Clinical Research as Clinical Care When Vaccines are in Short Supply.

Nov 7, 2023 | Blog

Dr. Rica Santiago
Coastal Carolina Research Center

mRNA advances opened a world of new drug development pathways with the success of COVID vaccines. The first-ever vaccine for RSV shortly followed, and today there are many exciting new opportunities in the biopharmaceutical pipeline to treat and prevent disease. However, the initial excitement has recently turned into widespread frustration, due to a massive vaccine shortage in the updated COVID-19 vaccines and RSV shots for children.

Dr. Rica Santiago, Principal Investigator at Coastal Carolina Research Center discusses the potential for an expanded role of clinical research to offset vaccine shortages and ensure broader vaccine access across a wide range of communities who may struggle to find them or face challenges in getting their insurance to pay for it. As the demand for vaccines outpaces supply, joining clinical trials emerges as a viable avenue for many to access these life-saving shots. The many benefits of vaccine clinical research participation include:

Expedited Access to Vaccines

Participating in vaccine clinical trials often means that study volunteers receive vaccines that are being evaluated as investigational products or FDA-approved vaccines that are considered standard of care. In either scenario, participants receive treatment they may otherwise be hard pressed to find. In situations where there’s a shortage, being part of a trial might provide individuals with earlier access to vaccines than the general public. It’s a win-win – participants have the potential for early access, and researchers gain valuable data.

Advancing Scientific Knowledge to Build on a Growing Body of Vaccine Evidence

All clinical trials generate valuable data for the scientific community to build upon – including the clinical trials that fail on treatment efficacy. As mRNA are a relatively new type of vaccines, knowledge building is mission critical to advance and accelerate the promise of mRNA technology across a wide range of therapeutic areas. More vaccines and more effective booster shots mean better distribution and improved access. By participating, individuals can accelerate this expansion, making vaccines available to more people, faster. It’s also worth noting one of the top motivations for participating in a research trial to help advance science for others.

Global Reach and Equitable Distribution

Clinical trials often occur simultaneously in multiple locations worldwide. Participating in these trials can bolster the data needed to approve vaccines in various regions, ensuring a more equitable global distribution. This is particularly crucial for areas experiencing acute shortages. There’s also the growing issue of health equity. Insurance reimbursement is not guaranteed and, in many cases, there’s a lag time before insurers will pay for associated costs. When vaccines aren’t readily accessible to the people who need them, it will ultimately drive up the cost of care. Clinical trial participation is a great way to receive medical care for free. The ongoing medical monitoring that is a standard part of every clinical trial is comprehensive and rigorous. Considering the average vaccine trial spans six months, participants may visit research sites every two to four weeks for early phase studies and every four to six weeks for Phase III trials, the level of personal medical attention and oversight is arguably superior to the medical attention received at a doctor’s office or clinic for a single vaccine.

 Alleviating Pressure on Mainstream Supplies

With a section of the population receiving vaccines through trial participation, the pressure on mainstream vaccine supplies is reduced. In practical terms, this means that vaccines from the primary supply chain can reach a broader audience, mitigating the effects of shortages.

As the world continues to navigate vaccine shortages, clinical trials offer a practical alternative and beacon of hope. They not only pave the way for scientific advancements but also provide a direct avenue for individuals to access vaccines. In the current climate, promoting clinical trial participation is more than just a call for scientific collaboration; it’s a call to action for community resilience and global health.

With nearly 25 years of experience in the research site space, Casey has a long and exemplary career history in pharmaceutical research site services including serving as past President of the Society for Clinical Research Sites (SCRS), a global organization representing nearly 10,000 clinical research sites in 47 countries within the pharmaceutical industry.

Casey began his career leading a large pharmaceutical research site network, Research Solutions. In 2007, he was recruited to join Clinical Research Advantage/Radiant as EVP of BD and successfully led a network of over 75 research sites conducting clinical trials for pharmaceuticals, vaccines, and medical devices. Under Casey’s leadership, several crucial partnerships were formed with major pharmaceutical companies which fueled the company’s rapid growth both geographically and therapeutically. He facilitated the acquisition of two competitors securing the company’s spot as what was at the time the largest clinical research site network in the US.

