Health Decisions Exceeds Goals for Universal Flu Vaccine Study
Health Decisions, a full-service clinical research organization (CRO) specializing in high-efficiency adaptive solutions, has completed enrollment for a Phase II universal flu vaccine study only three weeks after the first site initiation visit and less than three months after the partnership was contracted. If the candidate is proven effective, millions of flu vaccine doses could be produced in a time frame of weeks instead of months, a breakthrough with major positive implications for global populations threatened by seasonal and pandemic influenza strains like the H1N1 Swine Flu.
The candidate is produced through a proprietary process using a new, versatile growth environment that promotes faster maturation than chicken eggs—the standard environment since 1943. The Phase II study administers the candidate in conjunction with the standard flu vaccine to assess safety, immunogenicity and antibody response.
The vaccine’s developers chose to partner with Health Decisions for the CRO’s ability to meet two critical requirements that were vital to the study’s early success. First, all subjects had to be administered doses before the standard flu vaccine, to which the candidate was being compared, reached its expiration date. Missing this deadline would have meant losing months of progress waiting for a new batch to become available. In addition, reactogenicity data had to be captured, verified and made accessible to the sponsor immediately in order to closely monitor patients’ tolerability levels.
"The sponsor’s tight schedule and safety monitoring requirements presented a great opportunity for us to prove the capabilities of our Agile Clinical Development platform,” said Kelly Murray, associate director of clinical affairs at Health Decisions. “We’re proud to support such an important medical breakthrough, and look forward to a bright future working with the sponsor to make vaccines more accessible to patients.”
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
SOUL Trial Shows Oral Semaglutide Significantly Reduces Cardiovascular Risk in Type 2 Diabetes
April 3rd 2025Phase III SOUL trial shows daily oral semaglutide lowers the risk of major adverse cardiovascular events in patients with type 2 diabetes and atherosclerotic cardiovascular disease or chronic kidney disease, with benefits consistent with injectable semaglutide and other GLP-1 receptor agonists.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
