After generations of status quo clinical trials in America, there is now a team of allied professionals that is leveling the clinical trial playing field. Its high tech, decentralized patient-centric approach aims to help millions of people break though roadblocks to the best possible health care.
Pharmaceutical trials expert and CEO/founder of The PharmaKon LLC, Gail Trauco, R.N., BSN-OCN has spent four decades helping patients navigate the red tape of the U.S healthcare system. During a Merck Drexel Advanced Leadership Program for Diverse Suppliers (ALP) in early 2021, Trauco met and joined forces with Dr. Kelly Nguyen, a multi-award-winning leader in Connected Health Technology, and Mr. Chris Monica, President of Magno International and a comprehensive supply chain expert who has been providing solutions to Fortune 1000 companies for over 30 years. By combining their expertise via the Pharmakon, they have every piece of the puzzle needed to deliver open and inclusive clinical trials that many healthcare organizations have only talked about.
“Virtual nursing and remote nursing providers have rapidly evolved due the pandemic. Nurses were forced to work from home to minimize office staff, and patients were encouraged to use telemedicine,” says Trauco, a 43+ year Oncology nurse and long-time patient advocate. “One major shift is that patients often no longer need to leave their home or miss a simple study, visits such as lab draws or IV infusions can be done remotely. Clinical study medications are prepared and delivered via courier to a patient’s home. A remote nurse oversees medication administration. Patient data is collected in real time and entered in HIPPA secure Electronic Data Capture systems.”
According to Trauco, decentralized clinical trials represent the future by bringing investigational studies to the patient. Three nursing specialties are being used by The PharmaKon to staff its clinical trials: virtual nurses, remote mobile nurses, and patient concierges. Virtual nurses work remotely through telemedicine portals and EDC systems with clinical trial data. Remote mobile nurses visit patient homes. Patient concierge nurses oversee daily patient calls and perform compliance checks via remote monitoring and/or phone calls. Sponsors are encouraged to design new study protocols for procedures such as labs, vector samples (stool, semen, saliva, urine), vital sign monitoring, EKGs, and health assessments to be completed remotely.
For nearly 30 years, The PharmaKon’s dedicated government and public health services group has successfully delivered clinical research services to various agencies, contractors and nonprofits in both prime contractor and subcontractor capacities within full compliance of all federal contracting requirements. Its services have supported the organizations in conducting therapeutic, vaccine and medical device studies throughout North America across all trial phases and therapeutic areas. The PharmaKon has a unique understanding and connection to rural healthcare and underserved communities by way of Trauco’s personal experiences growing up on a family farm in her native North Carolina.
“Over the last two decades few changes have been made to ensure inclusion and diversity in clinical trials,” adds Curtis Wilson, VP Clinical Operations at The PharmaKon. “Women, especially women of color, were previously less likely to enroll in clinical trials. Deterring factors have included lack of awareness of opportunities, transportation and childcare issues. Our game changing approach is bringing clinical trials to rural and marginalized communities. Mobile nursing and in-home vital sign monitoring via FDA approved applications that we have in place now open doors for women and minorities to be enrolled in clinical trials.”
In the past, exclusion of women who are of child-bearing potential impacted the efficacy of drug safety data, especially for drugs specifically being studied to treat women. Phase I clinical trials are first in human drug studies which are most often dose ranging and monitor safety/efficacy. The Maximum Tolerated Dose (MTD) from Phase I data is used for Phase II clinical trials. Phase II clinical trials are conducted to see if the drug works. Phase III trials compare the safety and efficacy of the clinical trial drug to the FDA approved standard. From 1977 to 2003 most drugs removed from the market or included in top class action lawsuits were resultant of adverse side effects experienced by women.
The PharmaKon’s team of mobile nurses are pioneering a new era in healthcare. Clinical trials are now available to patients who otherwise would not be able to participate in studies. Rural and marginalized communities, LGBTQ, people of color and low-income patients now have an equal opportunity to take part in innovative clinical trials. For more information about The PharmaKon and its industry leading, decentralized clinical trials go to: www.ThePharmaKonLLC.com.
About Gail Trauco, R.N. BSN-OCN
Based just outside Atlanta, CEO/founder of The PharmaKon LLC Gail Trauco frequently travels around the United States to help patients, medical practitioners, and pharmaceutical companies align on best case solutions. She has gained a reputation as a fierce advocate for patient’s rights and for resolving some of the most difficult medical cases in the currently crippled American healthcare system. Guided by state & federal guidelines, her decades of medical care experience and innate intuitive skills, Trauco consistently connects the right care and medical coverage for people in dire need of treatment from a broad range of illnesses.
About Dr. Kelly Nguyen, Pharm.D.
Dr. Kelly Nguyen is a multi-award-winning female entrepreneur and executive with a proven track record. She was named Cartier Women’s Initiative (CWI) 2020 North America Fellow for her advocacy to drive change for social good. Prior to DrKumo®, Dr. Nguyen was the Co-Founder/CEO of Mission Road Pharmacy, a specialty pharmacy with an annualized revenue of $160M+ and growing at more than 200% annually prior to getting acquired in 2012. Dr. Nguyen holds 2 granted and 4 pending patents in the field of Connected Health, Blockchain, and Cryptographic Identity Authentication technology, and a Doctoral Degree in Pharmaceuticals from the University of California, San Francisco.
About Chris Monica
Chis Monica has over 30 years of experience providing comprehensive supply chain solutions to Fortune 1000 companies. He is renowned for his strategic, value-based approach and ability to build durable relationships with clients. He provides strategic direction, cultivates and manages relationships with new and existing clients, and drives culture at Magno International. He is the author of the company’s mission statement and its tagline of “speed and accuracy” in all we do. Chris is a graduate of the University of San Diego and resides in Southern California with his wife Laura.
John Stellar / Everyone’s PR (818) 853-7100