In 2015, Casey and the executive team at Radiant merged with Synexus, a division of PPD. With Casey’s guidance, Synexus continued to expand to 215 global clinical sites in 4 continents and over 15 countries. Casey also served as SVP of Pharmaceutical Relationships at StudyKik, a full-service patient recruitment and retention technology company. Most recently he was the Chief Commercial Officer for CenExel leading the sales and commercial team to become the largest independent wholly-owned site network of 18 sites specializing in both inpatient and outpatient services in the CNS space.

Casey is passionate about representing the site voice within the industry while ensuring every research patient’s journey is a positive one. As a thought leader in the industry, Casey is regularly invited to be a keynote speaker and panelist and is often quoted by the leading publications covering the clinical research landscape. In 2020, he was recognized in PharmaVoice as one of the 100 Most Inspiring People in the industry.

Chris Prader is the Chief Information Officer with more than three decades of diverse Information Technology and strategic management experience in leading IT. His career extends not only nationwide, but also globally, as he’s lived and worked internationally throughout Europe, Asia, and Australia.

As CIO of Alcanza, Chris oversees the management, integration and usability of data and information technology within the organization. Along with his team, Chris has helped to make operations more streamlined through technological innovation and transition.
Chris earned a Master of Business Administration degree from St. Joseph’s University in Philadelphia, PA, and a Bachelor of Science from Arizona State University. He is also a member of the Delta Tau Delta Fraternity.

When not working, you can find Chris vacationing with family and “in the sky” as a private pilot.

Rachel Truxall is VP Study Start Up and Performance. She oversees central call center operations, community engagement, and study delivery across Alcanza’s network of sites.

With more than 20 years of combined experience in health care, public health, and leadership roles, Rachel most recently served as Director, Delivery of North America for AES/Synexus, PPD’s global network of clinical research sites, where she oversaw study site performance.

After starting her career as research assistant, early experience with community outreach catalyzed Rachel’s career focus and management progression in several patient advocacy and experience roles of increasing responsibility at research site networks.

Rachel is a licensed Registered Nurse, she earned a master’s degree in public health from the University of West Florida and a bachelor’s degree food science and nutrition from the University of Florida.

As Executive Director, Clinical Operations, Hollis Ryan leads site operations, with responsibility for site capacity and utilization planning, and clinical training.

Hollis has 18 years’ experience in clinical research. Her experience includes positions as Clinical Research Coordinator, Clinical Trials Administrator, Site Manager, Regional Director, and Director of Clinical Operations, managing over 200 Phase II – IV investigational drug and medical device trials. In these roles, her responsibilities included activities supporting protocol development, SOP writing, publications, process improvements, budget management, and overall execution of clinical trials.

Hollis earned a bachelor of science degree from Troy University and is a certified clinical research coordinator. She currently serves as President of the Central Alabama Chapter of the Association of Clinical Research Professionals (ACRP).

As Executive Director, Human Resources, Kara Chase develops and implements the company’s human resource strategies and initiatives across talent management, diversity and inclusion, employee relations, culture and engagement, compensation and benefits, and training and development.

Kara has 25 years of human resources experience, including more than 12 years in clinical research. With an expansive background in human resources leadership, strategy and management that ranges from small to large organizations, Kara brings specialization in post-acquisition cultural integrations. In 2012, she was the recipient of the Gold Best in Biz Award as Human Resources Executive of the Year, followed by the Silver Best in Biz Award as Human Resources Executive of the Year in 2013.

Kara earned a bachelor’s degree in human resources management and business administration from King’s College She holds both SPHR and SHRM-SCP certifications and is a member of the Society for Human Resource Management.

Clinical Research as Clinical Care When Vaccines are in Short Supply.

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Casey Orvin

Chris Prader

Rachel Truxall

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Kara Chase