Tag: covid-19

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

 

Carolina Institute for Clinical Research Begins Recruiting Healthy Adults for COVID-19 Vaccine Clinical Trial

Fayetteville, NC; August 10, 2020 – Carolina Institute for Clinical Research announced today it has begun recruiting healthy adults for a Phase 3 clinical research study to evaluate the safety and effectiveness of mRNA-1273, a vaccine candidate against COVID-19. Sponsored by Moderna, the COVE Study is recruiting healthy volunteers ages 18 or older in high-risk populations, including the elderly, racial and ethnic minorities at higher risk for COVID-19, and essential workers in close contact with potentially infected persons.

The Phase 3 study will evaluate if mRNA-1273 boosts the immune system to produce enough antibodies against SARS-CoV-2, the virus that causes COVID-19, so it does not cause illness in case of infection.

“We are excited and hopeful as we begin participating in the COVE Study, understanding this is one of the most important and impactful clinical research studies in our lifetime,” said Dr. Grach, CEO, Wake Research. “We encourage individuals across the Fayetteville area to consider participating in this trial, which could bring the world one step closer to ending this global health crisis.”

To be eligible for the study, healthy volunteers must be 18 years of age and older with no known history of SARS-CoV-2 infection or previous participation in an investigational coronavirus vaccine. Within this population, Carolina Institute for Clinical Research is prioritizing candidates whose locations or circumstances put them at higher risk of exposure to the virus, including:

  • Elderly, ages 65 and older
  • Essential workers in close contact with potentially infected persons, including, but not limited to, healthcare and hospital workers, first responders, transit employees, institutional residents or workers, factory employees, and teachers and students
  • Racial and ethnic minorities at high risk for COVID-19

If a person is eligible and decides to participate, the research staff at Carolina Institute for Clinical Research will randomize patients to receive either the mRNA-1273 vaccine or a matching placebo. The total length of participation is 25 months and includes approximately seven visits to the clinic and 24 phone calls.

Carolina Institute for Clinical Research is one of 89 research sites across the country participating in the COVE Study. If someone is interested in participating in clinical research in their area, call

(910) 302-8151 or visit www.ci-cr.com/ to learn more.

About Carolina Institute for Clinical Research

Carolina Institute for Clinical Research is a multi-disciplinary clinical research site that brings many years of experience and leadership in the research community to the Fayetteville area. Our research site effectively combines strategic accelerated volunteer recruitment and retention with high-quality clinical trial conduct practices. Our approach is uncompromising – each study conducted at our site is carefully planned and executed according to protocol and regulations with superior quality.

Media Contact

Andrea Clement
[email protected]

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 CICR 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