more. In the middle and later phases, patients with the study’s condition will help evaluate how safe and effective the potential new therapy is as it compares to other therapies currently on the market.

Women in Clinical Trials

Despite the many advances and breakthroughs resulting from women’s health research, there is still much work yet to do. One of the most significant disparities in treating women’s health issues is information gathered from primarily male-dominated data. This is mainly because when some of the most common treatments in use today were being evaluated in clinical trials, women were banned from participating.

Diverse women

Even after lifting the ban, numbers still trickled in, and women remain an underrepresented population today. So why is this important? It’s important because women’s bodies work differently than men’s. Not having enough women present in a trial can create treatment outcomes that can lead to overdosing, serious side effects, and more.

Leader in Health Research

Giving back has many potential benefits. Research evidence proves it helps with mental health issues by improving symptoms of depression and anxiety. Other benefits include:

  • Learning more about your condition so you can take better care of your health.
  • Advancing medicine helps improve the lives of future generations.
  • Potentially gaining access to new therapies not currently on the market that may have fewer side effects and be more effective than current options.
  • Being eligible for incentives as a part of study participation such as travel and time reimbursements.
Clinical research is changing the world

Carolina’s GI Research is a leader in health research. Through the clinical trials we conduct and the partnerships with people like you, our mission is to advance options for all health conditions. We have several opportunities for you to get involved in. Call us at (984) 232-2360 or stop by our website TODAY!


Clinical Trials: Diverse Groups Of Participants Are Needed Now More Than Ever

Why Clinical Trials are Safe

Prior to new medicines being mass-produced and available to doctors to prescribe, clinical trials must be conducted in order to evaluate the safety and effectiveness of that medicine. Data from these clinical trials are required as a condition of approval by regulatory authorities such as the U.S Food and Drug Administration (FDA).

Clinical Trials in the United States are regulated by the FDA. Before a new treatment is tested on any humans, the potential drug first goes through a strict review in laboratories. This is followed by testing on animals, such as rats and mice. After each phase, of research, the clinical trial team must submit an “Investigation New Drug” application to the FDA. This document is reviewed by the FDA along with an independent ethics committee.

Clinical Trials are extremely transparent with volunteers. The informed consent process is designed to protect participants. Prior to officially joining a clinical trial, a potential volunteer will be told what to expect and all things that may happen during the trial. After being told this information, the volunteer can decide whether he/she would like to join the trial and move to the next steps.


With COVID-19 being a major threat to the population’s well-being, clinical trial participation is needed now more than ever before. Along with overall participation, it is also important to remember that for a clinical trial to produce the best medicine possible, a strong sense of diversity is needed in testing.

Differences between people often lead to different responses to the same medicine. These differences can vary from the weight, ethnic origin, even geographic location. Each of these variations in a person’s genetic makeup could play a crucial role in how a treatment may work and how safe it may be. For example, African Americans sometimes need a different dosage — or a different drug altogether — for certain asthma, blood pressure, and heart conditions than white, Asian, or Hispanic patients with the same diagnoses. Instances like this are why diversity in clinical trials becomes so pertinent in success.

According to U.S. Census data, Black or African Americans represent 13.4% of the U.S. population, however, FDA reports that those populations make up only 5% of clinical trial participants. The disparity is even greater for those of Hispanic or Latino origin. They represent 18.1% of the U.S. population but only 1% of clinical trial participants. This underrepresentation leads to unknown variables in different medicines and could cause certain medications to not be equally safe and effective for all populations.

Next Steps

For additional questions, visit our FAQ page. It’s time for our community to take a stand and work together to find a vaccine for COVID-19!


What To Expect


Our Staff Discusses COVID-19 Crisis on WPTF Podcast

Aubrey Farray is the Phase I clinical manager for Wake Research, the headquarters of the site network Carolina GI belongs to. He recently spoke with hosts Jason Kong (WPTF) and Nicole Clagett (Transitions GuidingLights) of WPTF’s Aging Well podcast on clinical trials in the COVID-19 crisis.  In the interview, he details the process of clinical trials, explaining what participating in a clinical trial entails for those who have questions, and discusses how the elderly population can still participate in ongoing clinical trials, and do so safely.

Farray also tells Aging Well how Wake Research is keeping current clinical trials safe for all participants during the COVID-19 crisis and emphasizes the important role clinical trials have right now in researching and testing drugs to treat COVID-19.

Listen to the full interview here:

Aging Matters Podcast:

Vaccine Awareness: What You Need To Know

Vaccines: Importance and Frequently Asked Questions

Right now, there is a large focus on the urgent need to develop a vaccine for COVID-19, the disease caused by the novel coronavirus that currently has no approved treatment or immunization. This has brought an awareness to vaccine research and development, and just how important it is more than ever.

There is a lot of misinformation that circulates regarding vaccines and what immunization does, so here are a few of the frequently asked questions about vaccines, answered.

Why should we vaccinate?

Vaccines and childhood immunization are vital practices to protecting yourself, your children, and the entire population from contracting dangerous diseases and from preventing outbreaks and pandemics.

As we are experiencing now with COVID-19, pandemics are scary, life-changing and affect much more than just our health and daily lives. Vaccines protect against diseases that have the possibility to become pandemics, and by continuously vaccinating, it is even possible for diseases to become completely eliminated – for example, smallpox.

How do vaccines work?

Vaccines create immunity in the body. When a virus infects the body, the immune system responds to this antigen with antibodies designed to fight it. The first time the body is infected with a specific antigen, the immune system must create those antibodies, which is why you get sick. But if that antigen infects you again, the immune system can recognize it, already has those antibodies, and can fight it off before you get sick.

Vaccines help this process by containing parts of the antigens that are weak enough to not infect you but are still strong enough to elicit an immune response – giving the body protection if ever exposed to this disease again in the future.

Do vaccines cause side effects? Are there risks?

Vaccines can cause minor side effects. These are usually very mild, like a sore arm at the site of the shot or a low-grade fever, and only last a few days. Like any medication or medical treatment, vaccines are clinically tested for safety and continuously monitored to ensure no adverse side effects are experienced. Also like any medication, some individuals may have a more serious reaction and need medical attention. But this is very rare. The protective benefits vaccines provide greatly outweigh the risks of side effects. As always though, discuss the risks and benefits vaccines provide with your doctor.

What diseases do vaccines prevent?

Vaccines protect against many dangerous viruses and diseases that without protection can have serious health consequences like disability or death. These include:

Chickenpox (Varicella), Diphtheria, Flu (Influenza)

Hepatitis A, Hepatitis B, Hib (Haemophilus influenzae type b)

HPV (Human Papillomavirus, Measles, Meningococcal (Meningitis)

Mumps, Pneumococcal (Pneumonia), Polio (Poliomyelitis)

Rotavirus, Rubella (German Measles), Shingles (Herpes Zoster)

Tetanus (Lockjaw), Whooping Cough (Pertussis)

What is Vaccine Research and Development?

Another important part of immunization is ongoing vaccine research and development. For example, COVID-19 was just introduced to humans this year– meaning no one had built-up immunity for it, nor was there a vaccine to protect against it. Currently, researchers, scientists, doctors, and pharmaceutical companies are working hard to develop a vaccine for COVID-19 so that people all over the world can be protected from this deadly disease.

What would a vaccine mean for COVID-19 specifically?

To date, COVID-19 has affected over one million people in the United States alone. As that number continues to rise across the nation and globe, researchers are hoping to develop a vaccine that would help treat the disease and limit its spread – a vital practice with a disease as contagious as COVID-19.

Vaccines, in general, are effective in limiting the spread of disease by providing immunity. When individuals are immune to a disease, they are unable to be infected by it, which means they will not be able to pass it on to others either.

Interested in taking a 5 question survey on COVID-19 clinical trials and vaccines?
Click Here For Survey

At Wake Research, as a clinical site network, we play a vital role in the vaccine research and development process. At our sites, we conduct vaccine studies where vaccines can be clinically tested for safety and effectiveness for diseases like COVID-19 and more. All current vaccines once had to be put through clinical trials like the ones being conducted now.

Immunizations work and can help to save many lives. For more vaccine information, visit the following sites:

Wake Research Announces Partnership with Carolina’s GI Research

Wake Research partners with Carolina’s GI Research

Partnership to Increase Clinical Research Opportunities for Patients, Sponsors
in Greater-Triangle Area of North Carolina

(Raleigh, NC) – Raleigh-based Wake Research (Wake Research Associates, L.L.C.) announces a partnership with Carolina’s GI Research, with locations in Raleigh, Clayton, Cary and Wake Forest, North Carolina. The partnership brings the total number of Wake-owned and affiliated sites to 18, located in six states where Wake Research operates in the South, Mid-South and Southeastern United States.

“We at Carolina’s GI Research are very excited to partner with Wake Research,” said Dr. Subhash Gumber, Medical Director of Carolina’s GI Research. “Not only will it help us stay up-to-date in gastroenterology, but we will also be able to offer latest treatments to our patients.”

Wake Research is a wholly-owned integrated network of clinical research sites consisting of 100+ physicians and clinical Investigators based on large private practices and large multi-specialty healthcare institutions.

Wake Research conducts clinical trials in all major therapeutic areas with particular experience in internal medicine, dermatology, women’s health, metabolic diseases, gastroenterology, men’s health, neurology, pulmonology, rheumatology, vaccines, and women’s health trials. Wake Research conducts clinical trials in all phases (1 thru 4) and owns and operates Carolina phase 1, a dedicated phase 1 and a pharmacokinetic unit located in Raleigh, NC.

In addition to a proprietary research database of 585,000 clinical trial participants, Wake Research has its own, in-house agency, research, marketing & advertising, which leverages outreach to more than 9.7 million individuals in our communities.

About Wake Research

Wake Research is an organization of integrated investigational sites, committed to excellence, working closely with and meeting the needs of the biopharmaceutical, biotechnology, medical device and pharmaceutical industries. Wake Research sites are fully equipped to meet the needs of sponsors and CROs in the conduct of Phase I-IV clinical trials in a large variety of indications.

Wake Research is known for effectively combining strategic volunteer recruitment and retention with high-quality clinical trial conduct, using standardized operating procedures and centralized marketing and advertising to ensure rapid subject enrollment. Wake Research has conducted over 5,900 research studies for hundreds of pharmaceutical sponsors and CROs since 1984. Wake Research’s mission is to bring novel medications, biologics and device thru clinical research to as many people as possible while providing unparalleled service and exceptional value to clinical trial partners and stakeholders.