Tag: clinical trials

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.

Diversity

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!

FAQ

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: http://curtismediagroup.hipcast.com/rss/eyeonehealth.xml

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?
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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:

https://www.cdc.gov/vaccines/vac-gen/10-shouldknow.htm

https://www.who.int/immunization/research/en/

https://www.who.int/news-room/campaigns/world-immunization-week/world-immunization-week-2020/key-messages