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

 

Mount Vernon Now Enrolling For COVID-19 Clinical Trials, Testing, Vaccine, and Treatment

Wake research provides investigational health services to COVID patients nationwide via the newest clinical research trials

Seven Sites Now Enrolling for COVID-19 Vaccine Trials, Testing, Inpatient and Outpatient COVID Treatment Studies

(Raleigh, NC) June 10, 2020– Wake Research, a national leader in clinical research and one of the largest Phase I-IV clinical trial service companies in North America, announces the commencement of several new clinical research trials to help patient communities battle the COVID-19 pandemic, including trials for COVID vaccines, COVID diagnostic testing, and inpatient and outpatient care for patients with COVID-19. Seven Wake Research sites in six states will be participating in the trials, including North Carolina, Georgia, Tennessee, California, Nevada, and Texas.

“We are excited to be able to participate in these trials and to offer ground-breaking investigational treatment to COVID patients (inpatient and outpatient) across the country,” states Ella Grach, MD, President and Chief Executive Officer of Wake Research. “Our entire team is working diligently to assure patient safety in compliance with CDC and local public health authorities’ guidelines while maintaining the highest quality and integrity metrics, and streamlining processes to ensure the most efficient and effective patient care and recruitment rates. Our best defense against the global pandemic is efficient and well-run clinical trials providing high integrity data toward the discovery of new treatments,”  she adds.

COVID Clinical Trial Locations and Patient Information

Several of the Wake Research COVID-19 clinical studies are being conducted in partnership with local hospitals, particularly for inpatient treatment of COVID patients:

Fayetteville, NC – A COVID-19 inpatient treatment trial initiated the first week of June, at the CICR site in Fayetteville, in partnership with Cape Fear Valley Hospital nearby. 1841 Quiet Cove, Suite 2, Fayetteville, NC 28304. For more information, call (910) 302-8151 or visit www.ci-cr.com. Inpatient and outpatient treatments.

Las Vegas, NV – Through Wake Research’s site in the Las Vegas area, CRCN, there will be both out-patient and inpatient COVID trials conducted in partnership with a local hospital: 1012 E Sahara Ave, Las Vegas, NV 89104. For more information, call (702) 893-8968 or visit www.crcnevada.com. Inpatient and outpatient treatments, vaccine, and COVID test.

Other locations for Wake Research COVID-19 clinical trials include:

  • Raleigh, NC – Outpatient treatment, vaccine, and COVID-19 test. Wake Research site – 3100 Duraleigh Rd., Suite 304, Raleigh, NC 27612. For more information, call (919) 781-2514 or visit www.wakeclinical.com.
  • Atlanta, GA – Outpatient treatment. Mount Vernon location of Wake Research. 755 Mount Vernon Highway NE, Suite 200, Atlanta, GA 30328. For more information, call (404) 419-1857 or visit mvclinical.com.
  • Chattanooga, TN – Outpatient treatment. 6035 Shallowford Rd., Suite 109, Chattanooga, TN 37421. For more information, call (423) 698-4584 or visit

www.clinsearch-us.com.

  • San Diego, CA – COVID-19 test and outpatient treatment. 9040 Friars Rd., Suite 540, San Diego, CA 92108. For more information, call (619) 521-2841 or visit www.mccresearch.com.
  • Dallas, TX – COVID-19 test and outpatient treatment. Global Medical Research. 2701 S. Hampton Rd. Suite 250, Dallas TX, 75224. For more information, call (972) 996-5645 or visit globalmedicalresearch.us.

Potential patients interested in learning more and potentially enrolling in a study may visit www.wakeclinical.com. If selected to participate in a study, patients are compensated for their time and travel.

“In addition to receiving the highest quality of care from some of the best physicians in the clinical research field, participants in these studies are contributing to the future of medicine, providing key insights and data needed to develop a treatment or vaccine for COVID-19,” Dr. Grach states. “The first wave of Covid-19 Infection in many places is getting under control. That is a great accomplishment, and it’s really crucial that we use this window of opportunity to conduct clinical trials to develop much needed treatments,” she concludes.

Wake Research is owned by M3, Inc., a global healthcare services company with businesses in more than a dozen countries, including medical research, media, and workforce/staffing services. For more information, visit https://www.wakeresearch.com.

About Wake Research, Inc.:

M3-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. M3-Wake Research’s 16 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.

M3-Wake Research is known for effectively combining strategic volunteer recruitment, rapid trial start-up, and subject enrollment/retention with high-quality clinical trial conduct, using standardized operating procedures and centralized marketing and advertising to ensure rapid subject enrollment. M3-Wake Research sites have conducted more than 7,000 research studies for hundreds of pharmaceutical and biotech sponsors and CROs. Wake Research’s mission is to bring novel medications, biologics, and devices through clinical research to as many people as possible while providing unparalleled service and exceptional value to clinical trial partners and stakeholders.

About M3 Inc.:

M3 Inc. operates in the US, Asia, and Europe with over 4 million physician members globally via its physician websites such as mdlinx.com, m3.com, research.m3.com, doctors.net.uk, medigate.net, and medlive.cn. M3 Inc. is a publicly-traded company on the Tokyo Stock Exchange (TYO:2413) with subsidiaries in major markets including the USA, UK, Japan, S. Korea, and China. M3 Inc. provides services to healthcare and the life science industry. In addition to market research, these services include medical education, ethical drug promotion, clinical development, job recruitment, and clinic appointment services. M3 has offices in Tokyo, Washington D.C., Fort Washington, PA, Oxford, London, Beijing, and Seoul.

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 Mount Vernon Clinical Research, as part of 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

Our Staff Discusses COVID-19 Crisis on WPTF Podcast

Aubrey Farray is the Phase I clinical manager at Wake Research in Raleigh, N.C., the headquarters of the site network Mount Vernon Clinical Research 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 during COVID-19.

Farray also tells Aging Well how Wake Research and all of its sites are 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: