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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

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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.