Medical device development must address some unique challenges that have grown over the last decade due to increasing medical device complexity, a more complex regulatory framework catching up with the industry, and an established and variable standard clinical practice to compete with: These factors have a major impact on the medical device development cycle, which...
Introduction When approached for an early-in-illness schizophrenia trial, Premier Research knew that patient recruitment would be challenging and require creative approaches for success. Based on our experience in mental illness studies and with this indication, we recognized the importance of identifying sites where patients were already being diagnosed and treated. To achieve this, the Premier...
Introduction For those who have been through it, a rescue study transition from one contract research organization (CRO) to another can be a difficult ordeal, often accompanied by logistical hurdles and communication challenges. When a sponsor of a Phase 1 dose expansion trial for a novel oncology therapy contacted Premier Research, they were more than...
Introduction Over the past decade, significant advances have improved our understanding of the genetic and molecular mechanisms that lead to cancer. And yet, a recent review of the oncology drugs approved by the U.S. Food and Drug Administration (FDA) on the basis of improvement in tumor response rates showed only 10 percent of these therapies...
Background Cervical cancer is the fourth most common cancer in women. Despite being highly preventable, over 600,000 women were diagnosed and more than 340,000 died from the disease worldwide in 2020. The majority of cervical cancers are caused by infection with human papillomavirus (HPV) and the implementation of HPV vaccines has been shown to reduce...
The challenge of enrollment for observational research Patient enrollment and retention for investigational trials are notoriously difficult. How is enrollment affected when there is no direct benefit to the patient: no breakthrough study drug with the potential to cure, no added caregiver time, no meaningful compensation for participating? Observational studies, by design, demand a continuation...
August 25th, 20222:00 p.m. AET / 1:00 p.m. KST / 12:00 p.m. SGT Conducting rigorous assessments and obtaining the highest-quality data are essential to dermatology clinical research. Traditional clinical trial designs can pose obstacles for patients with busy work and personal lives, especially if they live far from a study site. Decentralized trials open opportunities...
Each year, nearly 85 million Americans see a physician for at least one skin disease, with $75 billion in direct costs to the U.S. healthcare system.[i] While the FDA has approved more than 110 dermatology drugs, these treatments address only about 30 indications, leaving the vast majority of known skin conditions unaddressed. In recent years,...
Typically, when people talk about a full-service contract research organization (CRO) they mean a group that handles every aspect of a clinical study, supplying the personnel, the systems, and the processes. The sponsor is spared all operational involvement with the full-service model, simply receiving key information at specified intervals. This model works very well for...
Natural history studies play a crucial role in rare disease drug development, providing insights that advance discovery and shape clinical trial design. The benefits of these studies also extend to understanding patient journeys, clarifying the standard of care, identifying disease-specific centers of excellence, and surfacing opportunities to improve patient care. In this blog post, we...